FDA approves expanded label for Namzaric in Alzheimer’s disease
Posted: 20 July 2016 | | No comments yet
The US Food and Drug Administration (FDA) has approved an expanded label for Namzaric.
Namzaric is a once-daily, fixed-dose combination of memantine hydrochloride, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor
With the new indication, patients with moderate to severe Alzheimer’s disease, who are currently stabilised 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.
Gavin Corcoran, M.D., chief medical officer at Allergan, explained more about the potential of 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.”
Efficacy based on results of a trial of 677 Alzheimer’s disease patients
The efficacy and safety of the co-administration of memantine HCl extended release and acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a trial of 677 patients with moderate to severe Alzheimer’s disease on a stable dose of AChEIs. The clinical study was not conducted with Namazaric; however, bioequivalence of Namzaric with co-administered memantine HCl extended release and donepezil HCl was demonstrated. Approximately 68% of the patients randomised to receive either memantine HCl extended release 28 mg or placebo were taking donepezil as the AchEI at Baseline and throughout the study. The results of this study demonstrated statistically significant improvement in cognition and global function for patients treated with memantine HCl extended release 28 mg plus an AChEI compared to placebo plus an AchEI at 24 weeks.
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 next day.
In addition to the two currently available dosage strengths, the two new Namzaric dosage strengths will be available in pharmacies in September.
Allergan and Adamas collaborated on the development of the fixed-dose combination and Allergan owns the exclusive US commercialisation rights, while Adamas will retain exclusive commercialisation rights outside of the US.