FDA Approves New Drug Application for Teva’s Quartette™
Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette™ represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough bleeding (BTB) between scheduled periods. The approval of Quartette™ demonstrates Teva’s continued commitment to the development and production of an innovative range of pharmaceutical products that support the health of women around the world.
“Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens,” said Dr. James A. Simon, clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine. “The estrogen in Quartette™ increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence.”
The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette™. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette™ was 97 percent effective at preventing pregnancy. Data further demonstrated that the most common adverse reactions (≥2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette™ also assessed BTB. BTB and unscheduled spotting decreased over successive 91 day cycles. 1
Quartette™ features a unique 91-day oral regimen, whereby the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by seven days of 10 mcg of ethinyl estradiol.
“Teva is the leader in the pharmaceutical industry in the marketing and development of extended regimen oral contraceptives, and Quartette™ represents the next generation of these contraceptives. It is a uniquely differentiated product and is based on Teva’s research into when breakthrough bleeding is most likely to occur with these regimens,” said Jill DeSimone, senior vice president & general manager, Global Teva Women's Health. “Quartette™ is the newest product in our global women’s health franchise and is an example of our dedication to providing a variety of contraceptive and family planning options that fit women’s lifestyles.”