Insys Therapeutics Inc (NASDAQ:INSY), a specialty pharmaceutical company, announced on Wednesday that the US Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Dravet syndrome, a rare pediatric-onset epilepsy.

“There is presently no cure for this catastrophic form of epilepsy, and the significant, unmet need is recognized by the orphan drug designation we received today for our pharmaceutical CBD,” said Michael L. Babich, President and Chief Executive Officer.

“Our pharmaceutical CBD is an alternative to plant derived cannabinoids, one which we believe will provide significant medical benefits and better address the unmet needs of patients across multiple indications including Dravet syndrome. We expect to file an Investigational New Drug Application (IND) for CBD in the second half of 2014,” he added.

In addition to Dravet syndrome, Insys said it plans to develop treatments for another rare form of pediatric epilepsy, Lennox-Gastaut syndrome, for which its pharmaceutical CBD recently received orphan drug designation. The company is also evaluating the potential use of pharmaceutical CBD in several additional indications, including adult epilepsy, chemotherapy-induced peripheral neuropathy, addiction in cocaine, heroin and opioids and glioblastoma.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the US. The designation provides the drug developer with a seven-year period of US marketing exclusivity, as well as certain financial incentives that can help support its development. Shares in Insys were up 0.8% to $32.46 shortly after midday on Wednesday. The company has traded between $9.67 and $57.91 over the past 52 weeks.