Australia reclassifies psychedelics to facilitate medical use, as advocates push for similar move in US

Australia’s Therapeutic Goods Administration (TGA) has reclassified two psychedelic substances to facilitate their use as medicines for certain mental health conditions, a move that some advocates say could serve as an example for the US.

Australia announced in February that starting July 1, authorized psychiatrists can prescribe drugs containing psilocybin, an active substance in “magic mushrooms,” and MDMA for treatment-resistant depression and post-traumatic stress disorder, respectively. Those are the only two conditions for which TGA has said there is “currently sufficient evidence for potential benefits.”

Psilocybin and MDMA will be reclassified as Schedule 8, or controlled drugs, for those uses and remain as Schedule 9-prohibited substances in all other circumstances.

While there are currently no TGA-approved medicines containing psilocybin or MDMA, the agency said these changes will “allow authorised psychiatrists to access and legally supply a specified ‘unapproved’ medicine containing these substances to patients under their care for these specific uses.”

Psilocybin is currently under development by a variety of companies for conditions such as PTSD and treatment-resistant depression, while MDMA has been similarly studied in PTSD and anxiety in terminally ill patients.

In the US, a suite of activists, drugmakers and policymakers has advocated for the reclassification of psilocybin and MDMA, which are currently Schedule I substances, meaning they have “no currently accepted medical use and a high potential for abuse.” The Controlled Substances Act was enacted in 1970 separating substances into five schedules, with Schedule I being the most serious.

Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced a bill in November which would allow the federal Drug Enforcement Administration to make the necessary findings to reclassify therapies such as MDMA or psilocybin as Schedule II drugs, which are still characterized as having a high risk of abuse, though they include medicines such as OxyContin and Dilaudid.

When it comes to clinical trial design, MindMed CEO Robert Barrow said controlled substance regulations impose “an additional barrier on top of an already extremely rigorous process.” His company’s lead product, a pharmacologically optimized formation of LSD, is currently in a Phase IIb trial for generalized anxiety disorder.

“I think there’s a very different, clear distinction between rescheduling a drug in order to facilitate its use and rescheduling it to facilitate its clinical research,” he said.

Reclassifying certain therapies that contain Schedule I substances would “help facilitate a phased rollout of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs,” the senators said in November, and remove “regulatory red tape and a series of bureaucratic hurdles,” Booker added.

Sunil Aggarwal

Seattle doctor and University of Washington professor Sunil Aggarwal took the fight to change psilocybin’s CSA status to federal court last year. When he previously asked the DEA to reclassify psilocybin as a Schedule II substance, the agency responded that the FDA “has not articulated any accepted medical use” for the drug. In October, he petitioned the Ninth Circuit Court of Appeals to review the DEA’s decision, which remains ongoing.

“It’s just onerous,” Aggarwal told Endpoints News on Wednesday. “You can manage diversion and all those things without all that, just the same way we do with THC pills, which is Schedule III, or ketamine, which is Schedule III.”

Two weeks ago, the FDA released new draft guidance on conducting clinical research with psychedelics such as psilocybin, which acknowledged that designing clinical studies to evaluate their safety and efficacy “presents several unique challenges.”

Read More