Insys Therapeutics Receives Orphan Drug Status For Cannabidiol Epilepsy Treatment
Insys Therapeutics has announced that it is receiving orphan drug designation for its pharmaceutical cannabidiol (CBD), which is used to treat Lennox-Gastaut Syndrome — a rare form of pediatric-onset epilepsy. The orphan drug designation will allow Insys to gain a seven year period of marketing exclusivity in the U.S. if the drug is ultimately approved by the FDA and put on the market.
Insys has been researching and developing pharmaceutical cannabinoids for seven years, and the company says it will continue to develop new treatments for Dravet Syndrome, which is another rare form of pediatric epilepsy. Insys is also looking to use pharmaceutical CBD to treat other areas, such as glioblastoma, adult epilepsy, chemotherapy-induced peripheral neuropathy, in addition to cocaine, heroin, and opioid addictions.
Michael L. Babich, the President and Chief Executive Officer of Insys Therapeutics, commented on the orphan drug designation. “With no cure and persistence of seizures with current antiepileptic medications, the orphan drug designation recognizes the significant, unmet need that exists among children with this severe form of epilepsy and the teams who provide their care," said Babich. "We have the unique opportunity to test a controlled pharmaceutical CBD product for Lennox-Gastaut Syndrome, and our company is committed to advancing cannabinoid therapies that have the potential to provide significant medical benefits to patients across multiple indications. We expect to file an Investigational New Drug Application (IND) for CBD in the second half of 2014.”
Using cannabis-based products for medical purposes has been relatively controversial in political circles, but pharmaceutical companies have been increasingly engaging in the research and development of cannabis based products, especially to treat epilepsy and diseases which cause seizures.