The U.S. Food and Drug Administration has asked for additional work, including a new formulation and additional studies, before it could approve Agile Therapeutics Inc.'s contraceptive patch which is known as Twirla.
The regulator had identified certain deficiencies at the time it had rejected Agile Therapeutics' application for Twirla, prompting the company to schedule a meeting seeking further clarity from the FDA.
Aside from the manufacturing process and facility issues, Agile Therapeutics said the FDA raised concerns on Twirla's adhesion properties, pointing out the need to reformulate the patch's transdermal system and a formal adhesion study of the new formulation.
The FDA also required Agile Therapeutics an additional study to show bioequivalence, or the similarity of two drugs sharing the same desired effect, based on the data and information available for the drug's original formula.
If the company meets the FDA's requirements, the U.S. regulator will discuss Twirla's safety and effectiveness in an advisory committee meeting to assess the drug's benefits and risks.
However, Agile Therapeutics CEO and Chairman Al Altomari said it disagrees with the FDA's conclusions and announced intentions to file a formal dispute resolution. According to the CEO, the company was able to demonstrate the patch's adhesion profile in its phase 2 and phase 3 studies.
The company will also review its business strategy to determine possible funding options for its operations, Altomari added.
