reboxetine/oxybutynin (AD128) / Apnimed - LARVOL DELTA

The norepinephrine reuptake inhibitor reboxetine alone reduces obstructive sleep apnea severity: a double blind, placebo controlled, randomized, cross-over trial. (PubMed, J Clin Sleep Med) - "These findings show the first evidence that reboxetine alone reduces OSA severity. The data provide novel insight into the role of norepinephrine reuptake inhibitors on upper airway stability during sleep and are important to inform future pharmacotherapy development for OSA."

Journal • CNS Disorders • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

OXYREB: Effect of AD128 to Treat Obstructive Sleep Apnea (clinicaltrials.gov) - P2/3; N=15; Completed; Sponsor: Raphael Heinzer; Recruiting ➔ Completed

Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

New Data Presented at American Thoracic Society Meeting Reinforces the Potential of an Oral Drug Combination Therapy for the Treatment of Obstructive Sleep Apnea (Businesswire) - P2, N=20; NCT04449133; "Apnimed...announced today that researchers from Istituto Auxologico Italiano and Brigham and Women’s Hospital presented data on the company’s investigational treatment for obstructive sleep apnea, AD128, at the American Thoracic Society (ATS) Meeting, taking place from May 14-19, 2021. The data presented confirm and expand upon prior research by Apnimed and its affiliates demonstrating the potential of pharmacotherapy to treat obstructive sleep apnea (OSA)...The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased next-day vigilance (assessed with a psychomotor vigilance test, PVT) after 1-week of therapy...These results confirm and expand upon previous findings that the combination of noradrenergic and antimuscarinic agents is likely to be effective in OSA. Further, the data highlight novel possibilities for pharmacotherapy to treat OSA."

P2 data • CNS Disorders • Obstructive Sleep Apnea • Sleep Disorder

Study of a Combination of ReboxetineOxybutynin Versus Placebo in Obstructive Sleep Apnea Studio di una combinazione di ReboxetinaOssibutinina (AD128) Versus Placebo nelle Apnee ostruttive del Sonno (clinicaltrialsregister.eu) - P2; N=20; Terminated; Sponsor: ISTITUTO AUXOLOGICO ITALIANO

Clinical • New P2 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Study of AD128 Versus Placebo in Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: Istituto Auxologico Italiano; Recruiting ➔ Completed; Trial completion date: Jul 2021 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

OXYREB: Effect of AD128 to Treat Obstructive Sleep Apnea (clinicaltrials.gov) - P2/3; N=15; Recruiting; Sponsor: Raphael Heinzer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Obstructive Sleep Apnea • Sleep Apnea • Sleep Disorder

Study of AD128 Versus Placebo in Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Istituto Auxologico Italiano; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Obstructive Sleep Apnea • Sleep Disorder

Study of AD128 Versus Placebo in Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Istituto Auxologico Italiano

Clinical • New P2 trial • Obstructive Sleep Apnea • Sleep Disorder