NEW YORK--(BUSINESS WIRE)--Forest Laboratories announced that it intends to completely convert its line of Namenda pills for Alzheimer's to the extended-release NAMENDA XR® product later in the year.
Forest Labs will continue to market both its NAMENDA® (memantine HCl) 5 mg and 10 mg tablets and once-daily NAMENDA XR® (memantine HCl) extended-release capsules into the fall of 2014. The Company noted that patient and caregiver response to the NAMENDA XR® product has been exceptionally positive, with caregivers and physicians clearly recognizing the benefits of the single daily dosing regimen. Forest stated that its decision to defer final conversion to the NAMENDA XR® product later in the year will not affect the company’s ability to meet its financial objectives for the product.
“The conversion to the single daily dose has exceeded our expectations with current scripts trending at approximately 40% for NAMENDA XR®,” said Brent Saunders, Forest’s CEO and President. “We have always maintained that the successful conversion to Namenda XR® is based on three things: Patient, caregiver and healthcare providers responding favorably to the benefits of the once-daily dosing of the NAMENDA XR® product; ensuring that we achieved appropriate levels of managed care coverage and formulary planning; and ensuring that we optimize the efficiency of our manufacturing capabilities to ensure adequate supply to support the ultimate conversion to the XR product. Conversion rates are demonstrating patient and payer acceptance of the benefits of the single daily dose, and we continue to make progress in improving manufacturing yield and efficiency. The success of the NAMENDA XR® conversion to date provides us with the option of adjusting the timing of the final conversion, while still meeting our financial commitments.”
About NAMENDA XR®NAMENDA XR® (memantine HCl) extended release capsules are a higher dose, once-daily formulation of NAMENDA® immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. 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 (AChEl).
NAMENDA XR® 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician’s Interview-Based Impression of Change Scale (0.3. unit mean difference).