Insys Soars on Huge FDA Win

Insys Therapeutics Inc. (NASDAQ: INSY) shares made a leap early on Tuesday following a key U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA has approved its dronabinol oral solution, Syndros, for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

At the same time, Insys also announced that Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration. The company expects to launch Syndros in the second half of 2016.

For some background: Syndros is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC).

Roughly 9,500 prescribers account for 70% of current dronabinol prescriptions. Insys expects to convert a large portion of the market to Syndros, as well as expand the market through direct detailing to physicians, highlighting the improved product profile of Syndros.

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Dr. John N. Kapoor, chairman, CEO and president, commented:

We are very pleased to announce FDA approval of Syndros. We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS.

He added:

Syndros is the first and only FDA approved dronabinol solution for oral use.  It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect.  Once Syndros has been opened, it does not need to be refrigerated for 28 days.  We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth. We expect that Syndros’ attractive profile will enable rapid market conversion and expansion, making for a significant long-term commercial opportunity for Insys.

Shares of Insys closed Friday up 4% at $13.47, with a consensus analyst price target of $24.40 and a 52-week trading range of $11.45 to $46.17. Following the release of the earnings report, the stock was up about 15% at $15.50 in early trading indications Tuesday.

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