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Fda Fast Track

All articles tagged with #fda fast track

health-and-medicine1 month ago•7 min saved

One-Night Pill Cuts Sleep Apnea Breathing Interruptions by 44%

A once-nightly oral pill called AD109 (aroxybutynin plus atomoxetine) reduced the apnea–hypopnea index by about 44% in a six-month phase 3 trial across 646 adults who could not tolerate CPAP, with improvements in nighttime oxygen metrics and overall disease severity (over 40% moved to a less severe category and 18% achieved complete control). Side effects were generally mild (dry mouth, nausea, insomnia, difficulty urinating), with about 21% discontinuing. An NDA has been submitted and FDA Fast Track designation suggests a potential 1Q 2027 action date if accepted for review.

via Science Daily|

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

health4 months 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

health4 months 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