FDA Approves Namenda XR
Forest and Merz Announce FDA Approval of Namenda XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type
NEW YORK--(BUSINESS WIRE)--Jun 21, 2010 - Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that Namenda XR (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda XR is a 28 mg once-daily extended-release formulation of Namenda. The safety and efficacy of Namenda XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with Namenda XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.
Namenda XR will be covered by U.S. Patent No. 5,061,703, which is listed in the Orange Book for Namenda and expires in April 2015. In addition, Forest owns pending patent applications related to Namenda XR. The companies are determining the appropriate commercialization strategy and market timing to ensure a successful franchise.
About Namenda XR
Namenda XR (memantine HCl) extended release capsules are a 28mg once-daily formulation of Namenda approved for the treatment of moderate to severe dementia of the Alzheimer's type. Namenda, a twice daily immediate release formulation, was approved in October 2003. Namenda XR has a mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease.
Important Safety Information
Contraindications
- Namenda XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.
Precautions
- Caregivers should be instructed in the recommended administration (once per day) and about dose escalation (minimum interval of one week between dose increases).
- Namenda XR has not been systematically evaluated in patients with a seizure disorder.
- Namenda XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels.
- A dosage reduction is recommended in patients with severe renal impairment.
- Namenda XR should be administered with caution to patients with severe hepatic impairment.
Adverse Reactions
- In clinical trials, the most common adverse events occurring in at least 5% of patients treated with Namenda XR and at a greater frequency than placebo-treated patients were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
About Merz
Merz Pharmaceuticals researches, develops, produces and distributes innovative pharmaceutical products in the areas of neurology and psychiatry as well as in aesthetic dermatology and metabolism. In the area of Alzheimer's research, Merz Pharmaceuticals has achieved a leading position with the first active ingredient worldwide for the treatment of moderate to severe Alzheimer's disease. The Company is headquartered in Frankfurt am Main, Germany. To learn more about Merz, visit www.merz.com.
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.
Contact: Forest Laboratories, Inc.
Frank J. Murdolo
Vice President - Investor Relations, Forest Laboratories,
Inc.
1-212-224-6714
Frank.Murdolo@frx.com
Posted: June 2010
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