A New Chapter For Orexin Therapies: What's Changing In Drug Development

The orexin field has entered a pivotal new phase, marked by two major regulatory milestones that could reshape the future of sleep and wakefulness therapies. In this insightful discussion, AltaSciences experts examine the FDA approval of the first orexin receptor 2 agonist for narcolepsy type 1 and the DEA’s proposal to reclassify dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V. Together, these developments reflect significant advances in the scientific understanding of orexin biology and evolving perspectives on abuse potential.

Beyond the headlines, the conversation explores how regulators assess abuse liability using a totality-of-evidence approach, including nonclinical studies, human abuse potential assessments, clinical safety data, epidemiology, and post-marketing experience. The discussion also highlights the challenges sponsors face when preclinical and clinical findings appear discordant, and why early planning is critical for successful regulatory outcomes.

As interest in orexin-targeted therapies expands across narcolepsy, insomnia, hypersomnia, and other CNS disorders, sponsors must develop integrated strategies that align clinical development, abuse liability evaluation, and regulatory planning from the outset. Explore the full discussion for practical insights into navigating this rapidly evolving therapeutic landscape.