Namzaric Granted New Expanded Label for Alzheimer's Treatment

The FDA has approved an expanded label for memantine and donepezil hydrochlorides (Namzaric) extended-release, a once-daily, fixed-dose combination of a NMDA receptor agonist and an acetylcholinesterase inhibitor.

The FDA has approved an expanded label for memantine and donepezil hydrochlorides (Namzaric) extended-release (XR), a once-daily, fixed-dose combination of a NMDA receptor agonist and an acetylcholinesterase inhibitor (AChEI).

The new indication allows patients with moderate to severe Alzheimer’s disease who are stabilized on donepezil hydrochloride, 10 mg, (Aricept) to start combination therapy directly with Namzaric.

Around three-quarters of patients with Alzheimer’s are in the moderate to severe stages of the disease, but only one-third are on 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,” said Gavin Corcoran, MD, chief medical officer at Allergan, in a press release. “Namzaric offers the benefits of combining 2 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.”

The new indication also means Namzaric will be available in 4 dosage strengths. Patients who are currently on Aricept 10 mg will be able to start Namzaric the next day if they choose.

Namzaric’s new dosage strengths should be available in pharmacies in September 2016.

The most common adverse effects associated with Namzaric are headache, diarrhea, and dizziness. Nausea and vomiting may occur in patients for up to 3 weeks. For this reason, patients should be observed closely during this period.