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Agile's Phase III Data For Twirla Patch Fall Flat, Raise Doubts On Approval

 
• By Emily Hayes

Twirla low-dose birth control patch doesn't work as well in heavier women in Phase III SECURE study, but Agile believes that this is a class effect and an artifact of the stringent, real-world study design requested by FDA.

Agile Therapeutics Inc. is counting on data from the Phase III SECURE study to support a refiling of its Twirla low-dose combined birth control patch, but the results have raised serious questions about the product's approval prospects and spooked investors.

Agile unveiled top-line results from the SECURE study of 2,032 women on Jan. 3, describing "positive" results for the Pearl...

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