FDA Approves New Indication for YAZ(R) to Treat Emotional and Physical Symptoms of Premenstrual Dysphoric Disorder (PMDD)
October 05 2006 - 7:30AM
PR Newswire (US)
- YAZ is the First and Only Birth Control Pill With Proven Efficacy
for PMDD - WAYNE, N.J., Oct. 5 /PRNewswire/ -- Berlex, Inc., a U.S.
affiliate of Schering AG, Germany (FSE: SCH; NYSE: SHR), announced
today that the U.S. Food and Drug Administration (FDA) has approved
YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) as the first
and only oral contraceptive shown clinically effective for the
treatment of the emotional and physical symptoms of premenstrual
dysphoric disorder (PMDD) in women who choose to use an oral
contraceptive as their method of contraception. YAZ, which received
FDA approval for the prevention of pregnancy in March, 2006, is the
fastest growing oral contraceptive brand in the U.S.* PMDD is a
condition in which women's emotional and physical premenstrual
symptoms are disruptive enough to significantly impact
relationships, social activities and work productivity. Symptoms of
PMDD include mood swings, irritability, headaches, feeling anxious,
bloating and food cravings. The symptoms regularly occur seven to
10 days before menstruation begins, and resolve within a few days
of the onset of menses. While the symptoms of PMDD and premenstrual
syndrome (PMS) are the same, women with PMDD experience five or
more symptoms which are more severe. PMDD affects as many as 4.5
million women in the United States, and nearly 90 percent of these
women remain undiagnosed and untreated. PMDD is also linked to
higher healthcare costs related to more frequent visits to
healthcare providers, decreased work productivity and absenteeism.
"For years, women overwhelmingly told us that they want more from
their birth control pill than just reliable contraception," says
Reinhard Franzen, President and CEO of Berlex. "Very high on their
list of desired added benefits was the relief from the impact of
menstrual symptoms. We knew that our innovative progestin,
drospirenone, held promise due to its unique properties. We are
very happy that we can now offer YAZ as an effective contraceptive,
as well as a treatment for mood swings, bloating, and other
symptoms of PMDD." YAZ is the first birth control pill shown to
treat the emotional and physical symptoms of PMDD. YAZ combines the
innovative progestin drospirenone with 20 mcg of ethinyl estradiol
in a 24-day active hormone pill regimen. Unlike other progestins,
drospirenone has a mild diuretic effect (antimineralocorticoid
property). Further, drospirenone has been shown to block the
effects of male hormones in a woman's body (antiandrogenic
property**). In addition, the 30-hour half life of drospirenone
combined with the 24-day active hormone pill regimen result in less
hormonal fluctuation during the menstrual cycle. "Unlike other oral
contraceptives, YAZ delivers the progestin, drospirenone, in
combination with estrogen in a unique 24-day dosing regimen, both
of which may account for its positive effect on PMDD," said Andrea
Rapkin, M.D., Professor, Department of Obstetrics and Gynecology,
David Geffen School of Medicine, UCLA. "For my PMDD patients who
need a treatment to reduce their symptoms, as well as a safe and
effective contraceptive to prevent pregnancy, YAZ is an important
option that can meet both of their healthcare needs in a single
pill." PMDD Clinical Study Results In a multicenter, double-blind,
randomized, parallel clinical trial of 450 women aged 18-40 with
symptoms of PMDD, YAZ was significantly superior to placebo in
improving interpersonal relationships, work productivity and
enjoyment of hobbies/social activities. Forty-eight percent of YAZ
patients experienced a reduction in symptom severity by at least
half, as measured by the Daily Record of Severity of Problems(1), a
validated tool used to diagnose PMDD by tracking premenstrual
symptoms and their severity on a daily basis. In a separate
multicenter, placebo-controlled, randomized, crossover,
confirmatory trial, patients experienced twice the improvement in
symptoms scores versus placebo. YAZ was well tolerated by the
majority of women in the clinical trials. Information About PMDD
According to standard diagnostic criteria, five or more
premenstrual symptoms must be present and severe enough to
significantly interfere with a woman's life. At least one of the
symptoms must be an emotional symptom such as mood swings, anger,
