Clinical data from a long-term safety study of pharmaceutical-grade cannabidiol (CBD) oral solution as an investigational treatment for refractory pediatric epilepsy will be presented on Dec. 3 at the 2018 American Epilepsy Society (AES) annual meeting in New Orleans. The product candidate evaluated in the study is from INSYS Therapeutics, Inc. (INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology.
The AES poster presentation on this multicenter, open-label, flexible-dose study (INS011-14-030) is titled “Long-Term Safety of Pharmaceutical Cannabidiol Oral Solution as Adjunctive Treatment for Pediatric Patients with Treatment-Resistant Epilepsy.” The presentation will be made by James W. Wheless, M.D., professor and chief of pediatric neurology at the University of Tennessee Health Science Center in Memphis, where he directs the Neuroscience Institute & Le Bonheur Comprehensive Epilepsy at Le Bonheur Children’s Hospital and holds the Le Bonheur Chair in Pediatric Neurology.
“We look forward to presenting the long-term safety data of our CBD,” said Ahmed Elkashef, M.D., vice president of clinical development for INSYS Therapeutics. “These data will inform us and the scientific community as we continue our development programs and provide investigational CBD through the expanded access program.”
Other clinical research on CBD from INSYS includes three ongoing company-sponsored trials: childhood absence epilepsy (Phase 2), infantile spasms (Phase 3) and Prader-Willi syndrome (Phase 2). Results from the Phase 2 trial in childhood absence epilepsy are expected soon, pending completion of enrollment. All three trials are actively enrolling patients.
In addition, INSYS has formed collaborative research partnerships with leading academic institutions to advance the medical science of pharmaceutical cannabinoids in other disease states, including autism, early psychosis and anxiety in anorexia nervosa with the University of California San Diego’s Center for Medicinal Cannabis Research, and cocaine addiction with the University of Montreal and the Canadian Institutes of Health Research.
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 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, risks described in our filings with the United States Securities and Exchange Commission, including those 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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