Forest Laboratories, Inc. (NYSE:FRX), a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market, today announced that it plans to discontinue the sale of NAMENDA® (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014. Forest has notified the U.S. Food and Drug Administration of this decision. The oral solution of NAMENDA and once-daily NAMENDA XR® (memantine HCl) 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.
"NAMENDA XR offers important benefits, including convenient, once-daily dosing, which is particularly meaningful for this patient population and their caregivers. Our decision to focus on NAMENDA XR is supported by these benefits as well as the positive feedback we've received from physicians and caregivers since the launch of NAMENDA XR," said Marco Taglietti, MD, Chief Medical officer and EVP, Drug Development and Research of Forest. "The conversion also allows us to streamline our resources and explore innovative new compounds that may be effective for the treatment of Alzheimer's disease, including the fixed-dose combination of NAMENDA XR and donepezil, which is under development."
Importantly, 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.
"Given the day-to-day challenges of caring for someone with Alzheimer's disease, there is a need for treatments that simplify a patient's daily regimen and may help caregivers manage their loved ones' needs," said Gustavo Alva, MD, Neuropsychiatrist and Medical Director at ATP Clinical Research in Costa Mesa, CA. "For many families, NAMENDA XR is already fulfilling this need as a once-a-day treatment alternative."
Forest 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.
Dr. Taglietti further noted: "Forest has provided effective treatments and education to the Alzheimer's community for the past decade, and we remain fully committed to delivering products that can improve the lives of patients and their loved ones."
Forest 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.