Avanir's Drug Combination Reduces Agitation in Alzheimer's Disease Patients
By C. Rajan, contributing writer
Avanir Pharmaceuticals this week announced the positive results from its phase 2 clinical trial for its combination drug therapy AVP-923, which was successful in lowering agitation in patients with Alzheimer's disease.
In the placebo-controlled, randomized, Phase 2 trial for testing safety, tolerability, and efficacy of AVP-923 in 220 Alzheimer's patients, the drug was well tolerated and found to significantly reduce agitation and aggression in the patients, compared to the placebo. Because of these positive results, Avanir plans to meet with the U.S. FDA and the EMA to discuss plans to advance its therapies into pivotal studies for treating agitation in patients with Alzheimer's disease.
"With no FDA approved drugs for the treatment of agitation in Alzheimer's disease, we believe these results represent a breakthrough for patients," said Joao Siffert, MD, CMO at Avanir. "We are extremely excited with the prospect of bringing a potential treatment that can provide clinically meaningful relief to these patients and reduce caregiver burden. These study results represent the second neuropsychiatric disorder where AVP-923 has shown benefit and lends support for further advancement of our research programs into related disorders."
Avanir has designed AVP-923 as a combination of two common drugs — dextromethorphan and quinidine. Dextromethorphan is the active CNS component which is an NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin and norepinephrine transporters. Quinidine is a CYP2D6 enzyme inhibitor which calms irregular heartbeats and increases the bioavailability of dextromethorphan.
The company plans to present the data from this Phase 2 study of AVP-923 at the American Neurological Association's (ANA) 2014 Annual Meeting in Baltimore in October 2014.
Nearly six million people in the U.S. suffer from Alzheimer’s disease, and by 2050, an estimated 16 million Americans will have this neurological condition, according to Avanir. Alzheimer's disease results in cognitive decline, impaired performance of daily activities, and behavioral disturbances. In addition, about 60 to 80 percent of patients will develop behavioral and psychiatric symptoms, including agitation. The dementia-related agitation increases the burden of care, and also leads to more rapid cognitive decline and institutionalization of the patients.
Avanir, a California based biotech firm, is developing therapies for various CNS disorders of high unmet medical need. Last month, the company initiated a Phase 2 clinical trial for major depressive disorder for AVP-786, which is based on the same dextromethorphan/quinidine combination as AVP-923, but with a different composition. The company also recently announced positive results from Phase 3 trials of another drug, AVP-825 (sumatriptan), for treatment of acute migraines.