Avanir Pharmaceuticals Announces Initiation of Phase III Trial of AVP-786 for Agitation in Patients with Alzheimer’s Disease
--AVP-786 Granted FDA Fast Track Designation for This Indication –
--Avanir has also initiated a Phase II Trial with AVP-786 for Treatment of Symptoms Associated with Residual Schizophrenia --
ALISO VIEJO, Calif., November 16, 2015‑Avanir Pharmaceuticals, Inc. today announced initiation of enrollment into a phase III clinical trial evaluating AVP-786 for the treatment of agitation in patients with Alzheimer’s disease. This is the first of two placebo-controlled phase III trials in the company’s TRIAD™ program. Avanir Pharmaceuticals recently received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of AVP-786 for this indication.
“Agitation is a common and distressing symptom of Alzheimer’s disease that is associated with accelerated progression of dementia and is a primary cause of institutionalization in the United States,” said Joao Siffert, M.D., executive vice president, R&D, and chief medical officer at Avanir. “The TRIAD program is designed to support the company’s global registration strategy for AVP-786 for the treatment of agitation in patients with Alzheimer’s disease and we are excited to have initiated TRIAD-1 given the large unmet need in this condition.”
The phase III studies (TRIAD-1 and TRIAD-2) are multicenter, randomized, double-blind, placebo-controlled trials that will evaluate two doses of AVP-786 versus placebo over a period of 12-weeks. Endpoints in these studies will include the Cohen Mansfield Agitation Inventory (CMAI), the agitation/aggression domain of the Neuropsychiatry Inventory (NPI), other domains of the NPI, measures of global clinical change, and measures of caregiver burden and quality of life. Standard safety measurements will also be performed. TRIAD-1 is expected to enroll approximately 380 patients in 60 centers in the United States. TRIAD-2 is expected to enroll approximately 325 patients in 50 centers in the U.S. and will begin later in 2015. In addition to these two U.S. based trials, there will be additional global trials that will be conducted as part of the TRIAD program.
Avanir has also initiated a phase II study to assess the efficacy, safety and tolerability of AVP-786 for the treatment of symptoms associated with residual schizophrenia. This study is expected to enroll approximately 120 patients in the U.S. Additionally, Avanir is currently enrolling patients in a phase II study of AVP-786 for the adjunctive treatment of major depressive disorder. This study began in 2014 and is expected to complete enrollment in 2015.
“Avanir is harnessing the unique pharmacology of AVP-786 to further develop multiple potential breakthrough CNS therapies,” continued Dr. Siffert. “The broad development program underway reflects our belief in the potential of AVP-786 to help patients across a wide range of neurologic and psychiatric indications, and our commitment to bringing innovative medicines to patients with CNS disorders of high unmet medical need.”
About Agitation in Alzheimer's Disease
An estimated 5.4 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. 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. There are currently no approved treatments for agitation in patients with Alzheimer’s disease.
AVP-786 is a novel, next-generation investigational drug product consisting of a combination of deuterated (d6)-dextromethorphan (an uncompetitive NMDA receptor antagonist, sigma-1 receptor agonist and inhibitor of the serotonin (SERT) and norepinephrine (NET) transporters), and an ultra-low dose of quinidine. Incorporation of deuterium into the dextromethorphan molecule has been shown to reduce first-pass liver metabolism. By having a lower rate of metabolism, deuterated (d6)-dextromethorphan requires an ultra-low dose of quinidine (an inhibitor of the enzyme CYP 2D6) in the AVP-786 formulation. This may result in a reduced potential for drug interactions and cardiac effects. AVP-786 is an investigational drug not approved by the FDA.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. 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 Pharmaceutical is a leading firm in the challenging area of mental health and also has products and research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical and its affiliates employ approximately 30,000 people globally, and the company welcomes you to visit its global website at: http://www.otsuka.co.jp/en/index.php
Avanir® and TRIAD™ are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries.
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