FDA Updates Warnings for Class of Drugs Used to Treat Narcolepsy

To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, a class of drugs used to treat narcolepsy, the US Food and Drug Administration (FDA) is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines.  The current…

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AASM Unveils 2023 Award Recipients

Five individuals have been selected as the 2023 American Academy of Sleep Medicine (AASM) award recipients for their contributions to the field of sleep medicine. They will be recognized Monday, June 5, during the plenary session of the SLEEP 2023 annual meeting of the Associated Professional Sleep Societies in Indianapolis.   “I congratulate this year’s award…

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Apnimed to Present Data on Investigational Oral Treatment for Sleep Apnea

Data from Apnimed’s MARIPOSA phase 2b trial—an efficacy, safety, and dose-finding study of one-month duration of its drug candidate for obstructive sleep apnea (OSA)—will be featured in an oral presentation and a poster presentation at The American Thoracic Society’s ATS 2023 International Conference in Washington, DC. “ATS 2023 will be our first opportunity to present…

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Zevra’s Leading Drug Candidate for Idiopathic Hypersomnia Treatment Advancing

 Zevra Therapeutics Inc, formerly KemPharm, announced KP1077, its leading clinical candidate for treating idiopathic hypersomnia, is advancing with plans to expand into narcolepsy.  Zevra reported continued advancement of a phase 2 clinical trial evaluating KP1077 as a treatment for idiopathic hypersomnia. Interim efficacy and safety data are expected as early as the third quarter, with…

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Longitudinal Monitoring Could Unleash the Full Potential of Home Sleep Testing

By Chaunie Brusie, RN, BSN In March, the US Food and Drug Administration (FDA) cleared the next generation of Wesper’s patch-based home sleep testing system for assisting in the identification of sleep apnea in adult patients. Unlike the company’s first-generation device, the new design has longitudinal sleep monitoring at the forefront. The flexible abdominal and…

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Philips Completes Risk Assessments for Recalled CPAPs and BiPAPs

Philips announced that risk assessments have been completed for CPAP and BiPAP sleep therapy devices under the June 2021 recall, and the company has provided a summary to the US Food and Drug Administration and other authorities for review.  This set of devices includes the first-generation DreamStation, System One, and DreamStation Go devices, representing approximately…

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