Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Summary

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Timeline

Start

2021-11-29

Primary completion

2022-07-20

Completion

2022-08-03

Outcome

Met primary endpoint

paper (-47.1%), from 19.4 (13.7-26.4) to 9.5 (6.1-19.3) in the AD109 5/75 mg arm (-42.9%; both P < 0.0001 vs. placebo) PMID 37812772 ↗

release “MARIPOSA showed that AD109 (aroxybutynin + atomoxetine) at both doses tested achieved a statistically significant reduction of AHI4 compared to placebo (p<0.001 vs. placebo).” apnimed.com ↗

release “The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).” apnimed.com ↗

Publications

• Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AD109	Unknown	2.5 mg	Oral
Subject	AD109	Unknown	5 mg	Oral
Subject	AD504	Unknown	—	Oral
Comparator	Atomoxetine	Other / unclassified	75 mg	Oral

Indications