Dronabinol for Anorexia Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has approved the dronabinol oral solution, Syndros, of the pharmaceutical giant Insys Therapeutics.This approval comes nearly two years after the regulator had rejected its earlier application in 2014.

Syndros which is administered orally in a liquid form as opposed to the earlier soft gel capsule variety, is a formulation of cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC).

‘FDA approves Syndros,an orally administered liquid formulation of cannabinoid dronabinol, which is an appetite boosting drug used to treat anorexia associated with weight loss in AIDS as well as nausea and vomiting associated with cancer chemotherapy.’

Syndros is used to treat anorexia associated with weight loss in patients with AIDS as well as nausea and vomiting associated with cancer chemotherapy who have failed to respond to conventional treatments.

Insys Chairman and Chief Executive John N.Kapoor has said that the approval has made the drug the only dronabinol based product in the market that can be used orally. In a statement, he said, "We expect that Syndros' attarctive profile will enable rapid market conversion and expansion, making for a significant long-term commercial opportunity of Insys."

From a general disappointing performance in the stock market where stock had fallen 62% from a year ago, the shares of Insys Therapeutics are up 8.24% to $14.58 on heavy trading volume after receiving the FDA approval.

Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration and hopes to make its successful launch in the second half of 2016 and a sustained growth thereafter.

Source: Medindia