While most of the country was preparing to get high on some Thanksgiving turkey last week, the Drug Enforcement Agency (DEA) quietly granted a Schedule II classification to the drug Dronabinol, a synthetic THC nasal spray. The classification means the government officially recognizes its medicinal potential and will allow it to be prescribed, sold and federally regulated.
Non-synthetic THC, which is the active chemical compound in marijuana, remains classified as a Schedule I drug. As such, the government believes it is potentially dangerous and has no medicinal value.
Insys Therapeutics, the company which developed Dronabinol, will now enjoy a monopoly on the treatment of cancer patients who experience nausea from chemotherapy thanks to the DEA.
“It should be noted as a preliminary matter that any form of dronabinol other than in an FDA-approved drug product remains a schedule I controlled substance, and those who handle such material remain subject to the regulatory controls, and administrative, civil, and criminal sanctions, applicable to schedule I controlled substances set forth in the CSA and DEA regulations.”
With Insys facing no competition in the market, they will price the medication between $1,000 to $2,000 per month.
All of this comes after years of well documented legal maneuvering and market manipulation by the pharmaceutical firm.
Last year Insys spent $500,000 to stop Arizona's recreational cannabis measure. They argued that pot businesses would be bad for public health and endanger children. Less than five months after defeating the legalization effort, they announced to shareholders that the DEA had given them approval to launch Syndros, the market name for Dronabinol.
Insys also happens to manufacture fentanyl, a painkiller that is 50 times stronger than heroin and is driving the national opioid crisis. Six former Insys executives were recently arrested for bribing doctors to prescribe fentanyl to patients who didn’t need it, including Insys founder Dr. John N. Kapoor, who stepped down after the charges were filed.
“I am confident that I have committed no crimes and believe I will be fully vindicated after the trail,” Kapoor said in his resignation letter.
That product is a Transmucosal Immediate Release Fentanyl known as Subsys which was meant to treat cancer patients, but prescribed widely to those who did not have cancer.
Insys is now working on a synthetic version of Cannabidiol to treat a variety of ailments in children. That substance, which is also an oral solution, is currently in various stages of clinical trials in the FDA’s approval process.