JERUSALEM—Teva Pharmaceutical Industries Ltd. has announced thatits Quartette(levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for theprevention of pregnancy has received approval from the U.S. Food and Drug Administration (FDA). Quartette represents the next generation ofextended-regimen oral contraceptives to be approved by the FDA, Teva reports, and wasdesigned to minimize breakthrough bleeding (BTB) between scheduledperiods.
"Breakthrough bleeding can be experienced with any birth control pill,especially during the first few months, and is one of the reasons alarge number of women discontinue extended regimens," said Dr. James A.Simon, clinical professor of obstetrics and gynecology at the GeorgeWashington University School of Medicine, as quoted in Teva's news release about the approval. "The estrogen in Quartetteincreases at specific points and provides four short light periods ayear. Breakthrough bleeding decreases over time, which might helpencourage patient adherence."
The Phase III clinicaltrial for Quartette, which involved more than 3,000 women, found that the product was97-percent effective at preventing pregnancy. Data further demonstratedthat the most common adverse reactions (=2%) in the Phase III clinicaltrial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting,acne, dysmenorrhea, weight increased, mood changes, anxiety/panicattack, breast pain and migraines. The primary clinical trial thatevaluated the efficacy of Quartette also assessed BTB and found that BTB andunscheduled spotting decreased over successive 91 day cycles.
Quartette involves a 91-day oral regimen, whereby the dose ofestrogen increases at three distinct points over the first 84 days andthe amount of progestin remains consistent; this is followed by sevendays of 10 mcg of ethinyl estradiol.
"Teva is the leader in the pharmaceutical industry in the marketing anddevelopment of extended regimen oral contraceptives, and Quartetterepresents the next generation of these contraceptives. It is a uniquelydifferentiated product and is based on Teva's research into whenbreakthrough bleeding is most likely to occur with these regimens," saidJill DeSimone, senior vice president & general manager, Global TevaWomen's Health. "Quartette is the newest product in our global women'shealth franchise and is an example of our dedication to providing avariety of contraceptive and family planning options that fit women'slifestyles."