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0 1554

Americans think it’s safer to use marijuana than opioids to relieve pain, but they were less comfortable with children and pregnant women using the drug to treat medical conditions, according to a recent Yahoo/Marist poll. Two-thirds of the respondents in the telephone survey said opioid drugs such as Vicodin or OxyContin are “riskier” to use than marijuana, even when the pain pills are prescribed by a doctor. Only one in five said marijuana was riskier than opioids. The rest weren’t sure.

Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. Some 2 million Americans are thought to be hooked on the pills. Last month, President Donald J. Trump appointed an opioid commission to look into the problem. Marijuana by itself is not fatal. Doctors technically don’t prescribe it for pain or other purposes but most states that allow medical marijuana do require patients to get a doctor’s written recommendation to purchase it to treat their conditions.

Among those answering the Yahoo/Marist poll, 83% said the drug should be legal nationally for medical treatment. However, 70% said it is not acceptable for pregnant women to use marijuana to reduce nausea or pain. And the survey respondents were about evenly divided on whether marijuana should be recommended for children if it were legal. The survey respondents were deeply divided on how Trump should approach marijuana: 38% said he shouldn’t be as tough about enforcing federal laws against recreational marijuana use as President Barack Obama, whose policy generally was to leave states alone.

Another 30% said Trump should take a harder line than Obama, while the rest weren’t sure or said Trump should treat it about the same as Obama did. Trump’s administration has sent mixed messages to the 28 states and Washington, D.C., in violation of federal drug law when it comes to marijuana. Trump said as a candidate that states should be allowed to tinker with marijuana laws. However, new U.S. Attorney General Jeff Sessions has said marijuana is dangerous and marijuana changes by states should not be allowed. There has been no action yet by the U.S. Justice Department or any other federal agencies to crack down on states violating the Controlled Substances Act, which bans marijuana for any use.

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In states where medical marijuana is legal, a new study finds that fewer motorists killed in traffic accidents test positive for opioids-providing further evidence that cannabis medicine brings about a reduction in the use of prescription painkillers. Researchers from Columbia University’s Mailman School of Public Health say that in a recent investigation of federal data involving motor vehicle accidents, they found fewer drivers who died as a result of a fatal automobile accident tested positive for opioids in those states that have passed laws allowing marijuana to be used for medicinal purposes.

“We would expect the adverse consequences of opioid use to decrease over time in states where medical marijuana use is legal, as individuals substitute marijuana for opioids in the treatment of severe or chronic pain,” lead study author June H. Kim said in a press release obtained by the Washington Post.

Researchers concluded that the analysis, which was published this week in the American Journal of Public Health, provided significant proof that “In states with medical marijuana laws, fewer individuals are using opioids.” This is not the first time a study has emerged suggesting a decrease in opioid use in states with medical marijuana laws on the books. Over the summer, a study published in Health Affairs found that prescription drug claims in medical marijuana states are on the decline.

Researchers from the University of Georgia concluded that “The use of prescription drugs for which marijuana could serve as a clinical alternative fell significantly, once a medical marijuana law was implemented.” This data might help explain why the pharmaceutical industry is working to prevent marijuana legalization from happening in some states.

It was recently revealed that Insys Therapeutics chipped in a whopping $500,000 to combat a recreational marijuana ballot measure in Arizona. Ironically, this is the same drug manufacturer that recently won approval from the U.S. Food and Drug Administration to manufacture a synthetic form of marijuana to be marketed to AIDS and cancer patients.

Despite medical marijuana being legal in over half the United States, the federal government is still not ready to loosen some of the restrictions that have prevented the herb from being studied to find its true therapeutic benefit. Incidentally, there have never been any reports of a marijuana overdose death.

0 2004

Cara Therapeutics Selected to Present at the 2016 International Conference on Opioids

  • Leading experts to discuss unique pharmacology of peripherally selective opioids to manage chronic and acute pain during opening session
  • Company to present positive data from Phase 2a study of Oral CR845 in chronic pain patients

Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced that it was selected to deliver a presentation  titled “Kappa Opioid Receptor Agonists (KORAs), a Novel Pharmacology for the Treatment of Acute and Chronic Pain” at the International Conference on Opioids, which will be held June 5-7, 2016 in Boston.

