Forest Laboratories, Inc. announced today that NAMENDA XR (TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer’s type. New NAMENDA XR 28 mg is a higher dose, once-daily extended-release formulation of NAMENDA (memantine) immediate-release. The efficacy and safety of NAMENDA XR was established in a randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl). AChEIs are a different class of prescription drugs often used in combination with NAMENDA for the treatment of moderate to severe Alzheimer’s disease. The results of this study, demonstrated statistically significant improvement in cognition and global function for patients treated with NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery (2.6 unit mean difference). Global function was measured by the Clinician’s Interview-Based Impression of Change (0.3. unit mean difference). NAMENDA XR was studied in combination with commonly prescribed AChEIs (donepezil, galantamine, or rivastigmine). Namenda XR can be used alone or added to other acetylcholinesterase inhibitors The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%). “We are pleased to be introducing NAMENDA XR so that patients can benefit from the convenience of a once-daily regimen that aligns with once-daily AChEIs,” said Dr. Marco Taglietti, President Forest Research Institute. “The NAMENDA XR study supports the existing body of evidence that memantine provides cognitive and global benefits in patients with moderate to severe Alzheimer’s disease either alone or with an AChEI.”
“Caring for a loved one with moderate to severe Alzheimer’s is a daily challenge, especially when a caregiver is responsible for administering as many as nine prescription medications every day,” said John Schall, President and CEO of the Caregiver Action Network (CAN). “Treatment options that could help lessen this burden may be a welcome relief for the millions of caregivers across the U.S. who are already managing with multiple tasks on a daily basis.”About Namenda XR NAMENDA XR (memantine HCl) is a higher dose, once-daily formulation of Namenda immediate release that was studied with commonly prescribed acetylcholinesterase inhibitors. Its unique mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. Indicated for the treatment of moderate to severe dementia of the Alzheimer’s type, the FDA approved NAMENDA XR based on demonstrated statistically significant improvements in cognition and global function for patients treated with NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI. There is no evidence that NAMENDA XR or an AChEI prevents or slows the underlying disease process in patients with Alzheimer’s disease. Visit NamendaXR.com for more information about this new once-daily treatment regimen. NAMENDA XR TM (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Important Safety Information Contraindications • NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Warnings and Precautions • 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 and a possible increase in adverse effects. • NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.
Drug Interactions• No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution. About Forest Laboratories, Inc. Forest Laboratories' (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, 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 Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.