The Magazine for Sleep Professionals
Tuesday, July 28, 2026
Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.1 Zepbound may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with […]
Avadel Pharmaceuticals plc , a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia (“Court”) ruled in favor of the Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure […]
Avadel Pharmaceuticals plc announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. “This approval represents an important milestone for the narcolepsy community, […]
Axsome Therapeutics, Inc. announced that it has reached an agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which was pending in the United States District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug […]
Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients six years of age and older with narcolepsy. The FDA separated the submission into two sNDAs […]
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist […]
Harmony Biosciences Holdings, Inc. has announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists […]
Axsome Therapeutics, Inc. has announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. AXS-12 also reduced excessive […]
Takeda has announced positive topline results from a randomized, double-blind, placebo-controlled, multiple-dose Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence with significant unmet need despite multiple approved therapies. It is […]
– SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care – Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023 Apnimed, Inc., […]
