Insys Therapeutics, Inc. announced that it has successfully completed a human abuse study on dronabinol oral solution, a liquid formulation of the synthetic cannabinoid dronabinol.
Insys conducted the human abuse study as per the requirements of the U.S. Drug Enforcement Agency for classification purposes.
Insys completed the clinical study as required for the New Drug Application (NDA) filing during the third quarter of 2013. Earlier, Insys completed a pre-NDA meeting with the FDA and a pivotal bioequivalence study for the dronabinol oral solution in 2012.
Insys now expects to file the NDA in the third quarter of 2014.
We remind investors that Insys received FDA approval for dronabinol capsules, a generic equivalent of Marinol, an approved second-line treatment for chemotherapy induced nausea and vomiting (CINV) and anorexia associated with weight loss in AIDS patients in Aug 2011.
The oral solution is expected to lead to faster onset of action along with better dosage flexibility as compared to capsules.
Insys has an exclusive supply and distribution agreement with Mylan, Inc. whereby Mylan holds the right to distribute dronabinol capsules in the U.S.
Last week, Insys announced that the FDA has granted orphan drug status to its epilepsy candidate, pharmaceutical cannabidiol, for treating Dravet syndrome, a rare form of intractable epilepsy that commences in infancy.
Insys carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader healthcare sector include Allergan and AbbVie . Both stocks carry a Zacks Rank #2 (Buy).