Where does FDA approval for the first psychedelic drug stand?

The FDA is set to make a decision on what could be the first psychedelic drug to receive agency approval by August 11, according to Amy Emerson, CEO of Lykos Therapeutics, which developed the MDMA-based drug.

The drug is designed for the roughly 13 million US adults with post-traumatic stress disorder (PTSD) and would be the first new FDA-approved drug to treat the disorder in more than two decades, Healthcare Brew previously reported. Patients would receive the drug along with three eight-hour therapy sessions, three to five weeks apart, in addition to 12 drug-free therapy sessions.

Lykos Therapeutics, which changed its name from MAPS Public Benefit Corporation in January, submitted a new drug application to the FDA for the MDMA therapy in December 2023. In February, the FDA accepted the application and granted it priority review, meaning the agency’s goal is to approve or deny it within six months rather than the standard 10 months, Emerson said.

The FDA declined to comment.

Assuming the FDA approves the MDMA drug, Emerson said there are a number of steps that need to be taken before physicians would be able to access it.

“If FDA-approved, we will focus on the integration of psychedelic-assisted therapy into the healthcare system with a controlled, quality-focused launch,” she said.

First, the US Drug Enforcement Administration (DEA) would be required to reschedule MDMA from a Schedule 1 drug within three months of the drug’s approval, according to Emerson. A Schedule 1 drug has “no currently accepted medical use and a high potential for abuse,” according to the DEA. After federal rescheduling, states would then be required to reschedule the drug—a process that varies by state, she said.

Clinicians would also need some training to learn best practices for MDMA-assisted therapy, Emerson added.

Emerson said she expects there to be a “limited availability of MDMA-assisted therapy initially.”

“Our plan is to make MDMA-assisted therapy available—if approved in August—in the new year,” she said.

Until the FDA makes a decision, Lykos is focused on working with the agency during the application review process, Emerson said. The company is also preparing for a potential commercial launch.

“There is still a lot of work to do,” Emerson said.

Lykos recently received a big boost to help it with that work, announcing that it had closed a $100 million Series A funding round in January. Emerson said Lykos will use the money to “support the development and pre-launch activities associated with MDMA-assisted therapy for PTSD.”