Forest And Merz Announce FDA Approval Of Namenda XR For The Treatment Of Moderate To Severe Dementia Of The Alzheimer's Type

Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced that Namenda XR(TM) (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%).


Source:

Merz Pharmaceuticals

Forest Laboratories


View drug information on Namenda.