Avanir Pharmaceuticals, Inc. to Continue Clinical Development of Investigational AVP-786 for the Treatment of Agitation in Patients with Alzheimer's Dementia

ALISO VIEJO, Calif., Nov. 12, 2019 /PRNewswire/ -- Avanir Pharmaceuticals, Inc., a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve the lives of patients and their care communities, announced today that it 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."

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 2050ⁱ. Over the course of the disease, many patients with Alzheimer's dementia will likely experience agitationⁱⁱ, which is characterized by excessive motor activity, verbal aggression and physical aggression that causes emotional distress to the patientsⁱⁱⁱ. 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^iv. Agitation has also been associated with increased risk of institutionalization and earlier progression to severe dementia^{v, vi, vii}.

About AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q])
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.

About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve the lives of patients and their care communities. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing CNS treatments in areas of high unmet medical need. For more information about Avanir, please visit http://www.avanir.com.

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd., a global healthcare company with the corporate philosophy, "Otsuka-people creating new products for better health worldwide."

Otsuka researches, develops, manufactures and markets innovative and original pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does. Otsuka Pharmaceutical and its related companies employ approximately 31,000 people worldwide. You can visit the company's global website at https://www.otsuka.co.jp/en.

For additional information, please contact:
Corporate Communications, Avanir Pharmaceuticals, Inc.
T: 949-389-6738
E: [email protected]

ⁱ Hebert L, et al. "Alzheimer disease in the United States (2010-2050), estimated using the 2010 census." Neurology, 80(19): 1778–1783. 2013. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3719424/  
ⁱⁱ Alzheimer's Association. "2017 Alzheimer's Disease Facts and Figures." Alzheimer's & Dementia, 13: 325-373. April 2017. https://www.sciencedirect.com/science/article/pii/S1552526017300511?viewFullText=true
ⁱⁱⁱ Cummings J, et al. "Agitation in cognitive disorders: International Psychogeriatric Association provisional consensus clinical and research definition." International Psychogeriatrics, 27:1, 7–17. 2015. https://www.ncbi.nlm.nih.gov/pubmed/25311499
^iv Laybourne A, et al. "Carer coping and resident agitation as predictors of quality of life in care home residents living with dementia: Managing Agitation and Raising Quality of Life (MARQUE) English national care home prospective cohort study." International Journal Of Geriatric. Psychiatry, 34:106-113. 2018. https://www.ncbi.nlm.nih.gov/pubmed/30276865
^v Knapp M, et al. "Predictors of care home and hospital admissions and their costs for older people with Alzheimer's disease: findings from a large London case register." BMJ Open, 6:11, 1-15. 2016. https://bmjopen.bmj.com/content/bmjopen/6/11/e013591.full.pdf
^vi Rabins P, et al. "Neuropsychiatric symptoms at baseline predict shorter time to severe dementia in a population-based sample of incident Alzheimer's disease: The Cache County dementia progression study." Alzheimer's and Dementia, supplement, 8.4: 126-127. 2012. https://www.alzheimersanddementia.com/article/S1552-5260(12)00465-7/abstract
^vii Peters M, et al. "Neuropsychiatric symptoms as predictors of progression to severe Alzheimer's dementia and death: The Cache County Dementia Progression Study."172(5): 460-5. 2015. https://www.ncbi.nlm.nih.gov/pubmed/25585033.

SOURCE Avanir Pharmaceuticals, Inc.

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