Three experts in the field of clinical research and clinical practice will discuss the latest data and clinical developments in the treatment of acute and chronic pain, and will share results from Cara’s human abuse liability study of I.V. CR845. CR845 is Cara’s first-in-class peripherally selective kappa opioid agonist with potential to be the only Schedule V or non-scheduled opioid for acute and chronic pain.

Details of the presentation are as follows:

Date: Sunday, June 5, 2016
Time: 9:15 – 10:00 a.m. ET
Location: The Joseph B. Martin Conference Center at Harvard Medical School
Experts:

  • Joseph Stauffer, D.O., M.B.A., Chief Medical Officer, Cara Therapeutics; Assistant Professor, Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine
  • TJ Gan, M.D., M.H.S., F.R.C.A., Professor and Chairman of the Department of Anesthesiology, Stony Brook School of Medicine
  • Lynn Webster, M.D., Vice President of Scientific Affairs, PRA Health Sciences

In addition, Dr. Stauffer will present a poster detailing positive data from Cara’s Phase 2a study of the oral formulation of CR845 in osteoarthritis patients.

Title: “The Safety, Tolerability, and Effectiveness of Orally Administered CR845, a Peripherally Acting Kappa Opioid Agonist, in Patients with Osteoarthritis of the Knee or Hip”
Date: Monday, June 6, 2016
Times: 10:00 – 10:30 a.m., 12:30 – 1:30 p.m., and 3:30 – 4:00 p.m. ET
Location: The Joseph B. Martin Conference Center, second floor

For more information on the International Conference on Opioids, visithttp://www.opioidconference.org/Home_Page.html.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects. In a human abuse liability trial, I.V. CR845 demonstrated statistically significant reductions in “drug liking,” “feeling high,” “overall liking,” and “take drug again” scores in comparison to I.V. pentazocine, a Schedule IV analgesic. In more than 635 subjects dosed to date, I.V. CR845 was found to be well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists.

An oral formulation of CR845 has also been evaluated in a Phase 2a study in osteoarthritis patients and was shown to be well tolerated with twice a day dosing for two weeks.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

Contact:
INVESTOR CONTACT:
Jesse Baumgartner
Stern Investor Relations, Inc.
212-362-1200 
Jesse@sternir.com

MEDIA CONTACT: 
Annie Starr
6 Degrees
973-415-8838 
astarr@6degreespr.com

0 737

 

Those who have access to marijuana usually lower the amount of prescription pills that they consume. In addition, they also lower the amount of alcohol and hard drugs consumed, say the Canadian investigators who recorded the habits of patients with legal medical marijuana.

“Substituting cannabis for one or more of alcohol, illicit drugs or prescription drugs was reported by 87 percent of respondents, with 80.3 percent reporting substitution for prescription drugs, 51.7 percent for alcohol, and 32.6 percent for illicit substances,” the investigators reported.

Those between the ages of 18-40 typically had the highest rates of substitution; that is to say that those who smoked marijuana for pain relief were more likely to use the drug instead of prescription drugs.

“The finding that cannabis was substituted for alcohol and illicit substances suggests that the medical use of cannabis may play a harm reduction role in the context of use of these substances, and could have implications for substance use treatment approaches requiring abstinence from cannabis in the process of reducing the use of other substances,” the authors stated.

The finding was released this September in the journal Drug and Alcohol Review. Many are not at all surprised. A recent recording of the patients involved in Arizona’s medical marijuana program shows that most of those patients “used conventional pharmaceuticals ‘less frequently’ after initiating pot therapy.” Another record of patients participating in Rhode Island’s program produced the same results. A study in 2012 written by investigators at the Centre for Addictions showed that those who suffered from chronic pain used pot along with opioids. According to them, this resulted in “a greater cumulative relief of pain [and] in a reduction in the use of opiates.” According to data published in 2011 by the journal Clinical Pharmacology & Therapeutics, “inhaled cannabis augments the analgesic effect of opioids” and that this “combination may allow for opioid treatment at lower doses with fewer side effects.”

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Cara Therapeutics to Present at the 2015 International Conference on Opioids

 Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Chief Medical Officer Dr. Joseph Stauffer will present data from the Company’s human abuse liability study of I.V. CR845 during a poster session at the International Conference on Opioids (ICOO 2015), being held June 7-9 in Boston, MA. CR845 is Cara’s first-in-class peripherally-selective kappa opioid receptor agonist, which has potential to be the only Schedule V or non-scheduled opioid for acute pain.

