Otsuka : Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia (79KB)
September 27, 2019 at 03:43 am EDT
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For Immediate Release
September 27, 2019
Company name
Otsuka Holdings Co., Ltd.
Representative
Tatsuo Higuchi
President and Representative Director, CEO
Code number
4578 First Section , Tokyo Stock Exchange
Inquiries
Yuji Kogure
Director, Investors Relations Department
Otsuka's Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia
Otsuka Pharmaceutical Co., Ltd. announces that its U.S.-based, indirect subsidiary Avanir Pharmaceuticals, Inc. reports results from the second study of its phase 3 clinical development program investigating the efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of moderate-to-severe agitation in patients with Alzheimer's dementia.
The trial did not meet its primary endpoint and key secondary endpoints. Patients treated with AVP-786 did not experience a statistically significant improvement in agitation compared to patients treated with placebo, as measured by the Cohen- Mansfield Agitation Inventory (CMAI, a 29-item scale to measure agitation), the trial's primary endpoint.
This was a 12-week, multicenter, randomized, double-blind, and placebo-controlled study.
The most common adverse events in patients receiving AVP-786 versus those receiving placebo were falls, urinary tract infection, and somnolence (greater than 5% incidence). No deaths were considered related to treatment.
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Otsuka Holdings Co. Ltd. published this content on 27 September 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 September 2019 07:42:09 UTC
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Otsuka : Subsidiary Avanir Pharmaceuticals Reports Top-line Data from Second Phase 3 Trial Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer's Dementia (79KB)
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