FDA Approves Pharmaceutical Cannabinoid for Disease-Related Anorexia

The FDA has approved Insys Therapeutics Inc’s oral solution, Syndros, which is a liquid formulation of the pharmaceutical cannabinoid dronabinol.

Syndros may be used in patients experiencing anorexia due to AIDS, as well as cancer patients experiencing nausea and vomiting due to chemotherapy, and have not responded adequately to traditional antiemetic treatments.

"We are very pleased to announce FDA approval of Syndros,” said John N. Kapoor, company chairman, CEO, and president, in a press release. “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.”

The most common adverse effects associated with Syndros are dizziness, drowsiness, and nausea. However, some other rare adverse effects have also been reported, including abdominal pain, restlessness, itching eyes, cough, and diarrhea.

“Syndros is the first and only FDA approved dronabinol solution for oral use,” Syndros stated in a press release. “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.”

Insys Therapeutics expects to launch the drug in the second half of 2016. Syndros has yet to be scheduled by the Drug Enforcement Administration.