A synthetic marijuana drug could soon be available for commercialization after the Drug Enforcement Administration (DEA) approved Syndros, an oral remedy containing THC produced by the Insys Therapeutics, as schedule II classification.
Insys Therapeutics, a pharmaceutical company, on Thursday announced that the DEA has approved Syndros for Schedule II classification under the Controlled Substances Act, which would allow doctors to prescribe the drug.
“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 statement. “We look forward to interacting with the FDA to finalize the labeling and subsequent launch of Syndros in the second half of 2017.”
Syndros is a synthetic version of tetrahydrocannabinol (THC), the main psychoactive component in the marijuana plant. It was approved by the U.S. Food and Drug Administration (FDA) last summer to treat anorexia associated AIDS patients, and nausea and vomiting induced by cancer patients going through chemotherapy.
The FDA had also approved products containing dronabinol in an oral solution may lead to severe physical dependence. Based on the findings of the FDA, the DEA decided that Schedule II was an appropriate place for Dronabidiol, the active ingredient in Syndros .
The DEA approval places Syndros and its generic formulations in Schedule II of the Controlled Substances Act, indicating a “high potential for abuse.” Other Schedule II drugs include cocaine, morphine and many prescription painkillers.
Notably, Insys has been active in marijuana policy for several years. It contributed $500,000 last summer to Arizonans for Responsible Drug Policy, the group opposing marijuana legalization in Arizona.
Insys was previously accused of off-label marketing of the opioid painkiller and has faced allegations of providing kickbacks to doctors to prescribe the highly addictive and potentially deadly drug.