Host: Sara W. Koblitz

Guest: Michael J. Thorpy, MD

Since the release of this activity, the FDA has approved the use of Once-Nightly Sodium Oxybate. Visit the FDA statement dated May 1, 2023.
https://firstwordpharma.com/story/5734060

While most clinicians are aware of a drug being either “approved” or “not approved” by the FDA, many are not familiar with the term “tentative approval.” Leading experts, attorney Sara Koblitz, JD, and Dr. Michael Thorpy, review the FDA approval process, explore how “tentative approval” is currently impacting treatment in the field of sleep medicine, and discuss how “non-drug” issues are related to delayed FDA approval. Review the latest safety and efficacy pivotal trial data associated with once-nightly sodium oxybate and find out if we’re truly on the cusp of a new awakening in sleep medicine.