Purdue Pharma LP has completed a Phase 1b dose-ranging study of a novel, potential first-in-class small molecule being investigated for its utility in insomnia associated with alcohol cessation. Following a recent meeting with the US Food and Drug Administration, Purdue is planning to initiate a Phase 2 proof-of-concept (POC) study for this molecule.

“Going forward, with a primary emphasis on internal and partnered research & development programs, we are pursuing new medications to address a variety of unmet needs for patients suffering from some of the most difficult to treat and debilitating conditions, including cancer and select central nervous system disorders,” says Craig Landau, MD, president and CEO, Purdue Pharma, in a release. “We are proud of the momentum we have generated in our oncology and central nervous system pipelines and are excited to work toward advancing research that has the potential to improve the lives of patients.”

The Phase 1b randomized, double-blind, cross-over study in subjects with insomnia disorder achieved its primary objective for improved sleep efficiency and secondary objectives for decreased wake time after sleep onset and increased total sleep time as measured by polysomnography, showcasing that the molecule had statistically significant improvement compared to placebo across a range of dose levels (1 mg, 3 mg, and 6 mg). The molecule also demonstrated favorable results on measures assessing next-day residual effects.

Subjects with insomnia disorder who were administered this molecule did not experience serious adverse events or discontinuations due to adverse events. Treatment emergent adverse events experienced by two or more subjects in any treatment arm were somnolence, dizziness, headache, and irritability.

“Our initial studies show a clear and exciting dose-effect relationship on sleep promotion in healthy subjects and now in patients with insomnia,” says John Renger, PhD, vice president, Head of Research & Development and Regulatory Affairs, Purdue Pharma. “We are in the midst of completing additional studies to understand this compound’s performance in both alcohol interaction and abuse liability clinical studies.”

Insomnia is a major challenge facing some patients recovering from alcohol use disorder in their struggle to maintain sustained abstinence from alcohol use. Previous studies of patients with alcohol use disorder have found untreated insomnia may interfere with recovery from the alcohol addiction and contribute to relapse during recovery.

This article discusses an investigational new drug under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational drug will successfully complete clinical development or receive regulatory approval.