Insys Therapeutics Inc. (OTC: INSY), a specialty pharmaceutical company developing innovative drug delivery systems and therapeutic molecules, recently announced that it has started dosing pediatric epilepsy patients in a Phase I/II safety and pharmacokinetic study. The patients are pediatric subjects with treatment-resistant seizures, where cannabinoids show promise in helping out.
“Rapid advancement of our pharmaceutical CBD program is a key priority for Insys; this first in patient dosing with our pharmaceutical CBD formulation is a significant milestone,” said President & CEO Michael L. Babich. “Per the FDA’s request, our PK study is being conducted in epilepsy patients. This will enable us to gain early insight on the safety and tolerability of our CBD candidate in epileptic children.”
The clinical trial will evaluate multiple ascending doses of the company’s oral cannabinoid (“CBD”) solution at three different dosage strengths. With multiple study centers across the U.S., the company expects that its new DEA-inspected facility in Texas will be capable of manufacturing ample quantities of CBD for its research and commercial plans over the coming years.
CBD is one of at least 60 active cannabinoids identified in the cannabis plant, which has a wider scope of medical applications than THC, and appears to have anti-convulsive action in animal models. The company CBD solution is 99.5% pure and synthesized to be chemically identical to the CBD extracted from cannabis. The FDA issued a master drug file for its CBD active ingredient in May 2014.
Dravet Syndrome – or childhood epilepsy – 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 seizures begin to emerge. Lennox-Gastaut syndrome is another form of severe childhood epilepsy that beings at between two and six years of page. The company aims to address both of these conditions.
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