The Magazine for Sleep Professionals
Friday, August 28, 2026
The thought of histamines might conjure up images of itchy hives or the tickling sensation just before a sneeze, but scientists have come to realize there is much more to histamines than their connection to allergies. Recent research reveals that histamines play a vital role in wakefulness. Produced by brain […]
Harmony Biosciences Holdings, Inc. announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH). Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged. “We […]
Sleep Pharmaceutical Update Nov/Dec 2024 Eight abstracts presenting data from across the sleep portfolio of Jazz Pharmaceuticals plc were featured at the 37th annual Psych Congress, held Oct. 29–Nov. 2, 2024 in Boston. That data included topline results of the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, […]
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 […]
