Agile Therapeutics Inc said the U.S. Food and Drug Administration declined to approve its contraceptive patch for the second time, sending the drug developer’s shares down about 50 percent.
The health regulator cited deficiencies related to its quality adhesion test methods and asked the company to resolve the observations found during an inspection of its third-party manufacturing facility, Corium International Inc.
Agile’s lead product, Twirla, is a once-weekly, low-dose contraceptive patch made from a combination of ethinyl estradiol and levonorgestrel.
In 2013, the FDA rejected Twirla, citing efficacy issues and sought additional clinical data. After that, Agile completed a late-stage trial in 2,032 women and once again applied for approval in June.
Expressing surprise over the decision, Agile said the drug regulator has not identified any safety issue related to the product and it intends to seek a meeting with the regulator soon.
The company also pointed out that an amendment addressing the regulator’s concerns about the manufacturing facility and issues related to quality adhesion test methods was not reviewed before the FDA decided to reject the drug.
The amendment was submitted on Dec 1, Chief Executive Al Altomari said on a conference call, adding that he is surprised the FDA didn’t review it.
If approved, Agile’s Twirla would have competed with Mylan NV’s Xulane, a generic version of a Johnson & Johnson’s Ortho Evra product that was withdrawn in 2015.
Xulane generated sales of $211 million last year, a fraction of the $5.5 billion U.S. contraceptive market.
(Reporting by Divya Grover in Bengaluru and Toni Clarke in Washington; Editing by Anil D’Silva and Arun Koyyur)