FDA Approves Lexapro Oral Solution
Lexapro Oral Solution Formulation Provides New Option for Depressed Patients
NEW YORK, Dec. 2 /PRNewswire-FirstCall/ -- Forest Laboratories Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration approved for marketing an oral solution of Lexapro (escitalopram oxalate). Lexapro, a selective serotonin reuptake inhibitor (SSRI), is the single isomer of Celexa(TM) (citalopram HBr). Lexapro was approved in August 2002 by the FDA for the treatment of major depressive disorder and maintenance treatment. The oral solution of Lexapro will be available commercially by first quarter 2003 and will provide an added convenience and ease of use for certain patients.
The New Drug Application (NDA) for the oral solution was submitted on November 2, 2001. Like the tablet formulation, the oral solution of Lexapro is a safe and effective treatment for major depressive disorder. In clinical trials, many patients taking Lexapro 10 mg per day demonstrated a significant improvement in depressive symptoms beginning at the first or second week of treatment. Additionally, Lexapro dropout rates due to adverse events and the overall incidence of side effects for the 10 mg daily dose were comparable to placebo in the studies. Lexapro also has a low risk of drug-drug interactions. The most common adverse events reported with Lexapro were nausea, insomnia, ejaculation disorder, somnolence, sweating increased and fatigue.
Due to the ease of administration, Lexapro oral solution will provide treatment benefits to a wider range of patients, including the elderly and others who have difficulty swallowing tablets.
About Lexapro: An Isomer of Celexa
Lexapro is the product of a relatively new approach that involves the removal of one of two enantiomers from Celexa to create a single-enantiomer drug. Celexa is a racemic mixture of two mirror-image halves called the S- and R-enantiomers. With Lexapro, the R-enantiomer (that does not contribute to Celexa's antidepressant activity) has been removed, leaving only the therapeutically active S-enantiomer. For more information on Lexapro, visit http://www.lexapro.com .
Forest Laboratories licensed Lexapro from the Danish pharmaceutical firm H. Lundbeck A/S, which developed both citalopram and escitalopram in Europe.
About Forest Laboratories and Its Products
Forest Laboratories develops, manufactures, and sells ethical pharmaceutical products that are used for the treatment of a wide range of illnesses. Forest's growing line of products includes: Lexapro(TM), indicated as initial as well as maintenance treatment of major depressive disorder; Celexa(TM), indicated for the treatment of depression; Tiazac(R), a once-daily diltiazem, which is indicated for the treatment of angina and hypertension; and Aerobid(R) an inhaled steroid indicated for the treatment of asthma. The Company has also entered into a co-promotion agreement with Sankyo of Japan for the marketing of Benicar(TM)* for the treatment of hypertension.
Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation 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, 2002 and Quarterly Reports on Form 10-Q for the period ended June 30, 2002 and September 30, 2002. Actual results may differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma.
Posted: December 2002
- Forest Laboratories, Inc. Announces FDA Approval of Lexapro for the Treatment of Major Depressive Disorder in Adolescents - March 20, 2009
- Lexapro Receives FDA Approval for the Treatment of Generalized Anxiety Disorder - December 18, 2002
- Lexapro Approved as Maintenance Treatment for Major Depressive Disorder - August 29, 2002
- Lexapro, The Single-Isomer of Celexa, Receives FDA Approval For the Treatment of Major Depression - August 15, 2002