WEST CONSHOHOCKEN, Pa., Nov. 28 /PRNewswire/ -- Agile Therapeutics, a pharmaceutical development company focused on novel transdermal products, announced today the successful completion of a Phase 2 clinical trial of a new low estrogen contraceptive patch. The clinical trial results demonstrated effective ovulation suppression.
Most contraceptive products contain both a progestin and estrogen and are associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of hormones delivered into the blood stream, particularly with higher levels of estrogen. In recent years, treatment trends have moved towards lower hormone exposure. The Agile patch is designed to deliver levonorgestrel and ethinyl estradiol, the same hormone combination found in many oral contraceptives with well-established safety records. Estrogen levels with the Agile patch are comparable to low dose oral contraceptives containing 20 - 30 ug of estrogen.
"Our recently completed phase 2 study was designed to characterize the pharmacokinetics and efficacy of the Agile weekly contraceptive patch. In the 23 women who completed the study, ovulation suppression, a widely accepted marker for effective pregnancy prevention, was achieved in 96% of the subjects. The goal of transdermal delivery is to smooth out the exposure to hormones by eliminating the daily peaks experienced immediately after taking oral contraceptive products," reported Dr. Hal Broderson, Chief Medical Officer of Agile Therapeutics. "We are extremely pleased with these outcomes, as they indicate that our new low estrogen Agile patch would be effective in delivering low doses of both estrogen and progesterone to provide fertility control."
"Both physicians and patients are concerned with exposure to high levels of hormones, particularly estrogen, when using contraceptive products over extended periods of time. Transdermal contraception has demonstrated enhanced patient compliance and, therefore, reliability of contraception. What's needed now is a product that combines the proven benefits of transdermal contraception with a low monthly estrogen dose," said Dr. Sheldon Segal, Distinguished Scientist, Population Council, and member of the Agile Therapeutics Scientific Advisory Board.
"The Agile patch has the right profile to satisfy a significant need in contraception," said Thomas M. Rossi, Ph.D., Chief Executive Officer, Agile Therapeutics. "We are quite enthused about bringing a low estrogen dose option to women who prefer the convenience and reliability of transdermal contraception. Our clinical program is on track and we are moving into the next stage of development."
The transdermal patch for contraception has proven to be a popular choice among women. Ortho Evra(R), the only contraceptive patch on the U.S. market, is expected to exceed $500 million in sales in 2005. The FDA recently required a change to the Ortho Evra(R) package insert to reflect that the product delivers 60% more ethinyl estradiol than oral contraceptives containing 25-35ug of estrogen. Ortho Evra is marketed by Ortho-McNeil, a subsidiary of Johnson & Johnson (JNJ).
Agile Therapeutics (http://www.agiletherapeutics.com) is a pharmaceutical development company focused on novel transdermal products to help women manage their healthcare needs effectively with a convenient dosage form. The Company plans to initiate partnering discussion with leading Women's healthcare companies to further develop and commercialize the Agile low dose estrogen contraceptive patch.
Agile Therapeutics, Inc.CONTACT: Thomas Rossi, Ph.D., Chief Executive Officer of AgileTherapeutics, Inc., +1-610-940-0300
Web site: http://www.agiletherapeutics.com/
