Agile Therapeutics is starting to get testy after suffering yet another snub from the FDA, announcing this morning that it simply doesn’t agree with the regulators’ assertion that its contraception patch is faulty.
The company is strapping on boxing gloves over the matter, as the FDA’s requests could sink the company financially — unless it finds new ways to cover the bills.
Agile’s once-weekly, low-dose contraceptive patch called Twirla is a combination hormonal patch that contains ethinyl estradiol and levonorgestrel.
Following the company’s second bid for approval last December, the FDA issued a complete response letter noting concerns with Agile’s adhesion test methods. In response, the company proposed that its patient compliance programs should appease any concerns.
Friday morning, Agile said its meeting with the regulator brought bad news. The FDA isn’t convinced that the compliance programs fix the problem, and still feels that Agile’s adhesive for the patch is no good. The FDA has suggested the adhesive be completely reformulated and re-tested. After fixing the adhesion problem, Agile would have to prove bioequivalence to the earlier version of the patch.
Agile isn’t taking the news lying down, issuing a statement Friday that it “disagrees with the FDA’s conclusions on the adhesion of Twirla and our patient compliance programs.” Al Altomari, the company’s chairman and CEO, had this to say:
We believe we have demonstrated an adhesion profile for Twirla that supports approval based on extensive data from our Phase II studies, including an extreme conditions trial, and our three Phase III trials. We also believe that we have planned compliance and education programs that can address the issues raised by the FDA and will support patient use of the product once it is approved. While we will continue to evaluate all of our options on next steps, we expect we will pursue formal dispute resolution. We will provide an update when we move forward.
This isn’t the first time Agile’s been rejected by the FDA. The company submitted the patch for FDA approval back in 2013 but struck out. At the time, regulators asked the company to do additional clinical trial work and provide the FDA with extra information on manufacturing.
The FDA’s recent decision puts Agile in a tough position financially. The company’s stock was decimated back in December with news of the second rejection, dropping nearly 50% overnight and barely recovering since. Now, Altomari says the company’s going to have to get creative to stay operational.
“In light of the feedback from the FDA, we also are re-evaluating our business plan to identify ways to extend our ability to fund the company’s operations,” Altomari said.
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