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Ad109

All articles tagged with #ad109

health1 month ago•7 min saved

Nightly Pill Could Redefine Sleep Apnea Treatment

A six-month phase 3 study of AD109 (an oral combo of aroxybutynin and atomoxetine) in 646 adults with mild–severe obstructive sleep apnea showed a ~44% drop in the apnea-hypopnea index versus an 18% reduction with placebo, with improved oxygen metrics and about 40% moving to a lower OSA severity category and 18% achieving complete control; AD109 targets neuromuscular pathways to keep throat muscles active, offering an alternative for CPAP-intolerant patients. Safety was mostly mild; 21% discontinued due to side effects. The drug has FDA Fast Track status and an NDA is with the FDA, with potential action in early 2027.

via SciTechDaily|

#ad109 #cpap #fda-fast-track

health1 month ago•5 min saved

Oral Sleep Apnea Pill AD109 Nears FDA Sign-Off After Phase 3 Win

A phase 3 trial of the oral drug AD109 (a combo of aroxybutynin and atomoxetine) reduced the apnea-hypopnea index by about 44% versus 18% with placebo over 26 weeks in 646 patients with mild–severe obstructive sleep apnea, with roughly 42% moving to a lower severity category and about 18% no longer meeting OSA criteria. Side effects were mild (dry mouth, nausea, insomnia). The FDA has fast-tracked AD109, with a decision anticipated in 2027, potentially offering a convenient alternative to CPAP for patients unable or unwilling to use the machine.

via ScienceAlert|

#ad109 #cpap-alternative #fda-fast-track

health11 months ago•5 min saved

Apnimed's Oral Pill Shows Promise in Sleep Apnea Treatment

A new oral medication called AD109 shows promise in treating sleep apnea, potentially offering a more comfortable alternative to CPAP machines, with positive Phase 3 trial results indicating it could be approved by the FDA in 2026, though full data on side effects and efficacy in chronic conditions are pending.

via The New York Times|

#ad109 #clinical-trials #cpap-alternative

health2 years ago•1 min saved

"New Drug Offers Hope for Sleep Apnea Patients Beyond CPAP"

Researchers are conducting a third clinical trial for AD109, a drug that could potentially replace CPAP machines for people with mild obstructive sleep apnea. Developed by Apnimed, AD109 combines aroxybutynin and atomoxetine, and has shown promising results in improving sleep apnea symptoms. With 39 million Americans affected by sleep apnea, this drug could offer a more convenient treatment option.

via NewsNation Now|

#ad109 #apnimed #clinical-trials