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Drug Discovery and Development

Senators Booker and Paul aim to reschedule psilocybin and MDMA to foster research

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Cory Booker and Rand Paul

Cory Booker and Rand Paul [Images courtesy of Senate.gov]

U.S. Senators Cory Booker (D-N.J.) and Rand Paul (R-KY) have drafted the Breakthrough Therapies Act, which would enable the Drug Enforcement Agency (DEA) to research rescheduling Schedule I drugs such as psilocybin and MDMA to Schedule II.

Rescheduling would make it easier for pharmaceutical companies to investigate the therapeutic potential of psilocybin and MDMA.

An aim to facilitate research

“Unfortunately, regulatory red tape and a series of bureaucratic hurdles involved in studying Schedule I substances impedes critical research on these and other promising Schedule I compounds,” said Senator Booker in a news release. “This bill reduces these unreasonably burdensome rules and regulations that delay or prevent researchers from studying – and patients from accessing – this entire class of potential medicines.”

“This bill will make it easier for researchers to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions,” Senator Paul said in a statement.

The text from the Breakthrough Therapies Act is posted on Senator Booker’s site.

DEA deems Schedule I drug to have no currently accepted medical use and a high abuse potential. Schedule II drugs have a high abuse potential but therapeutic potential. Examples of Schedule II drugs include Vicodin with less than 15 mg of hydrocodone, cocaine, methamphetamine, oxycodone (OxyContin), fentanyl, Adderall, and Ritalin

FDA has granted breakthrough therapy designation to both psilocybin and MDMA.

Inching toward FDA approval?

Psilocybin and MDMA have both been the subject of numerous clinical studies.

Multidisciplinary Association for Psychedelic Studies (MAPS) recently announced the completion of a Phase 3 study of MDMA for post-traumatic stress disorder (PTSD). The organization expects top-line results in the first quarter of 2023. The study was the second of two Phase 3 pivotal studies that will be the basis for the New Drug Application (NDA).

In October, Compass Pathways (Nasdaq:CMPS) announced that it planned to launch a Phase 3 study of psilocybin for treatment-resistant depression by the end of the year. It will be the first Phase 3 study of psilocybin.

FDA could possibly approve psilocybin and MDMA for mental health disorders in the next few years.

Filed Under: Psychiatric/psychotropic drugs
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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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