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Depressed Patients Showed Improvement with Lexapro(TM) After Failure with Initial SSRI Treatment

Category:

Thursday, May 6, 2004 8:08 am EDT

Dateline:

NEW YORK

Public Company Information:

NYSE:
FRX

Forest Laboratories, Inc. (NYSE: FRX) today announced the results of a clinical study, which found that Lexapro(TM) (escitalopram oxalate) is a beneficial and well-tolerated treatment for depressed patients who failed to respond to initial antidepressant therapy with any one of four other selective serotonin reuptake inhibitors (SSRIs). In addition, 60 percent of patients who were switched to Lexapro responded and more than 40 percent achieved remission of depressive symptoms after failing initial antidepressant therapy. The findings were presented at the 157th annual meeting of the American Psychiatric Association in New York.

"Forty percent of patients achieving remission from Lexapro after not responding to another SSRI is remarkable," said Dan L. Zimbroff, M.D., lead study investigator and medical director of the Pacific Clinical Research Medical Group in San Bernardino, California. "These results bring hope for both doctors and patients who have experienced difficulty in finding an effective treatment option."

Depression affects nearly 19 million adult Americans and costs the United States an estimated $44 billion each year. Symptoms of depression often include frequent feelings of worthlessness or guilt, difficulty concentrating, loss of interest in activities, and a change in eating or sleeping habits. The World Health Organization predicts depression will become the leading cause of disability by the year 2020.

Study Conclusions

At the end of the eight-week treatment period, Lexapro was shown to be beneficial and well tolerated in patients who did not respond to initial SSRI therapy, including Zoloft(R) (sertraline hydrochloride), Prozac(R) (fluoxetine hydrochloride), Celexa(TM) (citalopram HBr), and Paxil(R)(paroxetine hydrochloride). Approximately 60 percent of previously, non-responding patients met the criteria for response and more than 40 percent achieved remission of depressive symptoms when treated with Lexapro. Regardless of which SSRI treatment patients were started on, Lexapro was beneficial in achieving response and remission. Remission was defined as a MADRS score of less than or equal to 10 and represents a resolution of depressive symptoms and restoration of normal functioning.

In the study, non-responders to initial SSRI therapy were safely switched to Lexapro within 24 hours. Lexapro was well tolerated, with only 6.6 percent of patients withdrawing from the study due to adverse events associated with Lexapro treatment, following therapy with another SSRI. Headache was the only adverse event reported by more than 10 percent of the patients treated with Lexapro following treatment with another SSRI.

Study Methodology

Five hundred and fifteen patients, ages 18 to 65 with major depressive disorder (baseline MADRS score greater than or equal to 22), participated in an eight-week, lead-in treatment period with an initial SSRI. Patients were randomized to receive open-label, flexible dose treatment of citalopram (20-60 mg per day; N=131), sertraline (50-200 mg per day; N=127), paroxetine (20-50 mg per day; N=128), or fluoxetine (20-80 mg per day; N=129). At the end of the lead-in period, 137 patients who completed the trial and did not respond to initial treatment (MADRS >12) participated in an eight-week, open-label trial of Lexapro at 10-20 mg per day. Patients were switched to Lexapro within 24 hours of discontinuing initial treatment. Response at the end of the lead-in treatment period was defined as a MADRS score less than or equal to 12. At the end of the Lexapro treatment period, response was defined as at least a 50 percent reduction in MADRS scores from the beginning of the lead-in treatment period. Remission was defined as a MADRS score of less than or equal to 10.

About Lexapro

Lexapro is the newest and fastest-growing selective serotonin reuptake inhibitor (SSRI) and has been prescribed for more than 4.5 million patients in the U.S.

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 and in December 2003 for the treatment of generalized anxiety disorder. Lexapro is available as tablets and oral solution.

As with all SSRIs, Lexapro should not be taken with monoamine oxidase inhibitors (MAOI). 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 antidepressants in inducing 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.

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: Lexapro(TM), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Celexa(TM), an antidepressant; Namenda(TM), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar(R),* an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT (TM), an angiotensin receptor blocker and diuretic combination product indicated for the second- line treatment of hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment of asthma.

* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.

Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities 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 Report on Form 10-Q for the period ended June 30, 2003, September 30, 2003, and December 31, 2003. Actual results may differ materially from those projected.