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FDA grants fast track designation to cannabidiol for Dravet syndrome
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Insys Therapeutics recently announced that the FDA has granted fast track designation to a pharmaceutical cannabidiol for the treatment of Dravet syndrome, a rare form of childhood epilepsy.
Also known as Severe Myoclonic Epilepsy in infancy, Dravet syndrome is a drug-resistant epilepsy that occurs in the first year of life of previously healthy children. Preliminary seizures are most often prolonged events and, in the second year of life, other seizure types begin to emerge, including prolonged and repeated febrile and afebrile generalized or unilateral convulsive seizures.
During the course of epilepsy, child development initially remains on track with plateaus and a progressive decline typically beginning in the second year of life, where cognitive deterioration becomes evident, exhibiting interictal myoclonus, clumsiness and ataxia.
Patients with Dravet syndrome typically experience a higher rate of “sudden unexplained death in epilepsy” (or SUDEP) and have associated conditions that need to be treated and managed concurrently.
“Coupled with our candidate’s orphan drug designation in Dravet syndrome, fast track designation represents significant additional support of our goal of addressing the significant medical need of children suffering from this rare and catastrophic treatment-resistant form of pediatric epilepsy,” Michael L. Babich, president and CEO of Insys Therapeutics, said in a press release.
“Rapid advancement of our pharmaceutical [cannabidiol] program is a key priority for Insys, and we are pleased to be initiating clinical trials with this program in 2015. These include a phase 1 pharmacokinetic study in epilepsy patients and a phase 3 clinical trial in patients suffering from Dravet syndrome and Lennox Gastaut syndrome, a second rare form of pediatric epilepsy for which our pharmaceutical [cannabidiol] has received orphan drug designation.”
The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of the pharmaceutical cannabidiol program to improve the efficiency of product development.