×

UPDATE 1-Agile Therapeutics exploring funding options after FDA meeting

(Adds details, background)

May 18 (Reuters) - Agile Therapeutics Inc said on Friday it is looking for ways to fund operations after U.S. health regulators suggested that a new clinical trial may be required to test the company's stick-on contraceptive patch.

The U.S. Food and Drug Administration's (FDA) remarks on the patch, Twirla, come after it declined to approve the drug in December for the second time.

Agile said the FDA still had "significant concerns" about the adhesion properties of Twirla, which cannot be addressed through measures that the Princeton, New Jersey-based drug developer has already proposed.

In an April 16 meeting with the company, the FDA said Agile needed to reformulate certain properties of the patch and conduct a formal adhesion study with the new version.

"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," Agile Chief Executive Officer Al Altomari said in a statement.

Agile had $28.3 million in cash as of March 31 and said last week it expected the amount to be enough to meet operating requirements through the end of the year. (Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur)