Lexapro(R) Demonstrated Significance on Prospectively Defined Efficacy Parameter and Was Better Tolerated Than Cymbalta(R) in Treatment of Depression

NEW YORK, Dec. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc., today announced the results of a new study demonstrating that Lexapro (escitalopram oxalate) provided a greater reduction in MADRS scores, (p=0.040), utilizing an LOCF approach and was better tolerated than Cymbalta (duloxetine), based on the percentage of patients discontinuing treatment due to adverse events, in the treatment of patients with moderate to severe major depressive disorder (MDD).

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Dr. Arif Kahn, Medical Director of Northwest Clinical Research Center and investigator in this study said, "These findings add to a number of studies that demonstrate the clinical value of Lexapro in the treatment of depression."

Study details

Patients (aged 18-80 years) with DSM-IV diagnosed MDD as determined by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 26 or greater were randomized to eight weeks of double-blind treatment with Lexapro 10-20 mg/day (dose fixed at 10 mg/day for the first four weeks with optional up-titration to 20 mg/day thereafter) or Cymbalta 60 mg/day. Dosing of the two antidepressants was consistent with information in the FDA-approved package inserts of both drugs. The primary, prospectively-defined, efficacy endpoint was the change from baseline at week eight in the MADRS total score, using the last observation carried forward (LOCF) approach. At the start of the study, 137 patients were enrolled in the Lexapro arm of the study and 133 in the Cymbalta arm.

At the end of the eight-week study, Lexapro patients demonstrated greater improvement than Cymbalta patients in total MADRS score (LSMD, least squared mean difference, -2.42 [95% CI: -4.73, -0.11]; p=0.040). The proportion of patients responding to Lexapro treatment, as determined by a 50 percent improvement in MADRS total score, also was greater when compared to patients in the Cymbalta group (68 percent vs 52 percent, p=0.011; LOCF). Remission rates were 44 percent in the Lexapro group and 38 percent in the Cymbalta group, as determined by a total MADRS score of 10 or less, this difference was not significant. The rate of improvement on the MADRS was similar between the groups when an observed cases analysis was conducted. In addition, there was no difference seen between the group on a number of measures of relief of somatic and pain-related symptoms.

More patients in the Lexapro group completed eight weeks of treatment than patients in the Cymbalta group (87 percent vs 69 percent, p=0.001), and fewer patients receiving Lexapro discontinued treatment due to adverse events compared to patients receiving Cymbalta (2 percent vs 13 percent, p=0.001).

About Lexapro

Lexapro is a selective serotonin reuptake inhibitor (SSRI) that has been prescribed for more than 14 million adult patients in the United States.

Lexapro was approved by the U.S. Food and Drug Administration in August 2002 for both the initial and maintenance treatment of major depressive disorder (MDD) in adults, and in December 2003 for the treatment of Generalized Anxiety Disorder (GAD) in adults.

The most common adverse events reported with Lexapro (reported at rates of approximately 5 percent or greater and 2 times or more the incidence seen in the placebo group) were nausea, insomnia, ejaculation disorder, somnolence, increased sweating, fatigue, decreased libido, and anorgasmia. Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), pimozide, or in patients with a hypersensitivity to escitalopram oxalate or any of the ingredients in Lexapro.

As with other SSRIs, caution is indicated in the coadministration of tricyclic antidepressants (TCAs) with Lexapro. As with other psychotropic drugs that interfere with serotonin reuptake, patients should be cautioned regarding the risk of bleeding associated with the concomitant use of Lexapro with NSAIDs, aspirin, or other drugs that affect coagulation.

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

Although no causal role for such behaviors has been established, patients being treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients.

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 (http://www.frx.com/) is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the internal and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotenisn receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.

* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.

Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in the Forest Laboratories' SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for the periods ended June 30 and September 30, 2006.