The poster presentation details are as follows:

Title: “CR845, a novel peripherally-acting kappa opioid receptor agonist, has low abuse potential compared with pentazocine”
Date: Monday, June 8, 2015
Times: 10:00 — 10:30 a.m., 12:30 — 1:30 p.m., and 3:30-4:30 p.m. EDT
Location: Second Floor, Joseph B. Martin Conference Center at Harvard Medical School, Boston, MA
Poster Number: 48
Speaker: Joseph Stauffer, D.O., M.B.A., Adjunct Assistant Professor, Johns Hopkins University School of Medicine, Chief Medical Officer, Cara Therapeutics

The poster will be on display from 8:00 a.m. until 6:00 p.m. EDT on Monday, June 8.

For more information about ICOO 2015, please visit http://www.opioidconference.org.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and uremic pruritus. In multiple randomized, double blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. In a human abuse liability trial, I.V. CR845 met the primary endpoint showing highly statistically significant reductions (p < 0.0001) in scores for “drug liking,” as well as “feeling high,” “overall liking,” and “take drug again” when compared to I.V. pentazocine, a Schedule IV opioid analgesic.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

Contact:
INVESTOR CONTACT:
Jesse Baumgartner
Stern Investor Relations, Inc.
212-362-1200
Jesse@sternir.com
MEDIA CONTACT:
Annie Starr
6 Degrees
973-415-8838
astarr@6degreespr.com

0 1013

Cara Therapeutics to Present at 3rd Conference on the Therapeutic Potential of Kappa Opioids

  • Company to present data from human abuse liability (HAL) study of I.V. CR845

SHELTON, Conn., April 15, 2015 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Chief Medical Officer Dr. Joseph Stauffer will present data from Cara’s human abuse liability (HAL) study of I.V. CR845 in an oral session at the 3rd Conference on the Therapeutic Potential of Kappa Opioids, held in Chapel Hill, North Carolina. CR845 is the Company’s first-in-class peripherally-selective kappa opioid agonist, which has potential to be the only non-scheduled or Schedule V opioid for acute pain.

The presentation details are as follows:

Title: “CR845, a novel peripherally-acting kappa opioid receptor agonist, has low abuse potential compared with pentazocine”
Date: Wednesday, April 22, 2015
Time: 9:15 a.m. ET
Location: The Carolina Inn, Chapel Hill, North Carolina
Speaker: Joseph Stauffer, DO, MBA

For more information about the 3rd Conference on the Therapeutic Potential of Kappa Opioids, please visithttp://depts.washington.edu/nidactr/kappatherapeutics2015.html.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and uremic pruritus. In multiple randomized, double blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. In a human abuse liability trial, I.V. CR845 met the primary endpoint showing highly statistically significant reductions (p < 0.0001) in scores for “drug liking,” as well as “feeling high,” “overall liking,” and “take drug again” when compared to I.V. pentazocine, a Schedule IV opioid analgesic.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

Contact:
INVESTOR CONTACT:
Jesse Baumgartner
Stern Investor Relations, Inc.
212-362-1200
Jesse@sternir.com
MEDIA CONTACT:
Annie Starr
6 Degrees
973-415-8838
astarr@6degreespr.com

0 638

Lexaria Announces Research on Nonsteroidal Anti-Inflammatory Drugs

Lexaria will conduct in vitro absorption studies utilizing the Company’s technology to examine improvements in absorption across human intestinal tissue, which is expected to be followed by in vivo (animal) studies to confirm the Company’s hypothesis regarding first-pass liver metabolism. The Company postulates that its technology may enable oral delivery of NSAIDs without encountering first-pass liver metabolism, which has the potential to greatly reduce corresponding liver damage.

Pain-relief drugs are comprised mostly of NSAIDs and of opioids and represented a $36.6 billion market in 2014. (MSP, BCC Research – The Global Market for Pain Management Drugs and Devices, September 2015) Long term use or overuse of NSAID’s has been associated with chronic liver conditions that can be debilitating and even cause death.

