Allergan (AGN), Adamas Pharma (ADMP) Announces Availability of NAMZARIC, Donepezil Dosage Strengths

September 22, 2016 8:04 AM EDT

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Allergan plc (NYSE: AGN), and Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) announced that all four dosage strengths of NAMZARIC (memantine and donepezil hydrochlorides) extended-release capsules that allow patients on donepezil 10 mg to start directly on NAMZARIC are now available by prescription in pharmacies throughout the U.S. NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI) for the treatment of moderate to severe Alzheimer's Disease in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC'S new indication and dosage strengths were approved by the U.S. Food and Drug Administration (FDA) in July 2016.

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 significantly superior improvement in cognition and global function verses an AChEI alone.

"We are excited that with the new available dosage strengths 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. NAMZARIC offers these patients the benefits of combining two products that each work differently to treat moderate to severe Alzheimer's disease, without increasing the number of pills a patient and their caregiver need to administer each day," said Gavin Corcoran, M.D., chief medical officer at Allergan. "This launch reinforces Allergan's commitment to development of treatments for Alzheimer's Disease and other neurological disorders."

NAMZARIC will be commercially available in 30 count bottles in 7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg and 28 mg/10 mg. NAMZARIC is covered broadly by Medicare Part D prescription plans.

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