Avanir Pharmaceuticals will continue the clinical development program of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with Alzheimer's dementia. The decision is based on insights derived from detailed analysis of data from the first and second phase 3 AVP-786 clinical trials. Preliminary results of the first and second phase 3 clinical trials (15-AVP-786-301 and 15-AVP-786-302) were released March 25 and September 27, 2019, respectively.
The ongoing third phase 3 clinical trial (17-AVP-786-305) will be continued, and additional phase 3 trial activity will be started in 2020.
"Avanir is looking forward to advancing our research. There is a significant unmet medical need for treating agitation in patients with Alzheimer's dementia, as currently there are no FDA-approved treatments," said Sanjay Dubé, MD, Vice President, Research & Development, Head of Clinical Development & Scientific Strategy, Avanir Pharmaceuticals, Inc.
"We took some time to analyze the full set of data from the first two studies of the company's phase 3 clinical development program, and to explore the best path forward. The resulting decision is to continue our ongoing phase 3 clinical trial and start additional phase 3 activity next year," said Wa'el Hashad, President and Chief Executive Officer, Avanir Pharmaceuticals, Inc. "I want to express my deepest gratitude to our Avanir colleagues, and to the patients, caregivers, investigators, and study teams who participate in our clinical programs, and to let them know that we are committed to this important research."
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There will be an estimated 5.8 million people in the United States with Alzheimer's dementia by 2020, and this number is expected to reach 13.8 million by the year 2050. Over the course of the disease, many patients with Alzheimer's dementia will likely experience agitation, which is characterized by excessive motor activity, verbal aggression and physical aggression that causes emotional distress to the patients. Symptoms of agitation place a serious burden on the individuals with Alzheimer's dementia and their caregivers, significantly affecting their health-related quality of life for all concerned. Agitation has also been associated with increased risk of institutionalization and earlier progression to severe dementia.
AVP-786 is a combination of deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q), a CYP2D6 inhibitor. AVP-786 is being studied in a phase 3 clinical development program as a candidate for moderate-to-severe agitation in patients with Alzheimer's dementia. AVP-786 is also being investigated in patients with negative symptoms of schizophrenia, neuro-behavioral disinhibition in traumatic brain injury, and intermittent explosive disorder.