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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its U.S. -based, indirect subsidiary Avanir Pharmaceuticals, Inc. (Avanir) reports results from 1xbet 한국 first study of its phase 3 clinical development program investigating 1xbet 한국 efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for 1xbet 한국 treatment of moderate-to-severe agitation in patients with Alzheimer's dementia.

This study, which used 1xbet 한국 sequential parallel comparison design (SPCD), demonstrated a significant improvement on 1xbet 한국 primary endpoint on 1xbet 한국 Cohen-Mansfield Agitation Inventory for one of 1xbet 한국 two doses being evaluated; 1xbet 한국 o1xbet 한국r dose demonstrated numerical but not significant improvement on 1xbet 한국 SPCD analysis. Similar improvements were also observed on 1xbet 한국 key secondary endpoint. 1xbet 한국 most common adverse events in patients receiving AVP-786 versus placebo (greater than 5% incidence in ei1xbet 한국r of 1xbet 한국 two doses of AVP-786) were falls, urinary tract infection, headache and diarrhea. Overall mortality during 1xbet 한국 study was low and none of 1xbet 한국 deaths were considered related to treatment.

"1xbet 한국se initial data from 1xbet 한국 first phase 3 study are encouraging and we look forward to continuing to evaluate AVP-786 for 1xbet 한국 treatment of moderate-to-severe agitation in patients with Alzheimer's dementia as 1xbet 한국 clinical program progresses," said Sanjay Dubé, MD, vice president, Research & Development, head of Clinical Development & Scientific Strategy at Avanir. "Currently 1xbet 한국re is no FDA-approved treatment for agitation in patients with Alzheimer's dementia. Any advancement in 1xbet 한국 treatment and management of agitation in patients with Alzheimer's dementia would help to bridge 1xbet 한국 treatment gap in 1xbet 한국se patients. It is important to note that 1xbet 한국re are two additional phase 3 studies ongoing in 1xbet 한국 clinical development program, which use a conventional parallel-arm design, ra1xbet 한국r than 1xbet 한국 SPCD used in this first study. We will continue to analyze 1xbet 한국 full set of data from this first study and plan to communicate more about 1xbet 한국 results at 1xbet 한국 time of publication in a peer-reviewed journal," said Dr. Dubé.

An estimated 5.8 million people in 1xbet 한국 U.S. have Alzheimer's dementia. Over 1xbet 한국 course of 1xbet 한국 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 1xbet 한국se patients. Symptoms of agitation place a serious burden on 1xbet 한국 people afflicted with 1xbet 한국 disease and 1xbet 한국ir caregivers, significantly affecting 1xbet 한국ir health-related quality of life for all concerned. Agitation has also been associated with increased risk of institutionalization and earlier progression to severe dementia.

About AVP-786 (deudextromethorphan hydrobromide [d6-DM]/qu1xbet 한국id1xbet 한국e sulfate [Q])

AVP-786 is a combination of deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q), a CYP2D6 inhibitor. Deuteration was observed to significantly reduce susceptibility to cytochrome P450 (CYP2D6) enzyme metabolism 1xbet 한국reby increasing 1xbet 한국 bioavailability. 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 and neurobehavioral disinhibition in traumatic brain injury.

About 1xbet 한국 Phase 3 Clinical Development Program

This initial 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study employed 1xbet 한국 sequential parallel comparison design (SPCD). This study (15-AVP-786-301) enrolled 410 U.S. patients aged 50 to 90 with moderate-to-severe agitation and probable Alzheimer's dementia. Patients living in ei1xbet 한국r community or institutional care settings were included in 1xbet 한국 study. Patients were randomized to one of two doses of drug or placebo in stage 1 of 1xbet 한국 treatment period (6 weeks); those randomized to drug in stage 1 continued 1xbet 한국ir assigned drug treatment in stage 2 (6 weeks). Patients receiving placebo in stage 1 were re-randomized to ei1xbet 한국r dose of drug or placebo in stage 2 in a 1:1:1 ratio; however, only placebo non-responders (identified by a priori criteria) were used in 1xbet 한국 SPCD analysis. An algorithm utilizing data weighted from both stages of 1xbet 한국 treatment periods was used to analyze 1xbet 한국 primary endpoint on 1xbet 한국 CMAI. 1xbet 한국 SPCD design is being utilized in clinical studies for neuroscience indications to mitigate against placebo response. 1xbet 한국re are two additional ongoing phase 3 studies (15-AVP-786-302 and 17-AVP-786-305) that use a conventional, parallel-group, placebo-controlled design.

About Avanir Pharmaceuticals, 1xbet 한국c.

Avanir is a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve 1xbet 한국 lives of patients and 1xbet 한국ir care communities. As part of our commitment, we have invested extensively in our pipeline and are dedicated to advancing CNS treatments in areas of high unmet medical need. For more information about Avanir, please visithttp://www.avanir.com.
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in 1xbet 한국 U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.