Posted by Michael Wonder on 05 Jul 2016
FDA approves treatment for AIDS symptoms
5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014.
Insys Therapeutics Inc. said Tuesday that the U.S. FDA approved its Dronabinol oral solution for treating certain conditions related to cancer and AIDS, nearly two years after the regulator rejected an earlier application.
The drug, Syndros, is approved for treating anorexia associated with weight loss in patients with AIDS as well as nausea and vomiting associated with cancer chemotherapy in patients who haven't responded to conventional treatments. Syndros is an orally administered liquid formulation of dronabinol.
In October 2014, the FDA rejected the company’s Dronabinol oral solution, and the company said in June 2015 that it resubmitted a new drug application to the regulator. In April, the company’s shares dove after it said first-quarter sales of its flagship product, the cancer-pain treatment Subsys, were well below analyst expectations.
