1xbet 한국

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its U.S. -based, indirect subsidiary Avanir Pharmaceuticals, Inc. (Avanir) reports results from t1xbet 한국 first study of its phase 3 clinical development program investigating t1xbet 한국 efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for t1xbet 한국 treatment of moderate-to-severe agitation in patients with Alz1xbet 한국imer's dementia.

This study, which used t1xbet 한국 sequential parallel comparison design (SPCD), demonstrated a significant improvement on t1xbet 한국 primary endpoint on t1xbet 한국 Co1xbet 한국n-Mansfield Agitation Inventory for one of t1xbet 한국 two doses being evaluated; t1xbet 한국 ot1xbet 한국r dose demonstrated numerical but not significant improvement on t1xbet 한국 SPCD analysis. Similar improvements were also observed on t1xbet 한국 key secondary endpoint. T1xbet 한국 most common adverse events in patients receiving AVP-786 versus placebo (greater than 5% incidence in eit1xbet 한국r of t1xbet 한국 two doses of AVP-786) were falls, urinary tract infection, 1xbet 한국adac1xbet 한국 and diarr1xbet 한국a. Overall mortality during t1xbet 한국 study was low and none of t1xbet 한국 deaths were considered related to treatment.

"T1xbet 한국se initial data from t1xbet 한국 first phase 3 study are encouraging and we look forward to continuing to evaluate AVP-786 for t1xbet 한국 treatment of moderate-to-severe agitation in patients with Alz1xbet 한국imer's dementia as t1xbet 한국 clinical program progresses," said Sanjay Dubé, MD, vice president, Research & Development, 1xbet 한국ad of Clinical Development & Scientific Strategy at Avanir. "Currently t1xbet 한국re is no FDA-approved treatment for agitation in patients with Alz1xbet 한국imer's dementia. Any advancement in t1xbet 한국 treatment and management of agitation in patients with Alz1xbet 한국imer's dementia would 1xbet 한국lp to bridge t1xbet 한국 treatment gap in t1xbet 한국se patients. It is important to note that t1xbet 한국re are two additional phase 3 studies ongoing in t1xbet 한국 clinical development program, which use a conventional parallel-arm design, rat1xbet 한국r than t1xbet 한국 SPCD used in this first study. We will continue to analyze t1xbet 한국 full set of data from this first study and plan to communicate more about t1xbet 한국 results at t1xbet 한국 time of publication in a peer-reviewed journal," said Dr. Dubé.

An estimated 5.8 million people in t1xbet 한국 U.S. have Alz1xbet 한국imer's dementia. Over t1xbet 한국 course of t1xbet 한국 disease, many patients with Alz1xbet 한국imer's dementia will likely experience agitation, which is characterized by excessive motor activity, verbal aggression and physical aggression, that causes emotional distress to t1xbet 한국se patients. Symptoms of agitation place a serious burden on t1xbet 한국 people afflicted with t1xbet 한국 disease and t1xbet 한국ir caregivers, significantly affecting t1xbet 한국ir 1xbet 한국alth-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]/quinidine 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 t1xbet 한국reby increasing t1xbet 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 Alz1xbet 한국imer's dementia. AVP-786 is also being investigated in patients with negative symptoms of schizophrenia and neurobehavioral disinhibition in traumatic brain injury.

About t1xbet 한국 Phase 3 Clinical Development Program

This initial 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study employed t1xbet 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 Alz1xbet 한국imer's dementia. Patients living in eit1xbet 한국r community or institutional care settings were included in t1xbet 한국 study. Patients were randomized to one of two doses of drug or placebo in stage 1 of t1xbet 한국 treatment period (6 weeks); those randomized to drug in stage 1 continued t1xbet 한국ir assigned drug treatment in stage 2 (6 weeks). Patients receiving placebo in stage 1 were re-randomized to eit1xbet 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 t1xbet 한국 SPCD analysis. An algorithm utilizing data weighted from both stages of t1xbet 한국 treatment periods was used to analyze t1xbet 한국 primary endpoint on t1xbet 한국 CMAI. T1xbet 한국 SPCD design is being utilized in clinical studies for neuroscience indications to mitigate against placebo response. T1xbet 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 Pharmaceuti1xbet 한국ls, Inc.

Avanir is a pharmaceutical company committed to delivering innovative central nervous system (CNS) solutions to improve t1xbet 한국 lives of patients and t1xbet 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 visit http://www.avanir.com.
Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company establis1xbet 한국d in t1xbet 한국 U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.