Common generic forms of NSAIDS are products such as Aspirin, Ibuprofen, Naproxen, Diclofenac and others. Acetaminophen is sometimes included within this list. More effective absorption of NSAIDS may also lead to more effective pain killing properties, thus allowing for fewer opioid medication prescriptions. Prescription based opioid medications are responsible for nearly 18,000 deaths annually in the USA. (National Institute of Health)

Lexaria has a total of 18 patents pending — including the delivery of NSAIDs — and patent applications filed in more than 40 countries worldwide.

Separately, Lexaria also announces it has received US$34,753.40 from the exercise of warrants previously granted. The stock warrants were exercised at prices of US$0.2273 and US$0.1818, for a total of 156,750 common shares being issued. All warrants are being exercised by third parties who are neither officers nor directors of the Company.

No commissions or placement fees have been paid related to the funds received from this warrant exercise. Proceeds will be used for general corporate purposes. Lexaria extends its thanks to its loyal shareholders for their continued support.

The securities referred to herein will not be or have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

About Lexaria

Lexaria Bioscience Corp. is a food biosciences company with a proprietary technology for improved delivery of bioactive compounds. The Company’s lipophilic enhancement technology has been shown to enhance the bioavailability of orally ingested cannabinoids, while also masking taste. This technology promotes healthy ingestion methods, lower overall dosing and higher effectiveness in active molecule delivery. The Company’s technology is patent-protected for cannabidiol (CBD) and all other non-psychoactive cannabinoids, and patent-pending for Tetrahydrocannabinol (THC), other psychoactive cannabinoids, non-steroidal anti-inflammatory drugs (NSAIDs), nicotine and other molecules.

www.lexariabioscience.com

FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements. Statements which are not historical facts are forward-looking statements. The Company makes forward-looking public statements concerning its expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. Such forward-looking statements are estimates reflecting the Company’s best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that other factors will not affect the accuracy of such forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition, the patent application and approval process and other factors which may be identified from time to time in the Company’s public announcements and filings. Plans can change thus there is no assurance that any currently planned R&D will in fact occur, or that any R&D will provide successful or useful data or results. There is no assurance that existing capital is sufficient for the Company’s needs or that it will be able to raise additional capital. There is no assurance that Lexaria will successfully complete any other contemplated or existing technology license agreements, nor that Lexaria’s technology will deliver any improvement in taste or bioavailability with any reliability nor across any product category. There is no assurance that any planned corporate activity, business venture, or initiative will be pursued, or if pursued, will be successful. There is no assurance that any hemp oil or cannabinoid-based product will promote, assist, or maintain any beneficial human health conditions whatsoever, nor that any patent application in the USA or any other nation or under any treaty will result in the award of an actual patent; nor that an award of any actual patent will protect against challenges from unknown third parties. There is no assurance that any of Lexaria’s postulated uses, benefits, or advantages for the patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA)or by Health Canada. Lexaria products are not intended to diagnose, treat, cure or prevent any disease.

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

0 540

Cannabis Science Senior Executives Chair Special Sessions and Deliver a Keynote Speech at the Global Health Catalyst Summit at Harvard Medical School

Mr. Dabney was the keynote speaker for the Cannabis Science versus Cancer and Other Malignancies Session, which was one of the highlights of the three-day Summit. CBIS’ Chief Medical Officer, Dr. Allen Herman, Chaired the Cannabis Science Session, and also delivered a presentation on the epidemiology of cancer and the utilization of opioids in Africa and across the world during the Palliative Care and Mental Health Session. The Company is cleaning up the recorded video feed of the CBIS Session for enhanced clarity; distribution will be made available for viewing over the internet available shortly.

“We were pleased to share our vision with an impressive array of senior health care professionals from the USA and across the world including Africa and the broad African Diaspora. We were particularly pleased with our successful meetings with the Ministers of Health of Namibia, Rwanda, and Kisumu County in Kenya. These African health leaders will help CBIS to define our strategy on the African continent. We are launching an aggressive research program with Dana Farber, and we expect a number of major developments in 2017,” said Dr. Herman.

