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DEA finalizing Schedule II status for synthetic THC drug Syndros

The U.S. Drug Enforcement Administration this week will grant Schedule II status to a synthetic THC drug developed by a pharmaceutical firm beset with controversy.

The DEA on Wednesday is expected to finalize the previously suggested Schedule II status for Syndros, the FDA-approved liquid dronabinol drug developed by Insys Therapeutics, the Chandler, Ariz.-based pharmaceutical company that last year donated to a campaign opposing marijuana legalization and last month saw its founder arrested on fraud and racketeering charges.

John Kapoor and other executives were accused of providing kickbacks to doctors to prescribe the company’s Subsys fentanyl spray, a highly addictive and potentially deadly opioid painkiller. Prior to Kapoor’s arrest, Insys was party to several investigations, lawsuits and enforcement actions related to Subsys.

Syndros’ advancement, approval and scheduling have been viewed by analysts as potentially positive developments for the firm.

Insys launched Syndros in late July as a treatment to help alleviate nausea and vomiting in chemotherapy patients and to address anorexia-associated weight loss in AIDS patients. Syndros generated $700,000 in revenue during the first two months, company officials said earlier this month.

The U.S. Food and Drug Administration approved the new drug application for Syndros and, alongside the Department of Health and Human Services, provided a scheduling recommendation for the drug. DEA officials concurred, noting that the drug would have the same abuse potential as other substances classified as Schedule II, according to the preliminary, “unpublished,” filing made Tuesday in the Federal Register.

Schedule II substances include Vicodin, cocaine, oxycodone and Adderall.

In the final rule filing, the DEA noted that four comments were submitted in support of the Schedule II listing while four comments were submitted in opposition.

Of the latter, one indicated the dichotomy between Syndros garnering Schedule II status while marijuana remained in the stricter classification of Schedule I. Two commenters expressed concern that pharmaceutical firms were profiting from approved drugs containing marijuana constituents and another commenter noted that the FDA should not approve drug containing any constituents of marijuana.

“The DEA notes that FDA-approved products of oral solutions containing dronabinol have an approved medical use, whereas marijuana does not have an approved medical use and therefore remains in Schedule I,” DEA officials wrote in the filing.

Marijuana advocates have blasted Insys for its stance opposing cannabis legalization. The company donated $500,000 to the campaign against marijuana legalization in Arizona and has expressed concerns about “natural cannabis” and the legalization of marijuana in regulatory filings.

Company officials previously have told The Cannabist that synthetic drugs are highly reliable and consistent and can meet the rigorous demands of the FDA process and subsequent commercialization.

Insys officials were not immediately available early Tuesday morning to respond to The Cannabist’s before-hours request for comment.