irritability or tension. Physical symptoms of PMDD include breast
tenderness, bloating and headache. Women with PMDD feel less
interest in daily activities, have difficulty concentrating and may
experience other symptoms such as food cravings. About YAZ As with
YASMIN(R) (3 mg drospirenone/30 mcg ethinyl estradiol), YAZ
contains the innovative progestin drospirenone. Drospirenone
exhibits antimineralocorticoid and antiandrogenic** properties
unlike any other progestin available in oral contraceptives. YAZ is
available in the U.S. by prescription only. The most common side
effects were similar to other oral contraceptives and include upper
respiratory infection, headache, breast pain, yeast infection
(vaginal moniliasis), vaginal discharge (leukorrhea), diarrhea and
nausea. Important Information about YAZ YAZ contains 3 mg of the
progestin drospirenone that has antimineralocorticoid activity,
including the potential for hyperkalemia in high-risk patients,
comparable to a 25-mg dose of spironolactone. YAZ should not be
used in patients with conditions that predispose to hyperkalemia
(i.e., renal insufficiency, hepatic dysfunction, or adrenal
insufficiency). Women receiving daily, long-term treatment for
chronic conditions or diseases with medications that may increase
serum potassium should have their serum potassium levels checked
during the first treatment cycle. Medications that may increase
serum potassium include ACE inhibitors, angiotensin-II receptor
antagonists, potassium-sparing diuretics, potassium supplementation
medications, aldosterone antagonists and NSAIDs. OCs do not protect
against HIV infection and other sexually transmitted diseases. The
use of OCs is associated with increased risks of several serious
side effects. Cigarette smoking increases the risk of serious
cardiovascular side effects; women who take OCs are strongly
advised not to smoke. YAZ has been shown to be effective for the
treatment of symptoms of PMDD but has not been evaluated for the
treatment of premenstrual syndrome (PMS). The effectiveness of YAZ
for the treatment of symptoms of PMDD has not been evaluated for
more than three menstrual cycles in clinical trials. Information
for Consumers Women who would like to learn more about YAZ should
call the toll-free number 1-888-BERLEX-4 or visit
http://www.yaz-us.com/. About Berlex Berlex, a U.S. affiliate of
Schering AG, Germany (FSE: SCH; NYSE: SHR), is committed to
addressing unmet medical needs through research and development in
the areas of oncology, gastroenterology, women's health diagnostics
and neurology. Berlex also markets diagnostic imaging agents,
innovative treatments in the areas of female healthcare and
oncology, as well as specialized therapeutics for life-threatening
and disabling diseases of the central nervous system and
cardiovascular system. Berlex has business operations in New
Jersey, California and Washington. For more information, please
visit http://www.berlex.com/. Certain statements in this press
release that are neither reported financial results nor other
historical information are forward-looking statements, including
but not limited to, statements that are predictions of or indicate
future events, trends, plans or objectives. Undue reliance should
not be placed on such statements because, by their nature, they are
subject to known and unknown risks and uncertainties and can be
affected by other factors that could cause actual results and
Berlex's plans and objectives to differ materially from those
expressed or implied in the forward-looking statements. Berlex,
Inc. undertakes no obligation to update publicly or revise any of
these forward-looking statements, whether to reflect new
information or future events or circumstances or otherwise. *
Source: Wolters Kluwer Health, Pharmaceutical Audit Suite, April
2006 - August 2006. Based on total monthly prescription counts from
product launch in April 2006 to August 2006, compared to other
branded oral contraceptives only. ** Antiandrogenic activity seen
in preclinical studies. (1) Yonkers, K. et al. "Efficacy of a New
Low-Dose Oral Contraceptive with Drospirenone in Premenstrual
Dysphoric Disorder." DATASOURCE: Berlex, Inc. CONTACT: Media: Rose
Talarico of Berlex, Inc., , +1-973-305-5302; or Elyse Margolis of
Ogilvy PR Worldwide, , +1-212-880-5329; or Investors: Joanne Marion
of Schering Berlin, Inc., , +1-973-487-2164 Web site:
http://www.berlex.com/ http://www.yaz-us.com/
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