DEA rule would classify Syndros drug as controlled substance

An interim final rule introduced by the Drug Enforcement Agency would result in Insys Therapeutics Inc.'s Syndros product being placed in Schedule II of the Controlled Substances Act.
The U.S. Food and Drug Administration approved a New Drug Application for Syndros on July 1, 2016. The product is a cannabinoid that can be used to help treat anorexia in patients with AIDS as well as nausea and vomiting associated with cancer chemotherapy.
“Insys is looking forward to bringing this new drug product to chemotherapy patients to help alleviate their nausea and vomiting and AIDS patients with anorexia associated weight loss, respectively,” interim CEO and Chief Medical Officer Dr. Santosh Vetticaden said in a statement. “We look forward to interacting with the FDA to finalize the labeling and subsequent launch of Syndros in the second half of 2017.”
Insys Therapeutics, a specialty pharmaceutical company, specializes in helping improve the quality of life for patients by utilizing innovative drugs and novel drug delivery systems of therapeutic molecules. The company is using proprietary sublingual spray technology to bring pharmaceutical cannabinoids to market.