Insys Therapeutics, an Arizona-based company with manufacturing facilities in Austin, recently announced that the Food and Drug Administration (FDA) has granted orphan drug designation for its product, which will provide the therapy with seven years of market exclusivity, among other financial incentives. Insys is producing and commercializing Cannabidiol, a cannabinoid treatment for Dravet syndrome.
According to the Dravet Syndrome Foundation, this disease, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare form of intractable epilepsy that begins in infancy, causing more prolonged and other seizure types to emerge in the second year of life. Patients with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, including behavioral and developmental delays, movement and balance issues, growth and nutrition issues, chronic infections, sensory integration disorders, and disruptions of the autonomic nervous system (which regulates things such as body temperature and sweating), among others.
Cannabidiol, a compound in cannabis that has significant medicinal benefits, now offers “an alternative to plant derived cannabinoids,” which “will provide significant medical benefits and better address the unmet needs of patients across multiple indications,” explained Michael L. Babich, Insys’ president and chief executive officer, in a press release, adding that the company expects to file an Investigational New Drug Application (IND) for CBD in the second half of 2014.
With more than seven years of research and development experience in the cannabinoid space, Insys currently manufactures Dronabinol and Cannabidiol, both of which are cannabinoids, at its FDA-inspected and Drug Enforcement Administration approved facility in Round Rock, Texas.
Further goals of the company, as BioNews Texas reported last May, could include using Cannabidiol for other indications such as peripheral neuropathy, glioblastoma and addiction to cocaine, heroin, and opioids. In addition to Dravet syndrome, Insys plans to develop treatments for another rare form of pediatric epilepsy, Lennox-Gastaut syndrome.