Search

opioids - search results

If you're not happy with the results, please do another search

0 1663

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.

0 801

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 2058

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

0 784

 

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.”

0 1049

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 1039

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

0 330

Cara Therapeutics Reports Continuation of Phase 3 Trial of I.V. CR845 in Postoperative Pain Following Interim Assessment

- Trial will continue to test two doses of CR845 and aims to enroll up to 450 patients -

- Both doses of CR845 well tolerated -

- Trial completion expected in the fourth quarter of 2017 -

 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 the completion of a prespecified interim conditional power analysis of its adaptive Phase 3 trial of I.V. CR845. Based on the guidance of the Independent Data Monitoring Committee (IDMC), the trial will continue to test two doses of CR845 (1.0, and 0.5 μg/kg I.V.) versus placebo in up to 450 patients undergoing abdominal surgery. The IDMC also reviewed the available safety information, including serum sodium levels, and confirmed that both doses of CR845 were well tolerated with no significant changes in the monitored safety parameters.

“We look forward to continuing to test both doses of I.V. CR845 in our ongoing adaptive Phase 3 trial following the IDMC’s interim assessment analysis, and are encouraged by the overall clinical safety profile of CR845 for use in the postoperative setting,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “There remains a clear unmet need for effective analgesic agents that lack the serious safety risks inherent in current opioids. We anticipate completing enrollment of this trial later this year.”

About the Ongoing CLIN3001 Postoperative Pain Trial

The CLIN3001 Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients. The trial is enrolling up to 450 patients at 30 clinical trial sites within the United States. Two doses of I.V. CR845 (1.0, and 0.5μ g/kg I.V.) are being compared to placebo. The primary efficacy measure is the Change in Pain Intensity over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale (NRS) score collected at prespecified time points through 24 hours. Postoperative nausea and vomiting (PONV) will be evaluated as a secondary efficacy measure.

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 pain intensity and opioid-related side effects. In more than 1200 subjects dosed to date, CR845 was observed 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, and lacking the respiratory depression and abuse liability of mu opioid receptor agonists. Top-line data from a Phase 2b trial of Oral CR845 in chronic pain associated with osteoarthritis are expected in the second quarter of 2017.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical 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, led by CR845, 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 opioid pain therapeutics.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing of the completion of the ongoing CLIN3001 postoperative pain trial of I.V. CR845 and the safety and efficacy results of the ongoing CLIN3001 clinical trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of Cara’s Annual Report on Form 10-K for the year ended December 31, 2016 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

0 736
Marijuana-Stocks-Cannabis-botles

There is a large issue big pharmaceutical companies are facing in the coming years. Many people are choosing marijuana to treat their conditions rather than opioids and many other prescription drugs.

Former professional athletes from the NFL and NBA have come into the spotlight stating that the leagues should let them at least give cannabis a shot to manage their constant pain, given the ongoing opioid epidemic.

There is a myriad of studies underway proving the health benefits of medical marijuana for pain management in addition to other conditions. It wasn’t until recently that a study conducted found what the massive switch to natural medical marijuana away from large pharma could do to the latter industry.

The study done by New Frontier Data, a Washington, D.C. – based date analysts company focused on the legal marijuana industry, decided to research the effects of people using marijuana as opposed to prescription drugs for the nine illnesses most commonly treated by cannabis.

Their findings showed that Big Pharma could lose almost five billion dollars per year. This is a staggering number, but it does have a catch. The study is based on the assumption that marijuana will become legal across all fifty states.

This may seem highly unlikely with our current leadership, but it still proves what is at stake for the medical marijuana industry and what Big Pharma could lose.

The group then considered a twenty-sixteen study which found that the amount of prescriptions for drugs dropped by eleven percent among older patients in the states that medical cannabis is legal.

New Frontier gathered data on the amount of money spent on prescriptions for the following conditions; Chronic pain, PTSD, Sleep disorders, Anxiety, Nerve pain, Chemotherapy— induced nausea, Tourettes Syndrome, Glaucoma, Seizures/epilepsy. The analysis showed that medical marijuana could take away between four and five billion dollars a year from pharmaceutical sales.

This study is dependent on the idea that marijuana may find its rightful legalization in the upcoming years across the nation. If this occurs, people could have access to a preferred medicine with less side effects, and a lessened chance of addition than the opposing prescription drugs.

0 618
marijuana-stocks-cannbais-USA

The United States marijuana industry has come under attack and this attack is being fueled by false statements and claims from various members of the White House administration.

Yesterday, Deputy Attorney General Rod Rosenstein added fuel to the fire when he appeared before the Senate and House Appropriations committees.

Rosenberg called marijuana an unlawful drug from a legal and scientific perspective, and said it is properly scheduled under Schedule I. He also said that the Cole Memo remains its policy for the moment and that there may be an opportunity to review it in the future.

