FDA approves NDA to determine safety, efficacy of psilocybin for OCD treatment

The FDA has approved an investigational new drug application from Ceruvia Lifesciences to conduct a phase 2 clinical trial to determine the safety and efficacy of synthetic psilocybin for the treatment of obsessive-compulsive disorder.

“With positive preliminary results from a Ceruvia-funded pilot phase 2 study taking place at Yale School of Medicine, we are excited to have received FDA approval to begin our phase 2 clinical trial to examine the efficacy and safety of psilocybin in treating OCD,” Ceruvia CEO Carey Turnbull said in a company press release. “With few effective treatment options available for the almost 4 million Americans who suffer from OCD, our phase 2 clinical trial is an important step in helping these patients dramatically improve the quality of their lives.”

The clinical trial will be a multicenter, randomized, double-blind, active placebo-controlled trial that will examine the safety and efficacy of synthetic psilocybin for the treatment of OCD symptoms.

The company said 105 participants will receive either 25 mg of SYNP-101 (synthetic psilocybin) or active placebo. The primary endpoint of the trial is to determine the reduction of OCD symptoms for up to 12 weeks after a single dose of SYNP-101.

The trial will begin in the second half of 2022, the company said in the release.