Insys Therapeutics, Inc
) announced that it has successfully completed a human abuse study
on dronabinol oral solution, a liquid formulation of the synthetic
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
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
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
) 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
). Both stocks carry a Zacks Rank #2 (Buy).
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