In Search of Future Blockbusters, Big Pharma Turns to Psychedelics

David Holman, Ph.D., director in Sterne Kessler’s Biotechnology & Chemical and Trial & Appellate Practice Groups, spoke with MLex on the future of psychedelics in the pharmaceutical industry.

“Psychedelics have been around for thousands of years, but now as a pharmaceutical product, it’s kind of a different area.” Holman noted that while psychedelics remain federally regulated as Schedule I drugs, “the perception of psychedelics has begun to shift away from being known only as a recreational hallucinogenic drug to a therapeutic pharmaceutical agent for treating mental disorders like depression and PTSD.”

He also suggested that “breakthrough therapy,” “the big pharma deals,” and other developments have helped legitimized the industry.

Holman explained how protections for psychedelic inventions rely on the same legal principles as other pharmaceutical inventions, “The process for psychedelics is not wildly different than anything we do with our other pharmaceutical clients who are in clinical trials and developing a clinical drug,” he continued. “I don’t think it requires an entirely new patent strategy per se. It’s just that there’s a new area of commercial growth.”

Due to most of the compounds being classified as controlled substances, the research can be difficult, “It’s a long process,” Holman said. “It’s not as easy to do clinical research, or even early-stage preclinical research, due to regulatory restrictions.”

Although there are challenges, acquisitions by large pharmaceutical companies suggest a future for psychedelic medicine. “Big Pharma is investing or betting on psychedelics,” Holman said. “These are billion-dollar deals.”