DEA Awards Synthetic Cannabis Drug with Schedule II Status

All cannabis in the United States is classified under Schedule I, the most restrictive classification possible under the Control Substances Act. A drug containing synthetic THC, however, was granted Schedule II status by the U.S. Drug Enforcement Agency. Schedule II status means that the drug can be prescribed by a doctor, but the drug is labeled for a high potential of abuse like painkillers or low amounts of cocaine or methamphetamine. The drug’s maker, a Chandler, Arizona-based pharmaceutical firm called Insys Therapeutics, waited two years for the DEA’s approval.  The liquid dronabinol drug Syndros could launch and become available in a pharmacy by later this year.

“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,” Insys interim CEO Dr. Santosh Vetticaden said in a written statement. We look forward to interacting with the FDA to finalize labeling and subsequent launch of Syndros in the second half of 2017.” The DEA’s interim final rule approves oral solutions containing dronabinol.

Other cannabis-based drugs have achieved Schedule III status, such as Marinol. Liquid dronabinol drugs like Syndros are classified in the more restrictive Schedule II because theoretically, they could be processed into hash or oil. This is great news for the drug maker, which is in hot water over a fentanyl spray Subsys, which it also manufactures. The company is also facing charges from Attorney General Joseph A. Foster over its drug Subsys. It’s notable that even though the drug maker Insys produces a synthetic cannabinoid drug, it has lobbied against cannabis legalization in its home state of Arizona. Legal, natural medical cannabis in Arizona is a direct competitor for companies like Insys. In some cases, there are other natural options and remedies that replace pharmaceutical drugs.