A troubled pharmaceutical company known for making the powerful painkiller fentanyl just took one step closer to getting into the legal marijuana business — with help from the DEA.
InSys Therapeutics, the Arizona-based manufacturer of the fentanyl spray Subsys, has been developing a new product called Syndros, which is a liquid that contains a synthetic version of delta-9-THC, the ingredient in marijuana that makes users feel high.
Syndros has already received approval from the Food and Drug Administration (FDA), and the DEA announced on March 23 that the product will be classified as a Schedule II controlled substance, a less restrictive category of drugs than actual weed. Marijuana is currently list alongside heroin in the Schedule I category, a status reserved for dangerous drugs that have “no accepted medical use” and “high potential for abuse.”
Researchers and activists have long sought to have marijuana removed from the Schedule I category, arguing that it has many medical applications and no risk of causing fatal overdoses. The DEA rejected two requests to reschedule marijuana last year.
The DEA’s announcement about Syndros in the Federal Register notes that the drug has “high potential for abuse,” and puts users at “an increased risk of experiencing serious adverse events,” which “may potentially result in an overdose.”
A DEA spokesman referred questions about the scheduling decision to the FDA, which did not immediately respond to a request for comment. The FDA and Department of Health and Human Services provide drug scheduling recommendations to the DEA, which makes the final decision based on analysis provided by the two agencies.
Syndros has been approved as a treatment for AIDS and cancer patients who are struggling to eat because of their condition. Doctors in states that allow medical marijuana commonly prescribe the edible and smokable forms of weed to stimulate appetite and quell nausea.
InSys donated $500,000 last year to the successful campaign to defeat a marijuana legalization ballot initiative last year in Arizona. The company said it opposed the measure because it “fails to protect the safety of Arizona’s citizens, and particularly its children.”
In December, the ex-CEO of InSys and six other former top executives were arrested and accused of bribing doctors, defrauding insurance companies, and fueling America’s opioid crisis. Federal prosecutors in Massachusetts say the company paid hundreds of thousands of dollars worth of bribes and kickbacks to doctors who operated pain clinics in exchange for the physicians prescribing the company’s fentanyl spray to non-cancer patients. They pleaded not guilty and a trial date has not been set.
The company’s stock plummeted after the arrests late last year, but rebounded last week after the DEA’s scheduling announcement, with one analyst calling it “the best marijuana stock on the market right now.”