Insys Therapeutics Updates Timing Of Nda For Dronabinol Oral Solution – Yahoo Finance

“We are very excited about Oral Dronabinol Solution, which is the culmination of significant research and which we believe has distinct advantages over the current formulation of dronabinol in a soft gelatin capsule, including more consistent bioavailability, faster onset of action and more flexible dose,” said Michael L. Babich, President and Chief Executive Officer. Dronabinol is currently available only in a soft gelatin capsule form. According to Symphony Health Solutions, total prescriptions of Dronabinol grew 5% in 2013 as compared to 2012. While the capsule is available in only three strengths (2.5mg, 5 mg and 10 mg), Insys’ Dronabinol Oral Solution presents an opportunity for physicians to titrate more effectively. “Even though the Dronabinol capsule product is off-patent and has no promotion behind it, the Symphony Health Solutions data indicates growth in prescriptions. We believe this growth is a result of heightened awareness of medical marijuana, which may not be tolerable by certain patients and for which Dronabinol capsules offer an alternative.” Babich continued, “The many advantages of our Dronabinol Oral Solution should, assuming FDA approval, enable us to convert and expand this underserved market.” Insys is committed to Cannabinoid research and has an advanced manufacturing facility approved by FDA and DEA to produce pharmaceutical grade active pharmaceutical ingredient (API) Cannabinoids. Insys recently received Orphan Drug designation for its pharmaceutical Cannabidiol (CBD) candidate for Lennox-Gastaut Syndrome and Dravet Syndrome in pediatric populations, and is aggressively pursuing development of these indications. About Insys Therapeutics, Inc.
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