Phase III Data Presented at American Psychiatric Association Annual Meeting
WASHINGTON, May 7 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) announced today that study results show Lexapro (escitalopram oxalate) significantly improved symptoms of depression as compared to placebo treatment and was well tolerated in adolescents, aged 12-17, with major depressive disorder (MDD), according to phase III data presented at the 2008 Annual Meeting of the American Psychiatric Association. These results suggest that Lexapro has potential as a useful treatment option for adolescents with depression. Top-line results of this study were initially released in November 2007.
"Treating depression in adolescents can be particularly challenging because few antidepressants have demonstrated efficacy in clinical trials in this population," said Graham Emslie, MD, Professor of Psychiatry at the University of Texas Southwestern Medical Center in Dallas. "In this study, Lexapro significantly improved depressive symptoms in adolescents with MDD, and was also well tolerated by study participants."
Researchers estimate that up to eight percent of adolescents are affected by depression. Depression is a chronic disease that requires medical treatment. However, FDA-approved treatment options for this population are limited. Lexapro is not currently approved by the FDA for use in pediatric or adolescent patients.
Based on the results of this study, Forest plans to file for an adolescent depression indication for Lexapro this year.
A double-blind, parallel-group, placebo-controlled phase III study to evaluate the safety and efficacy of Lexapro in the treatment of depressed adolescents, aged 12-17, was conducted in multiple centers across the U.S. A total of 316 patients entered the eight week study, receiving either Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was change from baseline to Week 8 on the Children's Depression Rating Scale - Revised (CDRS-R) using last observation carried forward (LOCF) approach. The CDRS-R is a commonly used clinician-rated instrument that covers 17 symptom areas of depression relevant to adolescents, including impaired schoolwork, difficulty having fun, social withdrawal, physical complaints, and low self-esteem. The study showed statistically significant improvement in patients treated with Lexapro relative to placebo based on the change from baseline in the CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated. Discontinuation rates due to adverse events were 2.6 percent and 0.6 percent for patients receiving Lexapro and placebo, respectively. Serious adverse events were reported by 2.6 percent of patients receiving Lexapro and 1.3 percent for patients receiving placebo. The most commonly reported adverse events (greater than 10 percent in either group) were headache (25 percent in Lexapro patients vs. 26 percent with placebo), menstrual cramps (11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury (9 percent vs. 13 percent placebo), the majority of which were accidental in nature. The only adverse event occurring at a frequency of greater than or equal to 5 percent and with an incidence for Lexapro treated patients twice that of placebo treated patients was influenza-like symptoms (7 percent vs. 3 percent placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss of interest in usual activities. While the brain chemistry of depression is not fully understood, research suggests that depression is caused by an imbalance of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental disorders in adolescents, depression in this population remains under-treated. Depression is a chronic disease that requires medical attention and treatment, and if left untreated, may have serious consequences. According to the National Alliance on Mental Illness (NAMI), adolescents with untreated depression are likely to have ongoing problems in school, at home and with their friends.
For adolescents who suffer from depression, psychotherapy, cognitive-behavior therapy, interpersonal therapy and medication play an important role in the management of their illness. Patients on antidepressant treatment should also be closely monitored by healthcare providers, family members and other caregivers.
Lexapro is an SSRI being studied as a treatment for adolescents with MDD. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder (GAD) in adults. Lexapro is thought to work by helping to restore the brain's chemical balance. It is believed to increase the availability of serotonin, a substance in the brain believed to influence mood. In adults, Lexapro 10 mg/day is a well-tolerated therapy, with drop-out rates due to adverse events comparable to placebo treatment in depression trials. Lexapro has been prescribed to over 16 million people.
Important Lexapro Information
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Antidepressants increased the risk of suicidality (suicidal thinking and behavior) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of antidepressants in children, adolescents or young adults must balance the risk to clinical need. Patients of all ages started on antidepressant therapy should be closely monitored and observed for clinical worsening, suicidality or unusual changes in behavior, especially at the beginning of therapy or at the time of dose changes. This risk may persist until significant remission occurs. 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.
Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), pimozide (see DRUG INTERACTIONS - Pimozide and Celexa), or in patients with hypersensitivity to escitalopram oxalate. As with other SSRIs, caution is indicated in the coadministration of tricyclic antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) and other psychotropic drugs that interfere with serotonin reuptake may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin and other anticoagulants may add to the risk. Patients should be cautioned about these risks. SSRIs and SNRIs have been associated with clinically significant hyponatremia. Elderly patients or patients taking antidiuretics or who are otherwise volume-depleted appear to be at a greater risk. Discontinuation of Lexapro should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. The most common adverse events with Lexapro versus placebo (approximately 5 percent or greater and approximately twice that of placebo) were nausea, insomnia, ejaculation disorder, somnolence, increased sweating, fatigue, decreased libido, and anorgasmia. Further information on Lexapro is provided in the FDA approved Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in people's lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial 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; 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; and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking agent indicated for the treatment of hypertension. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. product Azor(TM)* (amlodipine and olmesartan medoxomil), a calcium channel blocker and angiotensin receptor blocker combination product indicated for the treatment of hypertension. For more information, visit http://www.frx.com.
* Azor is a trademark of Daiichi Sankyo, Inc. and Campral is a registered trademark of Merck Sante s.a.s., a 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' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
|SOURCE Forest Laboratories, Inc.|
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