FDA “Tentative Approval” of Once-Nightly Sodium Oxybate: Not a “Product” Issue, but a “Patent” Issue on the Cusp

FDA “Tentative Approval” of Once-Nightly Sodium Oxybate: Not a “Product” Issue, but a “Patent” Issue on the Cusp

FDA “Tentative Approval” of Once-Nightly Sodium Oxybate: Not a “Product” Issue, but a “Patent” Issue on the Cusp

It’s ALMOST the dawn of a new day for clinicians who manage narcolepsy and their patients. Wake up to FDA “tentative approval” and the latest data. 

Available credits: 0.25

Time to complete: 15 minutes


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  • Overview

    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.

    Why is the FDA so tentative about a new option for patients with narcolepsy? Tune in to get a better understanding of the FDA approval process and how the “tentative approval” status of once-nightly sodium oxybate is currently impacting narcolepsy management. Explore how “non-drug” issues are related to delayed FDA approval and how the latest data could change your clinical practice and significantly improve the lives of your patients with narcolepsy in the near future.

  • Disclosure of Conflicts of Interest

    In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.

    Sara W. Koblitz, JD
    Hyman, Phelps & McNamara, P.C.
    Washington, DC 

    Consulting Fees: Avadel Pharmaceuticals

    Michael J. Thorpy, MD
    Director, Sleep‐Wake Disorders Center
    Montefiore Medical Center
    Professor of Neurology
    Albert Einstein College of Medicine
    Bronx, NY 

    Consulting Fees: Axsome, Balance Therapeutics, Eisai Pharmaceuticals, Flamel/Avadel, Harmony Biosciences, LLC, Jazz Pharmaceutics, NLS Pharmaceuticals, Suven Life Sciences Ltd., Takeda Pharmaceutical Co., Ltd., XWPharma

    Reviewers/Content Planners/Authors:

    • Cindy Davidson has nothing to disclose.
    • Amanda Hilferty has nothing to disclose.
    • Brian P. McDonough, MD, FAAFP, has nothing to disclose.
    • Estelle Perera has nothing to disclose.
    • Jay Runyon has nothing to disclose.
    • Robert Schneider, MSW, has nothing to disclose.
  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • Define the FDA drug approval regulations surrounding “tentative approval” status
    • Describe the clinical outcomes from the pivotal trials of once-nightly sodium oxybate demonstrating its safety and efficacy
    • Identify the “non-drug” issues that are the basis of the delay in the FDA approval of once-nightly sodium oxybate
  • Target Audience

    This activity is designed to meet the educational needs of sleep medicine specialists, psychiatrists, neurologists, ENTs, and PCPs.

  • Accreditation and Credit Designation Statements

    In support of improving patient care, Global Learning Collaborative (GLC) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

    Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 0.25 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Global Learning Collaborative (GLC) designates this activity for 0.25 nursing contact hours. Nurses should claim only the credit commensurate with the extent of their participation in the activity.

  • Provider(s)/Educational Partner(s)

    Prova Education designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties.

    Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the very best education in the most impactful manner and to verify its results with progressive outcomes research.

  • Commercial Support

    This activity is supported by an independent educational grant from Avadel Pharmaceuticals.

  • Disclaimer

    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Prova Education. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of Prova Education you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.

    Reproduction Prohibited
    Reproduction of this material is not permitted without written permission from the copyright owner.

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