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| |  FDA Advisory Panel Recommends Prozac For Premenstrual Dysphoric Disorder INDIANAPOLIS, IN -- November 4, 1999 -- The U.S. Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee unanimously recommended approval of Eli Lilly and Company’s Prozac® (fluoxetine hydrochloride) for the treatment of premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS). If approved by the FDA, fluoxetine will be the first prescription medication indicated for the treatment of PMDD. PMDD affects 3 percent to 5 percent of menstruating women in the United States. Sufferers experience a range of chronic emotional and physical symptoms that appear the week or two before, and remit within days of, the onset of menses. Symptoms of PMDD are severe enough to interfere with social functioning and affect interpersonal relationships. Studies have shown that women treated with fluoxetine had a statistically significant reduction in mood and physical symptoms and functional impairment compared with women taking placebo. These improvements were demonstrated within the first menstrual cycle. "We are pleased with the committee’s decision and look forward to continuing an ongoing dialogue with the FDA to obtain approval to market fluoxetine to treat PMDD," said Rajinder Judge, M.D., director and global physician for fluoxetine with Lilly Research Laboratories. For a PMDD diagnosis, the patient must have: -- five or more of the following symptoms during most menstrual cycles in the past year: irritability, tension, depressed mood, mood swings, decreased interest in usual activities, difficulty concentrating, lethargy, marked change in appetite, insomnia or hypersomnia, sense of being overwhelmed, and physical symptoms such as breast tenderness and bloating. One or more of these symptoms must be depressed mood, tension, mood swings or irritability; -- a disturbance that significantly interferes with social or occupational functioning; -- symptoms that are not an exacerbation of another disorder, such as major depressive disorder.
The etiology of PMDD has not yet been established, but research suggests that it could be caused by an abnormal biochemical response to normal hormonal changes. Some studies have shown that the routine changes in estrogen and progesterone before menstruation causes, in some women, a serotonin deficiency that may induce PMDD. "Fluoxetine hydrochloride, a selective serotonin reuptake inhibitor that helps restore the balance of serotonin, has been shown in clinical studies to reduce the emotional as well as physical symptoms of PMDD and to reduce functional impairment," said Meir Steiner, M.D., Ph.D., St. Joseph’s Hospital, McMaster University, Ontario, Canada. Dr. Steiner is the lead researcher of the largest study of fluoxetine for PMDD. The data from this study were presented at today’s hearing. The disease course of PMDD is different from both major depression and PMS. Major depression is episodic and its symptoms can persist for weeks, months or years. Also, major depression is not linked to the menstrual cycle. PMDD differs from the broader classification of PMS in the severity and multiplicity of symptoms and the extent of functional impairment that results. "Women should never again be told they ‘just have to live with’ their symptoms," said Jean Endicott, Ph.D., director of the Premenstrual Evaluation Unit at Columbia Presbyterian Medical Center. "PMDD is treatable. Recognizing and treating this condition is a huge advancement for women’s health."
Clinical Studies The FDA advisory committee’s decision to recommend approval of fluoxetine hydrochloride for the treatment of PMDD was based in part on safety and efficacy results from the randomized, double-blind placebo-controlled trials presented. Patients were administered between 20 mg and 60 mg of fluoxetine hydrochloride or placebo daily for up to six months. The studies showed that women taking fluoxetine had statistically significantly greater improvements in mood and physical complaints and reductions in functional impairment compared with patients taking placebo. These improvements were recorded as early as the first cycle. The safety profile of fluoxetine in these studies was similar to that established by clinical trials in depression, OCD and bulimia. The rate of treatment discontinuation due to an adverse event was not significantly different between fluoxetine 20 mg/day and placebo. The most commonly observed adverse events associated with the use of fluoxetine hydrochloride vs. placebo in combined U.S.-controlled clinical trials for depression, OCD and bulimia were nausea (23 vs. 10 percent), headache (21 vs. 20 percent), insomnia (20 vs. 11 percent), anxiety (13 vs. 8 percent), nervousness (13 vs. 9 percent) and somnolence (13 vs. 6 percent). Fluoxetine hydrochloride is currently marketed as Prozac® for the treatment of depression, OCD and bulimia. Eli Lilly and Company has asked the U.S. Food and Drug Administration to consider granting approval to use an additional trademark for the treatment of PMDD. The FDA has made no final decision concerning this trademark application. An additional trademark is being sought because depression and PMDD are distinct disorders with different diagnostic and treatment approaches. "Lilly’s primary goal is to help provide relief to the millions of American women who suffer from this disorder. Our research with women and physicians confirms that a treatment option with its own identity could help women and their physicians differentiate PMDD from major depression, ultimately educating PMDD sufferers about appropriate diagnosis, treatment and follow-up," said Gary Tollefson, M.D., Ph.D., president, Lilly Neuroscience Product Group, Eli Lilly and Company. "Independent research has shown that Prozac is one of the best known trademarks in the pharmaceutical industry, and it is closely associated with major depression." Fluoxetine hydrochloride is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at least five weeks after discontinuation with fluoxetine hydrochloride. Fluoxetine hydrochloride should be discontinued immediately if a rash or other possibly allergic phenomena appear for which an alternative etiology cannot be identified.
Related Links: Prozac® (fluoxetine hydrochloride) and Eli Lilly and Company.
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