Written by Robert J. Hilton, Ph.D. and Jason J. Jardine

On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016 for use in treating anorexia associated with weight loss in patients with AIDS and for treating chemotherapy induced nausea and vomiting (CINV) associated with cancer chemotherapy in patients who fail to respond to conventional antiemetic treatments. However, at that time, the U.S. Drug Enforcement Agency (DEA) had not yet designated a schedule for the product. Syndros™ is the first FDA approved dronabinol solution for oral use. The label approval represents the final regulatory step for moving the oral dronabinol solution to market.

For anorexia associated with weight loss in AIDS patients, which affects 7-8% of AIDS patients, the Syndros™ label provides a starting dosage of 2.1 mg orally twice daily to a maximum dosage of 8.4 mg twice daily. For CINV associated with chemotherapy treatments, the label recommends a starting dosage of 4.2 mg per patient body surface area (BSA) in m2 administered orally 1-3 hours prior to chemotherapy treatment and then administered 2 to 4 hours after chemotherapy treatment for 4 to 6 doses per day.

Dronabinol, or tetrahydrocannabinol (THC), is the primary active ingredient in the controlled substance marijuana. Cannabinoids, including dronabinol are insoluble in water. According to Insys Therapeutics, Inc., Syndros is the first and only oral dronabinol solution, and provides advantages over current soft gel capsule formulations, including easy-to-swallow dosages and no requirement for refrigeration. Syndros™ is associated with its rights in U.S. Patents 8,628,796, 8,222,292, and 9,345,771.

According to its website, Insys Therapeutics, Inc., is a Phoenix, Arizona-based commercial-stage specialty pharmaceutical company that develops and commercializes innovative supportive care and therapeutic products.