Benuvia Operations has been awarded a five-year contract by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), for the Good Manufacturing Practice (GMP) synthesis of psilocybin and other bulk drug substances.
The NIH contract will support the research and development of high-quality active pharmaceutical ingredients (APIs) for substance use disorders and mental health conditions. Benuvia will initially focus on the synthesis and scale-up of psilocybin, a Schedule I substance under the Controlled Substances Act that was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for major depressive disorder in 2019 and treatment-resistant depression in 2018. As part of the contract, Benuvia will manufacture and deliver GMP-grade psilocybin for NIDA's preclinical toxicity studies and clinical trials.
"This contract highlights our leadership in the development and manufacturing of controlled substances under GMP conditions," said Terry Novak, CEO of Benuvia. "We are honored to support NIH's efforts in advancing groundbreaking research into innovative therapies for substance use disorders and mental health conditions. Our state-of-the-art capabilities enable us to supply the highest-quality pharmaceutical compounds that meet the most rigorous regulatory standards."
Psilocybin is a naturally occurring psychedelic compound that comes from certain types of mushrooms. The drug is being evaluated in clinical studies as a potential treatment for many health disorders, including depression, anxiety, and substance use disorders. Historically, psilocybin's classification as a Schedule I controlled substance has limited its availability for research purposes. Through this NIH contract, Benuvia will produce psilocybin under stringent GMP conditions, ensuring researchers can access a consistent, pharmaceutical-grade product that meets both FDA and Drug Enforcement Administration (DEA) regulations.
Mr. Novak continued, "Our mission at Benuvia is to provide high-purity, federally approved substances for scientific research and pharmaceutical development. We look forward to working with the NIH to help evaluate psilocybin's therapeutic potential for the millions of patients suffering from these conditions."