Societal CDMO Announces Expansion of Controlled Substance Manufacturing Capabilities to Address Expanding Psychedelic Drug Development Market

Company Secures Schedule 1 Controlled Substance Manufacturing License from Drug Enforcement Agency, Expands on 25 Years of Manufacturing of Schedule 2 Products

No Additional Investment Required to Support Clinical Trials for Psychedelic-Based Therapeutics

SAN DIEGO and GAINESVILLE, Ga., July 26, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; Nasdaq: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced the expansion of its broad suite of CDMO services to address the biopharmaceutical industry’s expanding activity in the area of psychedelic drug development. This targeted expansion of capabilities is enabled by the company’s several decades of experience in manufacturing and handling controlled substances, thus positioning Societal to address the growing psychedelic therapy sector and supporting the growing number of ongoing and planned clinical trials in this area.

Societal has completed key regulatory requirements for moving forward with this work and is now positioned to support customers with the manufacture of high-quality cGMP clinical supplies. This is highlighted by the company rapidly receiving U.S. Drug Enforcement Agency (DEA) approval to add certain Schedule 1 psychedelic compounds to their controlled substance manufacturing registration, expanding upon the Schedule 2 manufacturing registration it has held with the DEA for over 20 years. Importantly, Societal is able to expand its capabilities into the psychedelic drug development market without committing any additional capital investment.

“With a long track record of successfully manufacturing controlled substances for a number of biopharmaceutical companies, the Societal team has amassed deep expertise in seamlessly and effectively navigating this strictly regulated segment of the drug development space. In doing so, we have built strong credibility with the DEA, which we believe allowed for an efficient path to add Schedule 1 substances to our manufacturing registration,” said Richard Sidwell, Ph.D., senior vice president and chief scientific officer. “As more and more companies are focusing research and development efforts on the therapeutic potential of psychedelic compounds, we are aligned well to partner with those groups to support their clinical development programs. To this end, we are already engaging in discussions with various drug developers that are working in this area and are encouraged both by the substance of these conversations and the overall increase in interest within this therapeutic sector.”