SOURCE: INSYS Therapeutics
PHOENIX, AZ--(Marketwired - Feb 26, 2015) - Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its pharmaceutical cannabidiol ("CBD") formulation for the treatment of Dravet syndrome, a rare form of childhood epilepsy.
FDA's Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need.A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval to get important new drugs to the patient earlier.
"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," said Michael L. Babich, President and Chief Executive Officer of Insys."Rapid advancement of our pharmaceutical CBD 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 I/pharmacokinetic study in epilepsy patients and a Phase III clinical trial in patients suffering from Dravet syndrome and Lennox Gastaut syndrome, a second rare form of pediatric epilepsy for which our pharmaceutical CBD has received orphan drug designation."
The Company expects that Insys' new, DEA-inspected facility in Round Rock, Texas will allow the Company to manufacture ample quantities of CBD for its research and commercial plans.
About Pharmaceutical CBD Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.
Insys' pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment.The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.
About Dravet Syndrome Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and catastrophic form of intractable epilepsy that begins in infancy. Initial seizures are most often prolonged events and in the second year of life other seizure types begin to emerge. Development remains on track initially, with plateaus and a progressive decline typically beginning in the second year of life. Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also need to be properly treated and managed.
About Insys Therapeutics, Inc. Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using our proprietary sublingual spray technology and our capability to develop pharmaceutical cannabinoids, Insys addresses the clinical shortcomings of existing commercial products. Insys currently markets two products, Subsys, which is sublingual Fentanyl spray for breakthrough cancer pain, and a generic version of Dronabinol (THC) capsules. Our lead product candidate is Dronabinol Oral Solution, a proprietary orally administered liquid formulation of dronabinol.Insys is also developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol.
Subsys is a registered trademark of Insys Therapeutics, Inc.
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Insys Therapeutics Announces Its Pharmaceutical Cannabidiol Received Fast Track Designation From FDA for the Treatment ...