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Zoloft (Sertraline HCl) Receives FDA Approval For Treatment Of Premenstrual Dysphoric Mood Disorder

New Flexible Treatment Option for PMDD

NEW YORK, NY -- May 21, 2002 -- Pfizer Inc announced that it has received U.S. Food and Drug Administration (FDA) approval for Zoloft® (sertraline HCl) for the treatment of premenstrual dysphoric disorder (PMDD).

Studies supporting the new indication show that Zoloft is significantly more effective than placebo in treating women who suffer from this condition. PMDD is characterized by intense emotional and physical symptoms that occur during the time between ovulation and menstruation. Zoloft is the first and only approved PMDD treatment that is effective if taken either every day or for the two weeks before a woman's period.

"The approval of Zoloft for PMDD means that there is an important new, flexible treatment for women. Effectively treating PMDD can help women regain their ability to function on the days that had previously been lost to PMDD symptoms," said Cathryn Clary, MD, Worldwide Medical Team Leader, Depression and Anxiety, Pfizer Inc.

In two randomized, double-blind, placebo-controlled clinical trials involving a total of 532 women diagnosed with PMDD, Zoloft was significantly more effective than placebo in improving PMDD symptoms, including emotional symptoms (e.g., feelings of being depressed, hopeless, overwhelmed) and behavioral symptoms (e.g., angry or irritable, conflicts with people).

Improvement was noted whether Zoloft was dosed intermittently during the premenstrual phase of the menstrual cycle only, or when dosed continuously throughout the cycle. Women who took Zoloft continuously throughout their cycle also experienced significant improvements in physical symptoms (e.g., breast tenderness, bloating, headache).

PMDD is distinguished from premenstrual syndrome (PMS) by the severity of symptoms and the degree of their impact on a woman's daily activities and relationships. Additionally, the diagnostic criteria for PMDD require the presence of a distinct mood change during the symptomatic period, whereas PMS may not involve a mood change. In PMDD, symptoms are experienced to a degree that severely affects a woman's ability to function at home, at work and in her personal life.

While the symptoms of PMDD are of comparable severity to symptoms of major depressive disorder and other mood disorders, PMDD is distinguished from these disorders by its cyclical nature, with symptoms occurring between ovulation and menstruation. As many as three to five percent of women in the United States experience premenstrual symptoms that are severe enough to meet the diagnostic criteria for PMDD.

Zoloft is also indicated for depression, posttraumatic stress disorder (PTSD), and panic disorder (with or without agoraphobia), obsessive-compulsive disorder (OCD). It has been shown to be safe for long-term use in the treatment of pediatric OCD when used as prescribed. Zoloft is the first and only FDA-approved therapy for the long-term treatment of PTSD. Zoloft is the most prescribed brand of its kind in the United States and is available in 96 countries around the world. Since its approval more than a decade ago, millions of people have been treated with Zoloft.

Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) medicine. Patients must wait at least two weeks before switching from Zoloft to an MAOI or from an MAOI to Zoloft.

Zoloft is contraindicated in patients with a hypersensitivity to sertraline HCl or any of the inactive ingredients in Zoloft.

Some people taking Zoloft may have side effects. The most common side effects of Zoloft include upset stomach, having trouble sleeping, diarrhea, abdominal pain, dry mouth, sexual side effects, feeling unusually sleepy or tired, tremor, indigestion, increase of sweating, feeling agitated, and decreased appetite. In clinical studies with Zoloft, few patients were bothered enough by side effects to stop taking their medicine.

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best known consumer products.

SOURCE: Pfizer Inc

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