This article was originally published on Microdose and appears here with permission.
The stigma against psychedelics might appear to be fading, with psychedelic startups attracting billions of dollars of investment and the U.S. Food and Drug Administration (FDA) actively encouraging research into psilocybin and MDMA. But the war on psychedelic drugs is still alive and well over at the federal Drug Enforcement Agency (DEA).
The DEA announced earlier this month that they plan to add five more psychedelic drugs to the Controlled Substance Act, including at least one drug that is showing promise as a treatment for postpartum depression and treatment resistant depression.
Despite their medical potential, the DEA wants to add the drugs to Schedule 1 of the Controlled Substance Act, the most restrictive legal class of drugs that is reserved for substances with a high potential for abuse and no currently accepted medical use. The five compounds, all tryptamines, are:
- 4-Hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT),
- 5-Methoxy-alphamethyltryptamine (5-MeO-AMT),
- N-Isopropyl-5-Methoxy-N-Methyltryptamine (5-MeO-MiPT),
- N,N-Diethyl-5-methoxytryptamine (5-MeO-DET), and
- N,N-Diisopropyltryptamine (DiPT).
Ironically, these drugs are already illegal when used recreationally for human consumption because of the Federal Analogue Act, according to Matt Zorn, an attorney at Yetter Coleman. But the Analogue Act does not prevent American researchers from handling the compounds, so it’s currently relatively easy for American scientists to study these five drugs.
However, if the DEA follows through on the scheduling researchers will need approval from the agency to continue their research. DEA approval is an expensive and lengthy process that can stretch on for years. The scheduling would also allow the DEA to set production quotas on manufacturing of these tryptamines. DEA production quotas have historically hindered research into drugs like cannabis.
Zorn said the DEA action will primarily affect American scientists studying these compounds.
“The researchers working with these compounds are probably the members of the population most adversely affected,” Zorn said in an email.
The five obscure tryptamines are mostly unknown outside of psychonaut and psychedelic research communities. The most recognizable on the list is 4-HO-DiPT (the DEA refers to it as 4-OH-DiPT, a naming convention not followed by most scientists), a synthetic psychedelic that is noteworthy for its strong effects yet short trip duration. Noted psychopharmacologist (and inventor of 2-CB) Alexander Shulgin said it was unmatched among other orally active psychedelics for its speed, intensity, and brevity. These traits make 4-HO-DiPT an attractive psychedelic for use in therapeutic settings.
Psychedelic medicine start-up Field Trip Health is already pursuing FDA approval for its own proprietary version of a 4-HO-DiPT prodrug, expecting to start a Phase I trial on the drug sometime this year. The FDA had previously told Field Trip that the company’s prodrug, called FT-104, was not a controlled substance.
Field Trip did not return a request for comment but it appears that the DEA’s scheduling of these five tryptamines, if it becomes finalized, will harm American researchers far more than Canadian-based companies like Field Trip. Canada does not consider these drugs to be a controlled substance so manufacturing the drug and running clinical trials will continue to be relatively straightforward in Canada.
But for American researchers, the DEA action will make researching these drugs far more expensive and cumbersome. David Heldreth, Chief Executive Officer of Panacea Plant Sciences, said that his Washington-based biotechnology is actively researching these five compounds and had asked the DEA in December to clarify if the compounds were a controlled substance. Panacea is working with Egret Biosciences in British Columbia and wanted to start importing and exporting the compounds across the international border.
Heldreth said if the DEA moves ahead with scheduling these tryptamines the two companies will no longer research these compounds inside the United States.
“We would just conduct all of the work for those items in other countries, until we got to a certain stage and then we would seek approval here,” Heldreth said. “It will be science that will be conducted and revenue that will be made for other countries besides the United States. And I’m an American so I would like that to happen here.”
The public has until Feb. 14 to submit comments regarding the DEA’s rulemaking plans. The agency itself will ultimately get to decide on whether or not to proceed with the scheduling, according to Zorn.
“[The] DEA is the final arbiter of when the rule gets finalized,” Zorn said. “Not sure I can say much beyond that now, but there are a few ways this could shake out.”
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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