Agile Therapeutics Inc (fka AGRX)

[bUrRpPPP!]

This will be the first twirla advisory committee. the previously cited crl issues had nothing to do with safety and/or efficacy of the twirla patch- the cited issues were adhesion and the mfg partner's (corium) ability to laser etch the labeling on the patch itself- and whether laser etching could be done without reformulation of the patch ingredients. adhesion issue was resolved thru a comparitive wear study which proved that twirla adhesion is now "non-inferior" to that of xulane (ortho-evra generic)- the only patch currently available on the chc market. Agile funded the integration of the laser etching capability mfg facility and twirla patch required no reformulation as a result of this process. Though slightly higher than that of xulane, because the study was not bmi (body mass) restrictive, twirla PI is within the fda acceptable range- and the lower estrogen dosage has proven to reduce the risk of blood clotting and other severe side effects of xulane.