Allergan plc (NYSE: AGN) and Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS), announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC®(memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
With the new indication, patients with moderate to severe Alzheimer’s disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with NAMZARIC. Approximately 75% of patients diagnosed with Alzheimer’s Disease are in the moderate to severe stage of the disease and yet only about one-third of these patients are treated with combination therapy.
“Clinical studies have shown that combination therapy with Namenda XR and an AChEI such as Aricept demonstrated greater improvement in cognition and global function verses an AChEI alone. NAMZARIC offers the benefits of combining two products that each work differently to treat moderate to severe Alzheimer’s disease while at the same time reducing the number of pills a patient and their caregivers need to administer each day,” says Gavin Corcoran, M.D., chief medical officer atAllergan. “At Allergan, we’re proud to continue developing products and supporting new programs that can help patients and their caregivers as they navigate this complex disease.”
With the new, expanded indication, NAMZARIC will be available in four dosage strengths which allows patients currently taking Aricept 10mg to start on NAMZARIC the very next day. Namzaric is covered broadly by Medicare Part D prescription plans.
In addition to the two currently available dosage strengths, the two new NAMZARIC dosage strengths will be available in pharmacies in September.