Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents
NEW YORK, March 20, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 - 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the U.S.
(LOGO: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO)
"Major depressive disorder in adolescents is a debilitating, but treatable illness," said Howard Solomon, Chairman and Chief Executive Officer, of Forest. "We have long believed that Lexapro would be of benefit for the treatment of depression in adolescents and that is why we undertook the several studies described in the package insert. We are enormously gratified that Lexapro will be available for depressed adolescents who so much require the benefits which Lexapro has made available for depressed adults for the past seven years."
Study Results
The approval of Lexapro for the treatment of adolescent depression was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram. In an 8-week flexible- dose, placebo-controlled study that compared Lexapro 10-20 mg/day to placebo in 12 to 17 year old patients reported in 2008, Lexapro showed statistically significant greater mean improvement from baseline, compared to placebo, on the Children's Depression Rating Scale-Revised (CDRS-R).
In another 8-week, flexible-dose, placebo-controlled study, children and adolescents 7 to 17 years of age treated with racemic citalopram 20-40 mg/day showed statistically significant greater mean improvement from baseline on the CDRS-R compared to patients treated with placebo. The positive results for this trial largely came from the adolescent subgroup. The FDA's determination of the efficacy of Lexapro in the acute treatment of MDD in adolescents was established, in part, on the basis of extrapolation from this study.
Two additional flexible-dose, placebo-controlled MDD studies were conducted: one Lexapro study in patients ages 7 to 17 and one citalopram study in adolescents. Neither study demonstrated efficacy on the primary efficacy parameter.
Although maintenance efficacy in adolescent patients has not been systematically evaluated, the FDA in its review concluded that maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.
Lexapro was generally well tolerated. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert.
"Adolescent depression can often be challenging to treat because there are limited treatment options that are proven to be effective and well-tolerated in this patient population," said Graham Emslie, MD, Professor of Psychiatry at the University of Texas Southwestern Medical Center in Dallas. "The FDA approval of Lexapro for adolescents is a significant development for the patients who struggle with this illness every day.
Depression and Adolescents
Depression in adolescents, as in adults, is a serious disease that requires medical treatment. Approximately 2 million U.S. adolescents aged 12 to 17 have suffered a serious bout of depression in the past year, according to a recent national survey conducted by the Substance Abuse and Mental Health Services Administration. Adolescent depression is characterized by persistent sadness or irritability or loss of interest in usual activities. For adolescents who suffer from depression, talk therapy and medication can 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.
About Lexapro
Lexapro is indicated for the acute and maintenance treatment of MDD in adults and adolescents (aged 12-17) and for acute treatment of 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 thought to influence mood. Since its launch in 2002, Lexapro has been prescribed to more than 18 million patients in the U.S.
IMPORTANT SAFETY INFORMATION
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of therapy or at times 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 less than 12 years of age.
Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), pimozide, or in patients with hypersensitivity to escitalopram or citalopram. As with other SSRIs, caution is indicated in the coadministration of tricyclic antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) may increase the risk of bleeding events. Patients should be cautioned that concomitant use of aspirin, NSAIDs, warfarin and other anticoagulants may add to the risk.
Lexapro is not approved for use in treating bipolar depression. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Lexapro should be used cautiously in patients with a history of mania or with a history of seizure disorder. Lexapro should be used with caution in patients with severe renal impairment or with diseases or conditions that produce altered metabolism or hemodynamic responses.
SSRIs and SNRIs have been associated with clinically significant hyponatremia. Elderly patients or patients taking diuretics 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 concomitant use of Lexapro with other SSRIs, SNRIs, triptans, tryptophan, antipsychotics or other dopamine antagonists is not recommended due to the potential for development of life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions. The management of these events should include immediate discontinuation of Lexapro and the concomitant agent and continued monitoring.
Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Lexapro therapy does not affect their ability to engage in such activities.
For pregnant and nursing mothers, Lexapro should be used only if the potential benefit justifies the potential risk to the fetus or child.
Patients should be monitored for adverse reactions when discontinuing treatment with Lexapro. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.
The most common adverse reactions in adults treated with Lexapro (approximately 5% or greater and at least twice the incidence of placebo) are nausea, insomnia, ejaculation disorder, fatigue and somnolence, increased sweating, decreased libido, and anorgasmia. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert. Other adverse reactions that were reported in the pediatric trials at an incidence of at least 2% for Lexapro treated patients and greater than that in the placebo treated patients were back pain, urinary tract infection, vomiting, and nasal congestion.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
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 Forest Laboratories' Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.