Forest Labs To Discontinue Sale Of NAMENDA Tablets Effective Aug. 15, 2014

(RTTNews) - Forest Laboratories, Inc. (FRX) announced that it plans to discontinue the sale of NAMENDA 5 mg and 10 mg tablets effective August 15, 2014 and it has notified the U.S. Food and Drug Administration of this decision.

The company said the oral solution of NAMENDA and once-daily NAMENDA XR extended-release capsules will continue to be available. Both NAMENDA and NAMENDA XR are indicated for the treatment of moderate to severe Alzheimer's disease.

Forest stated that the important thing is that physicians can switch patients from NAMENDA to NAMENDA XR the very next day without titration, as outlined in the FDA-approved package insert. In addition to its convenient dosing, NAMENDA XR capsules can be opened and the contents sprinkled on applesauce for patients who have difficulty swallowing pills.

Forest said it had sponsored a third-party survey that included 250 physicians treating Alzheimer's patients and 250 caregivers of Alzheimer's patients. Physicians surveyed responded that NAMENDA XR once daily administration was important in their decision to prescribe the medication. Also, a majority of caregivers responded that they were satisfied with the once daily dosing of NAMENDA XR.

The company said it is actively communicating with healthcare providers, pharmacists, patients, and caregivers to notify them of the discontinuation of NAMENDA and the continued availability of NAMENDA XR.

Commenting on NAMENDA XR, the company said its mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of NAMENDA XR was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors or AchEl.

It is noted that there is no evidence that NAMENDA XR or an AChEI prevents or slows the underlying disease process in patients with Alzheimer's disease.