INSYS has agreed to provide its pharmaceutical-grade CBD oral solution—already under clinical evaluation in company-sponsored trials for treatment of refractory pediatric epilepsies—for this CMCR study, which is scheduled to start in 2019.
“We appreciate the opportunity to partner with UC San Diego’s Center for Medicinal Cannabis Research, which has significantly advanced the field’s basic and clinical science over the past two decades,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “Our common commitment to evaluating the safety and efficacy of pharmaceutical-grade cannabinoids in a variety of disease states and patient populations has the potential to yield important new treatment options for a range of intractable conditions.”
INSYS has a state-of-the-art manufacturing facility with unique capabilities to produce pharmaceutical-grade cannabinoids, including CBD, with greater than 99 percent purity. As part of its R&D program, the company recently initiated clinical trials of its proprietary CBD oral solution as an investigational treatment for infantile spasms (Phase 3) and childhood absence epilepsy (Phase 2). In addition, INSYS announced last week its plans to advance clinical research on dronabinol inhalation beginning in the second half of 2018 through another partnership.
“Investigating the effects of cannabidiol on autism has been a long-term goal for CMCR,” said Igor Grant, M.D., CMCR director and chair of the UC San Diego School of Medicine’s Department of Psychiatry. “We are excited to begin this clinical trial and unlock additional, evidence-based knowledge of how cannabis and cannabinoids can be used as medicines, not only for autism, but in the future for other neurodevelopmental and neuropsychiatric disorders.”
Established in 2000, the UC San Diego Center for Medicinal Cannabis Research (CMCR) has been at the forefront of advancing science and policy relating to the potential clinical benefits and limitations of cannabis and cannabinoids as medicine. CMCR initiated the first therapeutic studies using smoked cannabis in over 20 years, completed key studies regarding the short-term benefits of cannabis for the treatment of neuropathic pain and spasticity, and has numerous active research projects.
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
This news release contains forward-looking statements regarding the potential for the company’s CBD oral solution to become a treatment for symptoms of autism and/or other neurological or psychiatric disorders. These forward-looking statements are based on management’s expectations and assumptions as of the date of this news release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended Dec. 31, 2017 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
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