SOURCE: Agile Therapeutics

Agile Therapeutics

June 21, 2012 16:00 ET

Agile Therapeutics to Present at the 12th European Society of Contraception and Reproductive Health Congress

Agile's New Contraceptive Patch Found Effective in Both Normal Weight and Overweight or Obese Women; Recent Increase in Pearl Index Found to Be Unrelated to Obesity

PRINCETON, NJ--(Marketwire - Jun 21, 2012) - Agile Therapeutics, a pharmaceutical company focused on developing and commercializing more convenient women's contraceptive products, announced today that Dr. Andrew Kaunitz, OB-GYN at University of Florida-Jacksonville College of Medicine, will be giving a presentation entitled Increase in US Pearl Index (PI) Over Time Is Not Due to Obesity: Findings From a Recent Randomized Phase 3 Trial at the 12th European Society of Contraception and Reproductive Health Congress. The Congress takes place in Athens, Greece from June 20-23, 2012.

Dr. Kaunitz's presentation will focus on results from the recently completed Phase 3 trial for Agile's AG200-15, a once-weekly, low-dose contraceptive patch for which Agile recently filed an NDA. This trial, the first such trial with no weight restriction, enrolled women representative of the BMI distribution in the US population of women 18-40 years old, with a third of the patients obese, and 50% of them having a BMI ≥35 kg/m2.

The study found that AG200-15 was effective for both obese and normal weight women. There has been a continuous increase in the Pearl index since the 1990s in the United States, and this study demonstrated that obesity is not a factor in this increase, indicating that compliance could be the reason behind it. The increase in the Pearl index may be related to the decrease in compliance associated with the inclusion of low socioeconomic status women in trials, rather than increasing obesity.

"I look forward to sharing these results from this phase 3 study at the ESC Congress," said Dr. Kaunitz. "These results indicate that a lack of compliance, rather than obesity, could be the explanation for the continuous increase in the Pearl index in the United States since the 1990s, suggesting that compliance is an area that may merit additional research."

About AG200-15
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 the efficacy and safety profile 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 Food and Drug Administration 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.

About Agile Therapeutics
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. The company's lead product, AG200-15, is a once-weekly contraceptive patch that has been submitted to the FDA for approval. In addition, Agile is also developing a low dose, progestin-only contraceptive patch, AG890 (formerly AG900). Both AG200-15 and AG890 incorporate proprietary transdermal delivery technology, Skinfusion®, developed by Agile, consisting of an active and peripheral adhesive system that allows stable drug delivery and dependable adhesion over seven days. For more information, please visit http://www.agiletherapeutics.com.

About the European Society of Contraception and Reproductive Health
The European Society of Contraception and Reproductive Health (ESC) was founded on December 26, 1988 in Paris, France. The aims of the Society are as follows:

  • To improve and facilitate knowledge and use of contraception, abortion, sexually transmitted infections and reproductive health care in the countries of Europe.
  • To promote the harmonisation of different policies concerning contraception and reproductive health care in the countries of Europe.
  • To promote availability of all methods of contraception in the countries of Europe.
  • To carry out epidemiological and sociological studies and other types of research on contraception and reproductive health care in the countries of Europe.
  • To encourage relations between the European Society of Contraception and Reproductive Health and other appropriate organisations in Europe and throughout the world.
  • To share knowledge and experience of contraception with countries outside Europe.

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