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.