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Synthetic THC drug Syndros poised for Schedule II classification

Insys Therapeutics could launch its liquid dronabinol drug Syndros later this year

A synthetic THC drug just cleared a federal regulatory hurdle to commercialization.

Insys Therapeutics, a Chandler, Ariz.-based pharmaceutical firm, said Thursday its U.S. Food and Drug Administration-approved liquid dronabinol drug Syndros could launch later this year after the synthetic THC oral solution received an initial go-ahead for Schedule II classification under the Controlled Substances Act, which would allow doctors to prescribe it.

“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.”

The U.S. Drug Enforcement Administration posted an interim final rule to the Federal Register placing “FDA-approved products of oral solutions containing dronabinol” in Schedule II, the second-most restrictive category. Other drugs in Schedule II — classified as substances with a “high potential for abuse” but having some form of currently accepted medical use — include Vicodin, cocaine, oxycodone, Adderall and Ritalin. Marijuana is classified in Schedule I.

The FDA approved Insys’ New Drug Application for Syndros in July 2016. Company officials anticipated that Syndros, a liquid reformulation of the dronabinol pill Marinol, would receive at least a Schedule II designation.

Marinol, FDA-approved in 1985, is formulated in sesame oil and encapsulated in a soft gelatin capsule. It is regulated as a less-restricted Schedule III substance.

Health and Human Services officials said that liquid dronabinol has a higher potential for abuse than Marinol because the liquid formulation could be manipulated to produce extracts for vaping or edibles, according to the notice in the Federal Register.

Vetticaden last year told The Cannabist that chemically synthesized drugs are highly reliable and thus could meet the rigorous testing demands and standards from the FDA. A synthetic approach could mitigate any potency issues that patients could encounter when buying products from dispensaries.

Insys, in regulatory filings to the U.S. Securities and Exchange Commission, has expressed concerns about “natural cannabis” and the legalization of marijuana:

Moreover, our cannabinoid products may compete with non-synthetic cannabinoid drugs, including therapies such as GW Pharmaceuticals’ Sativex and Epidiolex, especially in many countries outside of the United States where non-synthetic cannabinoids are legal. In addition, literature has been published arguing the benefits of natural cannabis, or marijuana, over dronabinol, and there are a number of states that have already enacted laws legalizing medicinal and recreational marijuana. There is some support in the United States for further legalization of marijuana. We also cannot assess the extent to which patients utilize marijuana illegally to alleviate (Chemotherapy-Induced Nausea and Vomiting), instead of using prescribed therapies such as approved dronabinol products.

Last fall, Insys contributed $500,000 to the campaign against marijuana legalization in Arizona.

Insys officials could not be reached Thursday for additional comment.

The approval is a dash of positive news for Insys, which is facing a barrage of investigations, lawsuits and enforcement actions related to its Subsys fentanyl spray, said Ken Trbovich, an analyst who covers Insys for financial services firm Janney Montgomery Scott. Trbovich does not have any investments in Insys securities. Janney Montgomery Scott intends to receive compensation for investment banking services from Insys, according to disclosures made in Trbovich’s research report from March 16.

Insys was 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.

The scheduling of Syndros could alleviate some concern from investors that the Subsys actions would hang like a cloud over the future pipeline of the company, Trbovich said.

The DEA’s interim rule became effective Thursday and is now in a 30-day comment period.