FDA moves to fast-track review of 3 psychedelic drug studies

The Food and Drug Administration (FDA) on Friday granted fast-track review to three companies studying psychedelic therapies to treat depression and post-traumatic stress disorder (PTSD), the latest step by the Trump administration toward possible approval. 

The agency did not disclose the specific companies that were granted priority review vouchers. Two companies are studying psilocybin; one for treatment-resistant depression (TRD) and the other for treatment of major depressive disorder. 

A third company is studying methylone, a drug similar to MDMA, for PTSD.  

“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,” FDA Commissioner Marty Makaray said in a statement. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.” 

Companies selected for the voucher program will be entitled to a shortened review time........

© The Hill