FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA  approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD). 

The company is focused on the development and commercialization of neurotransformational medicines for patients suffering from hard-to-treat headaches, OCD and substance abuse disorders. Based on a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help them return to living their lives to the fullest. 

The next Phase 2 clinical trial, set to begin in the second half of 2022, will be led by Dr. Benjamin Kelmedi and Dr. Christopher Pittenger of Yale's School of Medicine. The study would follow an undergoing pilot Phase 2 study taking place at the same institution, which has shown positive preliminary results. 

"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," said Ceruvia's founder & CEO Carey Turnbull.

The multicenter, randomized, double-blind, active placebo-controlled clinical trial plans to enroll a total of 105 participants, who will receive 25mg of SYNP-101 or the active placebo, niacin. 

As stated by Ceruvia, the trial’s primary goal is to determine the reduction in obsessive-compulsive disorder symptoms for up to 12 weeks, after a single administration of SYNP-101. The treatment’s efficacy will be measured using the Yale-Brown Obsessive-Compulsive Scale, the most used and validated tool for assessing the clinical severity of OCD symptoms. 

Photo Courtesy of Annie Spratt on Unsplash.

Posted In: Carey TurnbullCeruvia LifesciencesFDA ApprovalCannabisNewsPsychedelicsFDASuccess StoriesStartupsSmall BusinessMarkets

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.