High-Risk Pain Medications in Development More Likely to Receive Regulatory Approval

New pain treatment medications with high potential for abuse are significantly more likely than new medications with low abuse potential to make it through the development process and go to market, according to a recent retrospective study by researchers at Johns Hopkins University School of Medicine and the MIT School of Management.

Findings were published by the journal Anesthesiology.

Researchers analyzed 496 pharmaceutical development programs involving 399 unique active pharmaceutical ingredients between 2000 and 2020. Publicly available clinical trial metadata from databases provided by Informa Pharma Intelligence were used to determine the probabilities of success, duration, and survivorship of the pain medication development programs.

Of the drugs considered to have high abuse potential, 27.8% made it through development, compared to just 4.7% of developmental drugs with low abuse potential. The researchers noted that although the number of drugs with high abuse potential has decreased since 2010, such high-risk medications are still more likely to receive regulatory approval.

In an accompanying editorial, Michael S. Sinha, MD, JD, MPH, and Kelly K. Dineen Gillespie, RN, JD, PhD, concurred with Johns Hopkins assistant professor Dermot P. Maher, MD, MS, MHS, who worked on the study, advocating for more development of pain medications with better safety profiles.

“The National Institutes of Health (NIH) and other research sponsors must allocate funding toward the development of safer analgesics and nonpharmacologic pain management strategies,” Dr Sinha and Dr Gillespie wrote. “Expanding support for the NIH Helping to End Addiction Long-term (HEAL) Initiative is one way to achieve this goal.”

Dr Sinha and Dr Gillespie added that changes to public and private financing models that encourage interdisciplinary, multimodal, and time-intensive pain treatment programs are warranted.

“Investment in cross training for providers in pain medicine and substance use disorder treatment is needed, as well as trauma informed care,” they wrote. “Innovative, noninvasive biotechnology also holds promise.”

Reference

New drugs with high abuse potential more likely to be approved, go to market to treat pain. News release. American Society of Anesthesiologists. June 21, 2022. Accessed July 6, 2022.