- The Drug Enforcement Agency has given a Schedule II classification to Insys Therapeutics' medication that uses synthetic compounds that mirror those found in cannabis plants.
- The Phoenix-based company announced the interim final ruling on Syndros (dronabinol) Thursday. While the Food and Drug Administration is responsible for determining a drug's safety and efficacy, the DEA gets the final say on its potential medical use or risk for abuse,
- Schedule II drugs are those that have "a high potential for abuse," but that also could have some therapeutic benefit, according to the DEA. Drugs in the class include cocaine, Shire's Adderall (amphetamine and dextroamphetamine salts) and AbbVie's Vicodin (hydrocodone bitartrate and acetaminophen). Notably, marijuana is currently classified as a Schedule I drug — deemed more dangerous than the higher schedules.
Syndros is a liquid, oral version of AbbVie's drug Marinol. Both drugs are synthetic versions of tetrahydrocannabinol, part of an active compounds group called cannabinoids that are found in marijuana plants. The FDA first approved Insys' drug last August as a treatment for AIDS-related anorexia and as an antiemetic for patients taking undergoing chemotherapy.
While Insys expected a Schedule II status for Syndros — and that status should help bypass some of the logistical and prescribing hurdles that intrinsically come from working with a Schedule I drug such as cannabis — it's not the best possible outcome. Marinol, for example, carries a Schedule III status.
The company initially requested in an August 2015 Citizen Petition that the DEA change Syndros' classification from Schedule I to Schedule IV, which would then characterize the drug as having a low risk for abuse or dependence. The petition not only failed to secure that lower scheduling, but additional information submitted by Insys as part of its rescheduling campaign led to the FDA pushing back Syndros' target action date.
The setback followed earlier issues with getting Syndros approved. Insys submitted a New Drug Application (NDA) for Syndros in August 2014, but a few months later was hit with a refuse to file from the FDA, which claimed the pediatric study plan for the drug was inadequate.
Despite the pitfalls, few cannabinoid products on are the market, meaning Insys will likely see solid returns for its drug. The company has already established a 200-member salesforce and expects Syndros to rake in at least $200 million in peak annual sales.