On Thursday, Insys Therapeutics announced that the Drug Enforcement Administration (DEA) issued an interim final rule that would put Syndros, their synthetic marijuana drug, on Schedule II of the Controlled Substances Act (CSA).
“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,” Dr. Santosh Vetticaden, interim CEO, said in the announcement.
“We look forward to interacting with the FDA to finalize the labeling and subsequent launch of Syndros in the second half of 2017,” Vetticaden said.
Syndros is a synthetic version of tetrahydrocannabinol (THC), the main psychoactive component in the plant. In July 206, the company announced the FDA approved their liquid form of synthetic THC to treat anorexia associated AIDS patients, and nausea and vomiting induced by cancer patients going through chemotherapy.
The DEA approval placed Syndros and its generic formulations in schedule II of the CSA, which is reserved for drugs that have “a high potential for abuse, with use potentially leading to severe psychological or physical dependence.”
While some Schedule II drugs can be used for medical purposes, like Vicodin, oxycodone, Adderall, and many prescription painkillers, Schedule I drugs are all federally illegal. Non-synthetic marijuana is a Schedule I drug, which is reserved for drugs that have “no currently accepted medical use and a high potential for abuse.”
In 2011, Insys wrote a letter to the DEA, urging them to maintain the Schedule I status for non-synthetic marijuana, citing “a longstanding policy of the United States to disfavor domestic cultivation of narcotic raw materials because of concerns about the abuse potential from farming of this material."
Insys also opposed legalization in Arizona, donating $500,000 to Arizonans for Responsible Drug Policy, a group opposing Proposition 205, an initiative to legalize and regulate marijuana like alcohol in Arizona.
In a statement, Insys said it opposed Prop 205, "because it fails to protect the safety of Arizona’s citizens, and particularly its children,” according to the Arizona Republic.
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