ALISO VIEJO, Calif., June 7, 2017 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. announced today that the company has begun enrollment in a multicenter, randomized, double-blind, placebo-controlled Phase II study of AVP-786 for the treatment of neurobehavioral disinhibition, including aggression, agitation and irritability in patients with traumatic brain injury (TBI). Approximately 150 patients with non-penetrating TBI will be treated for up to 12 weeks at approximately 25 centers in the U.S. to evaluate the efficacy, safety and tolerability of AVP-786.
"Dysfunctional behaviors – such as aggression, agitation and irritability – are estimated to occur in more than half of adults with TBI. These behaviors are amongst the most debilitating consequence of TBI and dramatically impact family, inter-personal and work relationships," said Richard Malamut, MD, chief medical officer, Avanir Pharmaceuticals. "Initiating this Phase II study is an important milestone in evaluating AVP-786 as a treatment to help alleviate these disruptive symptoms."
This new study confirms Avanir's intention to continue investing in the development of AVP-786. Avanir is also studying AVP-786 in clinical trials for residual schizophrenia and agitation associated with Alzheimer's disease.
"Our focus at Avanir is on the symptoms of nervous system diseases that often have no other treatment options and that create significant additional burden for patients, families and caregivers," added Dr. Malamut.
AVP-786 is a novel, next-generation investigational drug product consisting of a combination of deudextromethorphan (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, deudextromethorphan 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 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.
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SOURCE Avanir Pharmaceuticals, Inc.