Rx May Reduce Agitation in Alzheimer's Patients

AVP 923 reduced agitation in Alzheimer patients in phase II trial

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Alzheimer's patients often become upset or afraid in new situations. But a new medicine may be able to reduce this agitation.

Avanir Pharmaceuticals announced the results of a phase II trial for AVP-923 today. 

The medicine, already approved under the brand name Nuedexta to treat sudden, intense emotional episodes, reduced agitation in Alzheimer's patients more than a placebo, said an Avanir press release.

"Talk to your neurologist about ways to treat Alzheimer's symptoms."

"With no [US Food and Drug Administration] approved drugs for the treatment of agitation in Alzheimer's disease, we believe these results represent a breakthrough for patients," said Joao Siffert, MD, Avanir's chief medical officer.

Alzheimer's disease affects around 6 million US patients. It is a form of dementia marked by impaired memory and trouble with daily tasks. Agitation is a common symptom.

"Nuedexta (dextromethorphan/quinidine) is already approved by the FDA for treatment for pseudobulbar affect (PBA), a neurological disorder characterized by sudden, unpredictable episodes of crying and/or laughing," said E. Lee Carter, RPh, Clinical Pharmacy Specialist at the Department of Veterans Affairs in Prestonsbrug, Kentucky. "PBA occurs in people with neurological diseases and conditions such as Alzheimer's, brain injury or stroke."

According to Carter, "Neudexta, also known experimentally as AVP-923, is showing promise in the treatment of agitation in patients diagnosed with Alzheimer’s disease. There are currently no FDA-approved pharmaceuticals for the treatment of agitation associated with Alzheimer's disease, so AVP-923 could represent a significant breakthrough for patients and their caregivers who deal with the effects of Alzheimer's on a daily basis."

Carter further explained, "Avanir Pharmaceuticals reported in 2013 that the FDA had agreed to 'fast track' this medication if studies supported its use in Alzheimer's agitation, providing hope that this treatment option could be in the hands of clinicians sooner than the usual time period for FDA approval (which normally includes several years of patient trials and subsequent interpretation of data)."

AVP-923 is a mixture of two medicines — one used in cough suppressants and another used for irregular heartbeats, reports Reuters.

In a 10-week trial of 220 Alzheimer's patients, AVP-923 appeared to reduce agitation more than a placebo. Avanir is also testing its effect on other disorders like Parkinson's, autism and depression.

"A potential new treatment option that could alleviate agitation or aggression as a result of Alzheimer's disease would have a significant impact on the daily life of these patients and of their caregivers," said Constantine Lyketsos, MD, director of the Johns Hopkins Memory and Alzheimer's Treatment Center and study contributor.

Common side effects of AVP-923 include diarrhea, falling and urinary tract infections. Less than 10 percent of patients in the recent trial had these effects, Avanir reports.

AVP-923 has known heart risks. The recent trial did not include patients with a history of certain heart problems.

AVP-923 is still being studied and is not approved by the FDA.

Review Date: 
September 15, 2014
Last Updated:
September 17, 2014