INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced that its clinical development collaboration with the Center for Medicinal Cannabis Research (CMCR) at UC San Diego School of Medicine has expanded to include plans for a new study to explore the effectiveness of the company’s proprietary cannabidiol (CBD) oral solution on symptoms, neurocognition, neuroimmune response and eating behavior in patients with early psychosis.
The two organizations announced their collaboration in April with plans for a CMCR study of CBD from INSYS in pediatric patients with autism. As part of the collaboration, INSYS has agreed to provide its proprietary formulation of pharmaceutical-grade CBD oral solution for both CMCR studies, which are expected to start in 2019, with others under consideration.
“As a result of this new study announced today, we expect to learn whether CBD reduces symptoms and improves cognition in early psychosis,” said Kristin Cadenhead, MD, professor of psychiatry at UC San Diego. “In addition, we plan to explore the effect of CBD on the biological response to psychosocial stress, and the effect of CBD on the eating behavior induced by antipsychotic medication.” CMCR Director Igor Grant, MD, added: “Cannabinoids such as CBD deserve rigorous study into their possible value in the treatment of neuropsychiatric disorders. We are pleased that through our collaboration with INSYS we have an opportunity to advance the field.”
More information about the study will be available at https://www.cmcr.ucsd.edu/.
INSYS has a state-of-the-art manufacturing facility with unique capabilities to produce pharmaceutical-grade cannabinoids, including CBD. As part its R&D program, the company has ongoing clinical trials of CBD oral solution as an investigational treatment for childhood absence epilepsy (Phase 2), infantile spasms (Phase 3) and Prader-Willi syndrome (Phase 2). INSYS strategically pursues collaborations to augment its internal R&D.
“Our partnership with CMCR has the potential to significantly advance the clinical science of pharmaceutical cannabinoids across a range of indications,” said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. “Studies of our CBD oral solution in autism and early psychosis are among several conditions that our clinical research teams are considering for evaluation through this partnership.”
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 autism and early psychosis and the expectation that INSYS has the ability to produce pharmaceutical-grade cannabinoids, including CBD, if and when needed, in its manufacturing facility. 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.
CONTACT: Corporate Communications Investor Relations Joe McGrath Jackie Marcus or Chris Hodges INSYS Therapeutics Alpha IR Group 480-500-3101 312-445-2870 email@example.com INSY@alpha-ir.com
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