Mr. Dabney stated, “Our participation in the GHC Summit and this speaking opportunity gave us an opportunity to discuss cutting-edge cannabinoid research with some of the greatest minds in modern medicine globally, as well as to network and explore potential partnerships.” In addition, CBIS’ participation in this Summit provided the company with an opportunity to update stakeholders regarding the progress of the implementation of CBIS’ research agreement with Dana-Farber. “I believe the CBIS/Dana Farber relationship is off to a very good start, and I am excited about the potential of our collaboration. I am even more excited about the groundbreaking initiative with Dana-Farber that we plan to jointly announce in the next few days. This upcoming announcement will change the narrative of how we approach the research, development, and clinical trials of cannabinoid-based medicines globally.”

About Cannabis Science, Inc.

Cannabis Science, Inc. takes advantage of its unique understanding of metabolic processes to provide novel treatment approaches to a number of illnesses for which current treatments and understanding remain unsatisfactory. Cannabinoids have an extensive history dating back thousands of years, and currently, there are a growing number of peer-reviewed scientific publications that document the underlying biochemical pathways that cannabinoids modulate. The Company works with leading experts in drug development, medicinal characterization, and clinical research to develop, produce, and commercialize novel therapeutic approaches for the treatment for illnesses caused by infections as well as for age-related illness. Our initial focus is on skin cancers, HIV/AIDS, and neurological conditions. The Company is proceeding with the research and development of its proprietary drugs as a part of this initial focus: CS-S/BCC-1, CS-TATI-1, and CS-NEURO-1, respectively.

Forward-Looking Statements

This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing words such as “anticipate,” “seek,” intend,” “believe,” “estimate,” “expect,” “project,” “plan,” or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc., does not undertake any duty nor does it intend to update the results of these forward-looking statements. Safe Harbor Statement. The Private Securities Litigation Reform Act of 1995 provides a ‘safe harbor’ for forward looking statements. Certain of the statements contained herein, which are not historical facts are forward looking statements with respect to events, the occurrence of which involved risks and uncertainties. These forward-looking statements may be impacted, either positively or negatively, by various factors. Information concerning potential factors that could affect the company is detailed from time to time in the company’s reports filed with the Securities and Exchange Commission.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=3134954

0 679

Cara Therapeutics Announces Positive Data From Quantitative Phase 1 Trial Measuring Respiratory Safety of I.V. CR845

Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced summary results from its Phase 1 safety trial showing that I.V. CR845 did not significantly differ from placebo across three quantitative measures of respiratory drive in healthy individuals. Respiratory depression remains the most life-threatening side effect of traditional, centrally acting, opioid analgesics, the most commonly used drug class for current treatment of postoperative pain in the United States.

“We are very pleased that I.V. CR845 demonstrated no significant alteration in any measure of respiratory drive, even at doses five-fold greater than the projected therapeutic dose,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “These data further underscore the overall clinical safety profile of CR845 for use in postoperative pain management and continue to differentiate it from traditional mu opioids.”

“There remains a clear unmet need for effective analgesic agents that lack the risk of serious, potentially fatal respiratory depression that is inherent in current opioids,” said Christopher Wu, M.D., Department of Anesthesiology and Critical Care, Johns Hopkins University. “The ability to administer I.V. CR845 without any direct effect on respiratory function is a significant advantage in the acute post-surgical care setting where patients are already at heightened risk of respiratory depression. CR845’s profile also aligns with the most recent standard of care guidelines for postoperative pain, which call for minimizing opioid-related side effects.”

Respiratory Safety Phase 1 Trial Design and Results

The Phase 1 trial was a randomized, double-blind, placebo-controlled, three-way crossover trial of two doses of I.V. CR845 (1.0 ug/kg, and 5.0 ug/kg) versus placebo on three measures of respiratory drive in 15 healthy volunteers. Each subject was randomized to one of three treatment sequences and was administered I.V. bolus placebo, CR845 (1.0 ug/kg) and CR845 (5.0 ug/kg) on sequential 24-hour periods, with CR845 at 5.0 ug/kg representing a projected five-fold supra-therapeutic dose. After each administration, and continuing through four hours post-dosing, end-tidal CO2 (ETCO2), oxygen saturation (SpO2) and respiratory rate were continuously monitored. The primary safety endpoints were: a >10 mmHg sustained (>30 seconds duration) increase in ETCO2 above baseline or to >50 mmHg, and a sustained reduction in SpO2 to <92 percent.

