Regulatory, Setbacks

Denied: FDA rejects Agile’s contraception patch for second time

Agile Therapeutics $AGRX is suffering yet another rejection from the FDA this morning as regulators declined to approve its contraception patch for the second time. The company’s stock tanked on the news, falling 60% in pre-market trading Friday.

The FDA said the New Jersey company needed to reconsider its adhesion test methods and resolve some issues found during an inspection of a third-party manufacturing facility Corium International. Regulators also wanted Agile to address the implications of patch compliance during clinical trials and dropout rates.

Al Altomari

The company’s once-weekly, low-dose contraceptive patch called Twirla is a combination hormonal patch that contains ethinyl estradiol and levonorgestrel. Agile 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.

“We are clearly disappointed, and we are evaluating the FDA’s response,” said Agile’s chairman and CEO Al Altomari in a statement. “We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the complete response letter (CRL) and discuss a path to approval for Twirla. We will work closely with the FDA to address the points raised in the CRL as quickly as possible.”

 


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