Jazz Pharmaceuticals plc announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and […]
Sleep Pharmaceuticals
Promising Results for Narcolepsy Type 1 Treatment, but Safety Concerns Arise
Takeda announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine. These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1. The […]
Philips Recalled CPAP/BiPAP Updated Tests Results
Royal Philips today provides an update on the comprehensive test and research program of its subsidiary Philips Respironics to assess potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific sleep therapy and ventilator devices under the voluntary June 2021 recall notification/field safety notice.* The risk […]
Avadel Pharmaceuticals Receives FDA Approval of Bedtime Narcolepsy Treatment
Avadel Pharmaceuticals plc announced that the U.S. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. With final approval, LUMRYZ becomes […]
ApniMed Secures $80 Million for Apnea Pill Phase 3 Trials
Apnimed, Inc. announced today that it has secured $79.75 million in an oversubscribed financing round that extends its Series C financing to a total of $142.25 million. The financing was led by existing investor Alpha Wave Ventures and included existing investors Sectoral Asset Management, Columbia-Seligman Investments and Tao Capital Partners, […]
Apnimed OSA Pill Completes Positive Phase 2 Clinical Trials
Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies to treat obstructive sleep apnea (OSA) and related disorders, announced positive topline results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of one-month duration. The topline results were positive for the company’s lead candidate for […]
Certain Philips Respironics Masks Recalled Due to Safety Issue
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The […]
Certain Philips Respironics BiPAP Machines Recalled
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the […]
Apnimed Sleep Apnea Pill Granted FDA Fast Track Designation
Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral pharmacologic AD109 for the treatment of OSA. “Fast Track designation is a significant […]
Recall: Dräger SafeStar 55 Breathing System Filters
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: LT2103 Devices Recalled in the U.S.: 35,950 Dates distributed: […]













