Contract development and manufacturing organisation Benuvia Operations LLC announced on Tuesday that it has received a five-year contract from the National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH), for the Good Manufacturing Practice (GMP) synthesis of psilocybin and other bulk drug substances.

This 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 US 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.

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.