US orphan status for Insys Therapeutics' cannabidiol for rare form of epilepsy

25 June 2014

US specialty pharma firm Insys Therapeutics (Nasdaq: INSY) says that the US Food and Drug Administration has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Lennox-Gastaut syndrome, a rare pediatric-onset epilepsy.

"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 Michael Babich, president and chief executive.

IND filing expected second-half 2014

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