Agile Therapeutics Inc (NASDAQ: AGRX)’ Twirla Contraceptive Rejected By The FDA Again
The U.S. Food and Drug Administration has refused to approve Agile Therapeutics Inc (NASDAQ: AGRX)’ Twirla, a low-dose contraceptive patch said to offer more convenience compared to birth control pills and which is also reputed to have a better safety profile compared to other patches. The FDA said it had concerns over the adhesion of the patch as well as issues with the outsourced manufacturing facility that Agile Therapeutics is using. Shares of Agile Therapeutics Inc fell by 3.73% in Wednesday’s trading session to close the day at $2.84 per share following the news.
According to Agile Therapeutics most of the issues that the U.S. Food and Drug Administration had raised in the course of the review had been addressed but it was apparent that the pharmaceutical firm’s responses did not factor into the regulator’s decision.
Path to approval
“Bottom line, this is clearly disappointing news and there are several important questions that will remain unanswered until [Agile’s] meeting with FDA. But while questions remain, there still appears to be a path forward to approval…” Randall Stanicky, an analyst at RBC Capital Markets, said.
In a conference call executives of Agile Therapeutics said that the focus of the U.S. Food and Drug Administration on the stickiness of the patch came as a surprise. According to the executives however, their adhesion results demonstrated no problems and the pharmaceutical firm has no concerns as a result. The executives concluded that the changes that Agile Therapeutics had made were submitted to the FDA too late in the day for the regulator to conduct a review. They also expressed confidence that Twirla will get an approval sometime in the future.
Fresh study
This is not the first time that the U.S. Food and Drug Administration is refusing to approve Twirla. In 2013 the U.S. Food and Drug Administration demanded a fresh clinical trial to be conducted and the results of that study were released at the beginning of this year. With the effectiveness of Twirla seen as being similar to other existing products, investors were optimistic that the FDA would approve the contraceptive. Twirla’s rate of effectiveness is 96%.
The adhesion issues of Twirla were however what led the U.S. Food and Drug Administration to conclude that the results of the fresh trial that Agile Therapeutics conducted could have been impacted. Per an executive of the pharmaceutical firm, one of the individuals who encountered adhesion issues was a pro swimmer who practices for an average of five hours on a daily basis.
https://www.pharmpro.com/news/2017/12/fda-again-rejects-nda-agile-therapeutics-contraceptive-patch
