INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced that its collaboration with the Center for Medicinal Cannabis Research (CMCR) at the University of California (UC) San Diego School of Medicine has added a third study.
This additional study will evaluate the pharmacological effects of cannabidiol (CBD) oral solution from INSYS on anxiety associated with anorexia nervosa in adult patients. The previous two collaborative CMCR studies, announced earlier this year, will focus on CBD in the treatment of severe symptoms of autism in pediatric patients and early psychosis in adult patients. The IND (investigational new drug) application for the autism study is on track for filing in the fourth quarter of 2018.
Separately, INSYS has initiated three clinical trials of its CBD oral solution–for childhood absence epilepsy (Phase 2), infantile spasms (Phase 3) and Prader-Willi syndrome (Phase 2)–and is actively considering others as a sponsor or collaborator. In addition, the company continues to support an ongoing study of CBD as a potential treatment for cocaine dependence with the University of Montreal and the Canadian Institutes of Health Research.
“Anorexia nervosa is difficult to treat and, in some cases, may be a fatal condition,” said Emily Gray, MD, clinical assistant professor of psychiatry at UC San Diego. “There is preliminary research that suggests cannabinoids may be beneficial in treating this and other eating disorders. The administration of CBD is of interest because of the possibility that this drug might reduce anxiety, and perhaps normalize reward and motivation. The UC San Diego Eating Disorders Center has been at the forefront of understanding the neurobiology of these diseases and looks forward to further investigating.”
INSYS has a state-of-the-art manufacturing facility with unique capabilities to produce pharmaceutical-grade cannabinoids, including CBD.
“With three CMCR studies of our CBD oral solution already planned, this collaboration has contributed to our momentum,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “We also look forward to reporting the results of our company-sponsored CBD trials.”
CMCR Director Igor Grant, MD, professor and chair of the psychiatry department at the UC San Diego School of Medicine, added: “Cannabinoids, and cannabidiol specifically, have generated much excitement as promising new avenues of treatment, but much needs to be learned about their indications, efficacy and limitations. This study in adult patients with anorexia nervosa moves to fill critical knowledge gaps.”
More information on these and other CMCR studies is online at https://www.cmcr.ucsd.edu/.
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 anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, 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 anorexia nervosa, autism, early psychosis and cocaine dependence, as well childhood absence epilepsy, infantile spasms and Prader-Willi syndrome. 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.
Jackie Marcus or Chris Hodges
Alpha IR Group
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