Austin’s Insys Therapeutics, Inc. has announced that it will produce a tested cannabinoid treatment for epilepsy.
Insys’ manufacturing facility is uniquely positioned to produce commercial quantities of Cannabidiol (CBD), a synthetic, 99% pure form of cannabidiol. Michael L. Babich, President and Chief Executive Officer of Insys, recently announced plans for developing CBD to treat epilepsy in children and adults. “We have a unique opportunity to produce a tested and controlled pharmaceutical cannabinoid treatment that can make a substantial difference in the lives of patients with epilepsy,” Babich said in a press release.
To make this undertaking possible, Insys hired Mark Davis as Senior Clinical Director to oversee operations, which will include development and regulatory services provided by a large international Clinical Research Organization. “We are excited to take these important steps, which we believe pave the way to advance ourpharmaceutical CBD candidate into clinical trials to treat these severe forms of epilepsy,” said Babich.
Babich believes Davis will enhance Insys’s commercial goals, saying that “as a further indication of our commitment to bring to market our pipeline of innovative pharmaceutical CBD therapies that potentially provide significant medical benefits to patients, we are pleased to announce the appointment of Mark Davis as Senior Clinical Director.” Davis hails from Medicis Pharmaceutical Corporation (now Valeant Pharmaceuticals International, Inc.), where he was Executive Director of Clinical Research. Throughout his more than 30 years of experience in pharmaceutical, biotech, and medical device development, Davis has also works at Amgen, Topica Pharmaceuticals, Onyx, Medtronic, and Stiefel Laboratories. Prior to his work, he received a master’s degree in biomedical engineering from the University of Utah.
Furthering the goals of Insys could include using CBD for other indications such as peripheral neuropathy, glioblastoma and addiction to cocaine, heroin, and opioids. Insys intends to pursue orphan drug designation for the indications that qualify as orphan conditions, meaning the patient population is no greater than 200,000 patients. These conditions include Lennox-Gastaut Syndrome, a severe form of childhood-onset epilepsy, and Dravet Syndrome, a rare and catastrophic form of infant-onset intractable epilepsy. Insys will file an Investigational New Drug application later this year for CBD to treat these conditions.