NEW YORK, December 10 – Forest Laboratories, Inc. (NYSE: FRX) announced today the results of a clinical study, which showed that LexaproTM (escitalopram oxalate) is as effective and well tolerated as Zoloft® (sertraline hydrochloride). The purpose of the study was to evaluate whether the starting dose of Lexapro, 10 mg per day, could provide comparable efficacy to the full dosing range of Zoloft, 50 – 200 mg per day.
Study results showed that patients receiving a dose of 10 mg per day of Lexapro experienced similar efficacy compared to patients receiving a median dose of Zoloft of 150 mg per day. At week four, 46 percent of Zoloft-treated patients received 150 mg per day or higher, and at week eight, 65 percent received 150 mg per day or higher. To achieve a dose of 150 mg per day or higher, patients treated with Zoloft required at least two dose titrations. Both Lexapro and Zoloft belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). The study was presented in Puerto Rico at an annual meeting of neuropsychopharmacologists.
“In this study, most patients experienced relief from depressive symptoms. Patients treated with Lexapro received 10 mg throughout the study period, while patients treated with Zoloft received dosages based on depressive symptoms and the development of side effects,” said George Alexopoulos, M.D., Professor of Psychiatry at Weill Medical College of Cornell University. “Lexapro is an effective treatment for depression with simple dosing that may improve patient adherence.”
Each year, nearly 19 million adult Americans suffer from mild, moderate, or severe depression. One in 4 women and 1 in 10 men can expect to be diagnosed with depression during their lifetime. Depression costs the United States an estimated $44 billion each year. The World Health Organization predicts depression will become the leading cause of disability by the year 2020.
Lexapro and Zoloft demonstrated comparable efficacy in reducing symptoms of depression and anxiety in patients with major depressive disorder. At week eight of the study, 75 percent of Lexapro-treated patients and 70 percent of Zoloft-treated patients were considered responders, meaning they achieved a 50 percent or better reduction from baseline in their Montgomery-Asberg Depression Rating Scale (MADRS) scores. Mean changes in MADRS scores from baseline to endpoint were –19.1 and –18.4 for the Lexapro and Zoloft groups, respectively. For patients who were severely depressed at baseline (MADRS score ³ 30; N=92), mean changes in MADRS scores from baseline to endpoint were –22.4 and –20.4 for the Lexapro and Zoloft groups, respectively. Patients treated with Lexapro and Zoloft each experienced improvement in anxiety symptoms associated with depression, according to the Hamilton Rating Scale for Depression (HAM-D) Anxiety Subscale total score.
Both Lexapro and Zoloft were well tolerated in the eight-week study. Overall, about 85 percent of patients in each group completed the study. Only two and four percent of patients discontinued due to adverse events with Lexapro and Zoloft, respectively. Adverse events occurring at an incidence of >10 percent with Lexapro or Zoloft, respectively, included ejaculation disorder (23% and 23%), diarrhea (13% and 23%), nausea (17% and 17%), insomnia (14% and 17%), libido decreased (10% and 14%), upper respiratory tract infection (10% and 14%), dry mouth (4% and 14%), headache (13% and 10%), and somnolence (12% and 6%).
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Two hundred twelve patients, 18 to 80 years of age with major depressive disorder (baseline MADRS score ³ 22), participated in the double-blind study. Following a one-week, single-blind, placebo lead-in period, patients were randomized to receive either a fixed dose of 10 mg per day of Lexapro (N=104) or a flexible dose of 50 to 200 mg per day of Zoloft (N=108). If clinically indicated, Zoloft was increased in 50 mg increments each week, as recommended in the U.S. package insert. The dose could also be decreased due to tolerability concerns. The mean dose of Zoloft at week eight was 144 mg per day. The primary efficacy variable was the change in the MADRS total score from baseline to week eight. The HAM-D Anxiety Subscale was also administered at each visit.
Lexapro is the newest and fastest-growing selective serotonin reuptake inhibitor (SSRI) and is prescribed for more than three million patients in the U.S. Lexapro was developed by isolating the therapeutically active portion of the antidepressant CelexaTM (citalopram HBr).
Lexapro was approved by the U.S. Food and Drug Administration (FDA) in August 2002 for both the initial and maintenance treatment of major depressive disorder. Lexapro is available as tablets and oral solution.
As with all SSRIs, Lexapro should not be taken with monoamine oxidase inhibitors (MAOI). For more information about Lexapro, please visit http://www.lexapro.com.
Forest Laboratories licenses Lexapro from H. Lundbeck A/S, the Danish pharmaceutical firm that developed escitalopram and citalopram.
About Forest Laboratories and Its Products Forest Laboratories’growing line of products includes: LexaproTM, indicated for the initial and maintenance treatment of major depressive disorder; CelexaTM, an antidepressant; NamendaTM, an N-methyl D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe Alzheimer’s disease; Tiazac®, a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar®*, an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCTTM*, an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Aerobid®, an inhaled steroid indicated for the treatment of asthma.
Except for historical information contained herein, this release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company’s SEC reports, including the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2003, and Quarterly Reports on Form 10-Q for the periods ending June 30, 2003, and September 30, 2003. Actual results may differ materially from those projected.
* Benicar(R) and Benicar HCT(TM) are registered trademarks of Sankyo Pharma, Inc.