Healthcare Industry News: AZOR
News Release - November 29, 2007
Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major DepressionNEW YORK, Nov. 29 (HSMN NewsFeed) -- Forest Laboratories, Inc. (NYSE: FRX ) and H. Lundbeck A/S today announced preliminary top-line results from a phase III study of LEXAPRO (escitalopram oxalate) in the treatment of adolescents, aged 12-17, with Major Depressive Disorder (MDD). These results indicate that patients treated with LEXAPRO experienced statistically significant improvement in symptoms of depression, as measured by the study's primary endpoint, the Children's Depression Rating Scale-Revised (CDRS-R), compared to placebo. 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. Additional data from this study are expected to be presented in 2008.
Researchers estimate that up to eight percent of adolescents are affected by depression.(1) However, FDA-approved treatment options for this population are limited. LEXAPRO is not currently approved by the FDA for use in pediatric patients.
"Depression is a significant problem among adolescents, and frequently goes under-recognized and under-treated in this age group. These data support that LEXAPRO has potential as an effective treatment option for adolescents with depression," said Ivan Gergel, M.D., Senior Vice President of Scientific Affairs and President of the Forest Research Institute.
About the Study
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. During the eight week study, 316 patients were randomized to receive 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 study showed statistically significant improvement in patients treated with LEXAPRO relative to placebo (p=0.022).
The trial also showed that LEXAPRO was generally well-tolerated. Overall premature discontinuation rates (all causes including adverse events) were [19%] for patients receiving LEXAPRO and [15%] for patients receiving placebo.
Future Development Plans
"Based on these positive results and results of other studies, we see potential for LEXAPRO, already established as an effective treatment for adults with depression, as a treatment for adolescents with MDD. Subject to ongoing communication with the FDA and our review of the full study results for the just completed trial, we intend to file in 2008 for an adolescent depression indication for LEXAPRO," said Ivan Gergel, M.D.
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss of interest in usual activities.(3) While the brain chemistry of depression is not fully understood,(4) research suggests that depression is caused by an imbalance of certain chemicals in the brain, most notably serotonin.(5)
Despite advances and progress in identifying and treating mental disorders in adolescents, epidemiologic studies indicate that only 20-35 percent of depressed patients in this age group currently receive treatment.(6) Depression is a chronic disease(3) that requires medical attention and treatment, and if left untreated, may have serious consequences.(7)
For adolescents who suffer from depression, psychotherapy, cognitive- behavior therapy, interpersonal therapy and medication play an important role in the management of their illness.(2) 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 in depression and low in the treatment of GAD. LEXAPRO has been prescribed to over 16 million people.(11)
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 in 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, or in patients with a hypersensitivity to escitalopram oxalate. 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. The most common adverse events reported with LEXAPRO vs 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 (www.frx.com) is a U.S.-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® (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda® (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; and Campral®* (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. In addition to our growing product line, Forest also co-promotes the Daiichi Sankyo, Inc. products Benicar®* (olmesartan medoxomil), an angiotensin receptor blocker, Benicar HCT®* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, and AZOR(TM)* (amlodipine and olmesartan medoxomil) a calcium channel blocker and angiotensin receptor blocker combination product, all indicated for the treatment of hypertension.
*AZOR is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are registered trademarks 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 form time to time in the Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
1. Jellinek MS, Snyder JB. Depression and suicide in children and adolescents. Pediatr Rev 1998;19: 255-64. Birmaher B, Brent D, et al. Practice parameters for the assessment and treatment of children and adolescents with depressive disorders. J Am Acad Child Adolesc Psychiatry. 1998;37(suppl 10):63S-82S.Note: securing primary source
2. Bhatia, MD S.K., Bhatia, MD S.C., Childhood and Adolescent Depression. American Family Physician. 2007:Volume 75, Number 1
3. National Institute of Mental Health. Depression. Accessed November 1, 2007, at http://www.nimh.nih.gov/health/topics/depression/index.shtml
4. Mayo Clinic. Depression. Accessed November 1, 2007, at http://www.mayoclinic.com/health/depression/DS00175/DSECTION=3Paragraph2
5. Mayo Clinic. Depression. Accessed November 1, 2007, at http://www.mayoclinic.com/health/depression/DS00175/DSECTION=3Paragraph 1
6. Burns BJ, Costello EJ, Angold A, et al. Children's mental health service use across service sectors. Health Aff (Millwood).1995;14:147- 159. Leaf PJ, Alegria M, Cohen P, et al. Mental health service use in the community and schools: results from the four-community MECA Study. Methods for the Epidemiology of Child and Adolescent Mental Disorders Study. J Am Acad Child Adolesc Psychiatry. 1996;889-897. Note: securing primary source
7. Mayo Clinic. Depression. Accessed November 1, 2007, at http://www.mayoclinic.com/health/depression/DS00175/DSECTION=7 Complications section, Paragraph 1
8. Grunbaum JA, Kann L, Kinchen SA, Williams B, Ross JG, Lowry R, et al. Youth risk behavior surveillance - United States, 2001. MMWR Surveill Summ 2002; 51:1-62
9. Anderson RN. Deaths: leading causes for 2000. Natl Vital Stat Rep 2002:50:1-85
10. Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Erkens JA, Herings RM, Mann JJ. Early Evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry. 2007 Sep; 164(9):1356-63
11. Wolters Kluwer Health. LEXAPRO projected Unique Patient Counts Since Launch. August 2007.
Source: Forest Laboratories
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