Apnimed, Inc. has announced positive topline results from its second pivotal Phase 3 clinical trial of Apnimed’s lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight […]
Tag: SLEEP PHARMACEUTICALS
Harmony Strengthens Patent With ANDA Settlement
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
FDA Approves Zepbound for Obstructive Sleep Apnea with Obesity
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 Announces Favorable Ruling On Lumryz
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 […]
Centessa Receives FDA Clearance for Phase 1 Clinical Trial of Promising Narcolepsy Treatment
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 […]
Apnea Pill: First Patient Dosed in Second Phase 3 Clinical Trial
– 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., […]
Jazz Pharmaceuticals Presents Latest Advancements at World Sleep 2023
Jazz Pharmaceuticals plc announced that the Company and its partners will present 14 abstracts from across its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, held October 20-25 in Rio de Janeiro, Brazil. The oral presentations include findings from the real-world TENOR study, […]
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 […]
Sleep Lab Magazine SLEEP 2023 Conference Edition
Sleep Lab Magazine SLEEP 2023 Conference Edition Cover Article Women and Sleep Kin Yuen, MD Feature Articles Sensor Integration: A Paradigm Shift for Oral Appliances Nathan Costiuc, MSN, APRN, FNP-BC Can’t Stop Dreaming: Taylor’s Narcolepsy Story Taylor Dillon Issue Extras SLEEP 2023 Select Exhibitors The Sleep Technologists Behind the V-Com […]
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 […]