Mean ETC02 pre-dosing ranged from 36.1 ± 3.9 to 37.8 ± 2.9 mmHg across treatment groups. At one hour post-administration, ETC02 values for placebo, CR845 1.0 ug/kg and CR845 5.0 ug/kg treatment groups were numerically and statistically equivalent at 38.1 ± 2.8, 38.1 ± 3.1, and 38.3 ± 2.9 mmHg, respectively. Pre-treatment levels of SpO2 ranged from 98.3 percent ± 1.2 to 98.9 percent ± 1.0 and were measured at 97.8 percent ± 1.2, 98.2 percent ± 1.5 and 97.9 percent ± 1.0 for placebo, CR845 1.0 ug/kg and CR845 5.0 ug/kg treatment groups respectively, at one hour post-treatment. There were no statistically significant differences in any respiratory measures between groups throughout the four-hour observation period and no individual patient met the threshold for a respiratory safety event.

All reported treatment-emergent adverse events were previously reported with CR845 administration and were mild, resolving without intervention.

An oral presentation of this dataset will be part of the Journal Anesthesiology Symposium on Sunday, October 22, 2017 at the American Society of Anesthesiology (ASA) Annual Meeting in Boston, MA.

About Respiratory Depression

Respiratory depression is the most life-threatening side effect of conventional opioids, which act primarily at the mu opioid receptor subtype. Mu opioid receptors are present in high amounts in brainstem areas that control respiration, similar to midbrain and spinal areas that regulate pain perception. A wide variety of factors are involved in determining the effects of mu opioids on breathing, with high potency and speed of onset being well known risk factors, in addition to the presence of sedating medications, the site of surgery and surgical technique used, the presence of underlying disease, and the patient’s age, sex, genetics, and hormonal status, as well as arousal and pain, which can vary substantially between patients. Although death rates from opioid-induced respiratory arrest have declined in many hospitals due to more aggressive patient monitoring, it remains the leading concern of anesthesiologists and pain specialists (1). However, such monitoring is generally not available when patients are discharged home with powerful opioids, and the increasingly high rate of deaths associated with both opioid use and misuse is presently considered a national health crisis.

0 2609

West Virginia Governor Jim Justice signed a bill that makes his state the 29th to allow medical use of marijuana. West Virginia is the sixth state to legalize medical marijuana in the last year and the third (along with Ohio and Pennsylvania) to do so through the legislature. In the other three states: Arkansas, Florida, and North Dakota, voters approved ballot initiatives authorizing medical marijuana last November.

West Virginia’s new law recognizes marijuana as a treatment for patients with terminal illnesses or any of 14 specified conditions, including cancer, HIV/AIDS, epilepsy, multiple sclerosis, Crohn’s disease, post-traumatic stress disorder, and intractable pain. Patients whose doctors recommend marijuana will be able to obtain it in the form of pills, oils, gels, creams, ointments, tinctures, liquids, and vaporizable extracts from state-regulated dispensaries. The dispensaries will not sell buds for smoking or marijuana edibles, although patients can prepare their own at home. The law does not allow home cultivation, and patients can legally possess no more than a month’s supply at a time.

Matt Simon of the Marijuana Policy Project (MPP) stated, “This legislation is going to benefit countless West Virginia patients and families for years to come. Medical marijuana can be effective in treating a variety of debilitating conditions and symptoms. It is a proven pain reliever, and it is far less toxic and less addictive than a lot of prescription drugs. Providing patients with a safer alternative to opioids could turn out to be a godsend for this state.”

One downside to West Virginia’s law is a new standard for driving under the influence of marijuana that erroneously equates impairment with a blood THC level of three nanograms per milliliter. That’s even lower than the unfair and unscientific five-nanogram cutoff that Colorado and Washington adopted when they legalized marijuana for recreational use. As MPP notes, West Virginia’s DUID standard “could make it illegal for some patients to ever drive, since many patients have THC levels at this amount or greater many hours or days after last administering cannabis.”

West Virginia’s rules put it on the less liberal end of a medical marijuana spectrum that ranges from highly permissive (e.g., California) to highly restrictive (e.g., New York). Eight of the 29 medical marijuana states also allow recreational use. Medical use was approved by ballot initiative in 14 of those states, beginning with California in 1996. In the rest, as in West Virginia, medical marijuana laws originated in the state legislature.

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