DEA Adds an Oral THC Spray to Schedule II

Insys Therapeutics Inc, the same company that was associated with the marijuana legalization campaign in 2016, pushed the FDA to examine and approve the medical use of their oral cannabinoid solution. The FDA approved the drug, delta-9-THC, under the Insys label “Syndros” in 2016. Now, as of mid-2017, the DEA, acting under the recommendation of the HHS and and suggestion from the FDA, placed the drug into Schedule II of the Controlled Substances Act. This decision sparked controversy.

The most commonly referenced controversial element of the entire ordeal spawned region a decision made by the pharmaceutical company in 2016. Amidst the 2016 election, the Arizonans for Responsible Drug Policy fought a ballot measure that would have legalized marijuana. Recreational marijuana. Insys Therapeutics funded roughly 10 percent of the money raised by the campaign against recreational marijuana. According to Newsweek, they fought the legalization to “protect the safety of Arizona’s citizens, and particularly its children.

This rang alarm bells for many, even back then. Insys Therapeutics created a fentanyl oral solution that killed pain just as would any strong painkiller. Theorists all over the United States have long believed that large pharmaceutical companies fought against marijuana. The argument is that marijuana provides pain relief and therefore companies that make pain relief medications would take a financial hit.

That leads to the second conclusion; Insys Therapeutics donation to the fight against legal recreational marijuana convinced many of this theory. And the belief that the DEA and the same pharmaceutical companies work together, in an under-the-table fashion, is not uncommon. So the legalization of Insys Therapeutics oral delta-9-THC solution shook the way some (search Google for the DEA and Insys) felt about pharmaceutical companies, the DEA, and the US Attorney’s upcoming plans for marijuana.

JDSUPRA Business Advisor outlined the question:

“So what does this mean for the exploding growth of the cannabis industry? Some would say that the Schedule II classification is a step backward by the federal agencies in recognizing the medical value of cannabis. Others would argue that this is reflective of the current U.S. Attorney’s position on the legalization of cannabis. Regardless, the Schedule II designation may make it more difficult for cannabis-containing drugs to achieve the market penetration the sponsors of those drugs desire. In addition, the real question is whether this will have a chilling effect on research and development of additional cannabis pharmaceuticals.”

The DEA and FDA appear to hold the belief that marijuana and specifically dronabinol have a high abuse potential. However, the DEA acknowledged that current dronabinol products on the market provided some health benefit, per FDA approval. And similarly, justifying the Schedule II classification, the DEA noted a severe dependency status associated with dronabinol products. The other dronabinol product, Marinol, recently dropped to schedule III where prescribers can write refills.

And although the dronabinol, or delta-9-THC, in both Marinol and Syndros is “synthetic” in the sense that it did not come out of the ground, the media’s current comparison lacks validity. According to the FDA themselves, dronabinol is the main component in marijuana. The similarity to any drugs that fit the classic portrayal of “spice” start and stop with the word synthetic any shared—mainly peripheral—feelings. “Dronabinol is a generic name for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC). THC is the primary psychoactive substance in marijuana. Dronabinol is the active pharmaceutical ingredient in Syndros,” the DEA wrote in the Interim final rule.