Avanir Pharmaceuticals Announces Positive Phase II Trial Results for AVP-923 in Treatment of Agitation in Patients with Alzheimer's Disease
In addition, improvements were also seen in a majority of the secondary endpoints including the NPI total score (p=0.014), clinical global impression of change-agitation (p=0.0003), patient global impression of change (p=0.001) and measures of caregiver burden (p≤0.05).
"This is an exciting advancement in Alzheimer's disease research," said
"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," added
Data from this phase II study will be presented at the
Based on these results Avanir plans to request a meeting with both the
AVP-923 was found to be generally well-tolerated in this phase II study. The most common adverse reactions were falls, diarrhea, and urinary tract infection occurring in less than 10 percent of patients. There was a low patient discontinuation rate and there were no serious adverse events that were deemed treatment related by the investigators. AVP-923 is known to have certain risks (see 'About AVP-923' section below).
About the Study Design
The objectives of this phase II study were to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of agitation in Alzheimer's patients. The trial was a 10-week, multicenter, randomized, double-blind, placebo-controlled study utilizing a SPCD design intended to reduce placebo response rates. Enrollment was completed with 220 Alzheimer's patients in
About Agitation in Alzheimer's Disease
An estimated six million Americans have Alzheimer's disease, a number that has doubled since 1980 and is expected to be as high as 16 million by 2050. Alzheimer's disease is generally characterized by cognitive decline, impaired performance of daily activities, and behavioral disturbances. Behavioral and psychiatric symptoms develop in as many as 60% of community-dwelling dementia patients and in more than 80% of patients with dementia living in nursing homes; as the disease progresses the risk of such complications approaches 100%. Dementia-related behavioral symptoms, including agitation, can be extremely distressing to the individual, the family, and caregivers. These behavioral disturbances have been associated with more rapid cognitive decline, institutionalization, and increased caregiver burden.
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin transporter (SERT) and norepinephrine (NET) transporter) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which serves to increase the bioavailability of dextromethorphan. AVP-923 is an investigational drug not approved by the
AVANIR® is a trademark or registered trademark of
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with delays in the release of study results, whether preclinical and clinical results for AVP-923 or other dextromethorphan drug products will be predictive of future clinical study results, whether regulatory agencies domestically and internationally will discuss advancement of one or more programs into pivotal studies, whether study data will be accepted for presentation and/or publication and whether a drug candidate can ultimately be successfully developed for commercialization, whether future clinical trials will be completed on time or at all, potential changes in cost, formulation, scope and duration of the clinical studies, obtaining additional indications for commercially marketed products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, whether new drugs can be successfully commercialized, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the
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