A new synthetic marijuana drug has just been approved by the U.S. Drug Enforcement Agency (DEA). Syndros, created by pharmaceutical company Insys Therapeutics, is a synthetic formulation of THC, the chemical responsible for the psychoactive effect of the cannabis plant.
The approval by the DEA classifies Syndros as a Schedule II drug under the federal Controlled Substances Act (CSA). According to the Schedule II definition, any drug in this category has a significant probability of abuse but also has some “therapeutic benefits.” This group puts synthetic marijuana and any generic formulations alongside other drugs like cocaine, morphine, and most prescription painkillers.
DEA Approves Syndros, a Pharma Cannabis Solution, for Schedule II Status
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The synthetic marijuana drug was approved by the Food and Drug Administration (FDA) last year to treat nausea, vomiting, and weight loss related to cancer and AIDS.
“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, as cited by The Cannabist. “We look forward to interacting with the FDA to finalize the labeling and subsequent launch of Syndros in the second half of 2017.”
The synthetic marijuana drug is a liquid version of the pill-form drug named Marinol, which received FDA approval over 20 years ago. Both drugs are made using tetrahydrocannabinol (THC), which is derived from the cannabis plant. Some health authorities fear Syndros may have a higher potential for abuse than Marinol as the synthetic marijuana liquid can be altered to make extracts for vaping. Marinol is considered a Schedule III drug under CSA.
Insys Therapeutics has been an active player in the fight against marijuana legalization. In 2011, pointing out the potential for abuse of legally grown marijuana plants in the U.S., the company asked the DEA to keep tight restrictions on naturally derived THC. Last year, another letter was sent to the DEA asking the agency to relax regulations on synthetic versions of CBD, another chemical found in weed. Meanwhile, Insys is actively researching another new drug based on CBD that can help treat children with epilepsy.
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In a deliberate attempt to thwart marijuana legalization in Arizona, Insys donated $500,000 to an organization opposed to legal cannabis, Arizonans for Responsible Drug Policy. The contribution helped the group lead a successful campaign to stop legalization of weed in the state. According to a September Washington Post report, the company’s endowment was the largest to any previous anti-legalization campaign ever.
“It appears they are trying to kill a non-pharmaceutical market for marijuana in order to line their own pockets,” said J.P. Holyoak, an active supporter of a campaign to legalize cannabis in Arizona, according to the same Washington Post article.
Insys defended its position by arguing any marijuana legalization laws jeopardize public safety, particularly children. However, the Chandler, Arizona-based company did mention the potential medical benefits of cannabinoids, while insisting synthetic marijuana products are safe to use with quality developing, thorough testing, and proper manufacturing.
Currently, Insys has legal trouble with several states as well as the federal government for using overly-aggressive marketing tactics to promote Subsys, a product containing the opioid painkiller fentanyl. Late last year, the pharmaceutical firm’s former CEO and five other executives were arrested by the FBI for fraud and illegal kickbacks related to selling “a highly potent and addictive opioid.”
Insys initially submitted paperwork seeking FDA approval of the synthetic marijuana drug in August 2014, but several setbacks delayed the agency’s action. At the same time, the company asked the DEA to classify the drug as Schedule IV, claiming it has a low risk for abuse or dependence. However, the DEA ultimately decided on the Schedule II description.
Insys has high expectations for its synthetic marijuana drug Syndros. The company has hired over 200 salespeople to market the product and predicts to make $200 million in annual sales. Meanwhile, whole-plant marijuana remains illegal under federal law, being listed as a Schedule I drug under CSA right alongside other drugs like heroin and ecstasy.
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