Apnimed Moves Closer To Phase III With Sleep Apnea Drug

Apnimed is going to conduct one more Phase II study in sleep apnea, mainly to assess subjective endpoint questionnaires, and then hopes to launch a Phase III program by autumn of 2022.

Woman wearing CPAP machine for sleep apnea
Apnimed hopes to develop the first drug to replace CPAP therapy in sleep apnea

Previous efforts to provide a drug therapy for obstructive sleep apnea patients have fallen short of the finish line but Apnimedsays it is getting closer to taking its daily, oral combination pill into pivotal Phase III trials after a pair of successful Phase II data readouts for AD109.

On 13 October, the Cambridge, MA-based company reported that AD109 – which combines the novel, selective antimuscarinic agent aroxybutynin with the selective norepinephrine reuptake inhibitor atomoxetine – met multiple endpoints in the APC-003 study in moderate-to-severe sleep apnea and in the APC-004 trial in mild-to-moderate disease

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