The US Food and Drug Administration (FDA) has accepted Agile Therapeutics New Drug Application (NDA) filing for AG200-15, a once-weekly, low-dose contraceptive patch.
The application will be subject to a standard review, with a ten-month Prescription Drug User Fee Act (PDUFA) date and an anticipated response in Q1 2013.
“We are very pleased with the FDA's acceptance of our AG200-15 NDA filing,” said Al Altomari, president and chief executive officer of Agile. “This is an important milestone for our company and reflects the unwavering commitment of the entire Agile team to advance a new contraceptive option for women. We will work closely with the FDA to bring AG200-15 to market as soon as possible.”
AG200-15 is a combination hormonal contraceptive patch, which in clinical studies has been shown to deliver a low dose of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with that of low-dose oral contraceptives. The phase III trials for AG200-15 enrolled more than 2,000 women, and formed the basis for the Company’s application to the US FDA in 2012.
The AG200-15 patch is applied once weekly for three weeks, followed by a fourth, patch-free week. The patch may be applied to the abdomen, buttocks, or upper torso, is soft and flexible with a cloth-like, silky feel, and designed to provide excellent adhesion, comfort, and appearance.
Agile Therapeutics is a pharmaceutical development company specializing in Women’s Healthcare products, with an initial focus on providing women with more options and more convenient methods of hormonal contraception.