Chewable Low-Dose Oral Contraceptive Represents New Birth Control Option
MORRISTOWN, N.J., Dec. 22, 2010 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals (NYSE: WPI) today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.
Watson's new oral contraceptive is a novel alternative to currently available birth control pills. This pill's unique dosing combination and proven 24-day, active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.
"The approval of this oral contraceptive further strengthens Watson's robust and expanding branded Women's Health portfolio," said Fred Wilkinson, Executive Vice President, Global Brands. "We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women."
The novel contraceptive product, licensed from a subsidiary of Warner Chilcott plc, will be actively marketed to physicians by Watson's Global Brands division beginning in the second quarter 2011.
Recent partnerships with Gedeon Richter, HRA Pharma, Itero Biopharmaceuticals, the Population Council and Columbia Laboratories have enabled Watson to expand its branded offerings and pipeline in women's health to include therapies for infertility, prevention of pre-term birth, uterine fibroids, emergency contraception and long-term contraception.
The approval of the oral contraceptive is based on data from a 12-month, Phase 3, multicenter, open-label study that evaluated the safety and efficacy of the product for pregnancy prevention. Among 1,251 women between the ages of 18 and 35 who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) in women was 2.01 pregnancies per 100 women-years of treatment. In addition, women in the clinical trial reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on Day 27 or 28.
The most common adverse reactions (>/= 2%) reported while taking the oral contraceptive in a clinical trial included nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%).
Nearly 11 million U.S. women use oral contraceptives to prevent pregnancy, and "the Pill" is the most common contraceptive method among women under 30 who practice contraception. The U.S. oral contraceptive market currently exceeds $4 billion annually and is dominated (86%) by combination (estrogen-progestin) pills.
Important Safety Information
Watson's new oral contraceptive is contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors or disease, and women who are pregnant.
The product does not protect against sexually transmitted infections (STI) or HIV.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. Women who are over 35 years old who smoke should not use the product.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health. Watson has operations in many of the world's established and growing international markets.
In the U.S., the Watson brand portfolio includes RAPAFLO®, GELNIQUE®, Oxytrol®, TRELSTAR®, Crinone® and INFeD®, and ella®. In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Abbott Laboratories, and Femring®, with Warner Chilcott plc. The Watson brand pipeline portfolio includes a number of products, including Prochieve®, under development with Columbia Laboratories for prevention of pre-term birth in women with a short cervix, recombinant follicle stimulating hormone (rFSH) in development with Itero Biopharmaceuticals for female infertility, Esmya(TM) under development with Gedeon Richter for the treatment of uterine fibroids, and two novel new contraceptives.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Watson Forward-Looking Statement
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson, its subsidiaries, and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid affecting, among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's annual report on Form 10-K for the year ended December 31,2009 and Watson's quarterly report on Form 10-Q for the period ended September 30, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Watson Pharmaceuticals