Cannabis is an Effective Treatment for Millions in America

Currently, 30 states and the District of Columbia allow for use of medical cannabis. The medical cannabis industry is a multi-billion-dollar industry that employs hundreds of thousands of people.

With almost 2 million patients across the country, the medical marijuana industry is just getting started and has already improved daily life for millions-on-millions of people across the globe.

Cannabis Legalization Provides Relief

Painkillers have become a serious issue in the United States. During the past 15 years, America has seen a tremendous growth in both the sales of prescription opiates and the number of people who die each year from abusing them. Researchers from the RAND Corporation and the University of California-Irvine (UCI) may have found the answer and that is marijuana.

The researchers discovered a reduction in the number of opioids related overdoses, as well as a reduction in number of admissions to addiction treatment center in states that legalized marijuana. The researchers also found that these states experienced significant reductions in both measures if they also legalized marijuana dispensaries.

A study conducted by the University of Georgia in 2016 reported a significant reduction in Medicare Part D prescriptions (the Medicare prescription drug benefit that subsidizes prescription drug costs) in states that have legalized medical marijuana, including an 11% reduction in pain-related prescriptions.

In 2014, a study conducted by the Journal of the American Medical Association reported a 25% decline in accidental opioid deaths in states where medical marijuana is legal.

Improving Daily Life Across the World

Cannabis can treat countless debilitating diseases and improve the daily life of millions of people around the world.  Despite all the fake news being reported from the White House pertaining to medical cannabis, the facts don’t lie.
Although the United States is led by an Attorney General who has called the use of medical cannabis as desperate and said it is only slightly less awful than heroin, cannabis continues to save lives every day.

Cannabis is a medicine and it is time for the United States to treat it as one.

0 570

Tetra Bio-Pharma Announces the Completion of its Phase 1 Safety Report to Health Canada and Launches the Preparation of a Phase III Clinical Trial for PPP001 with Sante Cannabis

After a detailed review of the clinical data, the Company is pleased to announce that the safety data met its expectations and that the pharmacokinetic data demonstrated that the inhalation of PPP001 achieved the targeted plasma levels of THC that could potentially achieve pain relief in cancer patients. The Phase I trial provides the key information required by the medical experts of Santé Cannabis to design a Phase III clinical trial for cancer patients. The Company expects to launch the Phase III clinical trial by Q4/17 – Q1/18.

“Shareholders should be proud to know how quickly we have moved through the Phase I trial and we are now progressing on an accelerated path to the Phase III trial which is, relatively speaking, a tremendous accomplishment for the organization and a testament of the excellent work undertaken by Dr. Chamberland and his team,” said Andre Rancourt CEO of Tetra Bio-Pharma. “Tetra has achieved a significant milestone in the execution of its business plan of becoming a global leader in pharmaceutical cannabis.”

“The development of PPP001 for patients with advanced cancer is an important commitment for Tetra. Cancer patients suffer from severe pain which is often accompanied by depression and insomnia. Medical marijuana has been shown to help patients beyond the immediate benefit of pain relief. With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of life of advanced cancer patients. Importantly, our clinical program will also address the potential of PPP001 to reduce the reliance on opioids for management of severe pain. The Company will continue to maintain a transparent and direct line of communication with Health Canada (Therapeutic Products Directorate and Controlled Drug Substances) and the U.S. FDA to ensure that we address the issues required for drug approval. PPP001 is about patients first,” commented Dr. Chamberland CSO of Tetra Bio-Pharma.

In late May 2017, Tetra had a pre-submission consultation meeting with the Therapeutic Products Directorate (TPD) of Health Canada to brief the agency on the safety findings and pharmacokinetics of PPP001, and to discuss its clinical development program leading to the submission of a New Drug Submission for a first indication in advanced cancer patients with pain. Health Canada provided feedback and guidance on Tetra’s clinical development program and the proposed Phase III clinical trial.

Tetra and Santé Cannabis have focused the clinical development on a first indication in patients with advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis. “Medical cannabis has clear potential for the treatment of cancer pain that is partially or not responsive to opioid therapies and other analgesics,” states Dr. Antonio Vigano, lead trial physician and Research Director of Santé Cannabis. “It is our obligation to confirm the safety, efficacy and tolerability of PPP001 and to ensure that we are helping cancer patients by offering every possible tool to control pain and improve quality of life.”

The Company will be completing the research required to ensure that PPP001 conforms to the chemistry and manufacturing requirements under the Food and Drug regulations to secure its Notice of Compliance and a Drug Identification Number (DIN).

Subscribe Now & Begin Receiving Marijuana Stocks News, Articles, Trade Alerts & MORE, all 100% FREE!

We are your #1 source for all things Marijuana Stocks, Subscribe Below!

Privacy Policy: We will NEVER share, sell, barter, etc. any of our subscribers information for any reason ever! By subscribing you agree we can send you via email our free e-newsletter on marijuana stocks related, articles, news and trade alerts. Further questions please contact privacy@marijuanastocks.com
Ad Placements