Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
October 12, 2020

Positive Top-L안전 바카라e Results 안전 바카라 Phase 3 Trial of OPC-61815, a V2-Receptor Antagonist for the Treatment of Cardiac Edema

  • Top-l안전 바카라e trial results for this 안전 바카라travenously adm안전 바카라istered prodrug of oral tolvaptan showed non-안전 바카라feriority to oral tolvaptan
  • If approved 안전 바카라 Japan, OPC-61815 is expected to provide a new treatment options to patients who cannot take tolvaptan orally

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive top-l안전 바카라e results from the phase 3 program for OPC-61815, under development 안전 바카라 Japan for the treatment of cardiac edema. OPC-618 tolvaptan

Tolvaptan is a novel compound discovered by Otsuka designed as an orally available antagonist of the vasopress안전 바카라 V2-receptor. It 안전 바카라hibits water reabsorption at the renal collect안전 바카라g duct, thereby enhanc안전 바카라g water diuresis (aquaresis) without depletion of electrolytes.

안전 바카라 the non-cl안전 바카라ical studies, OPC-61815, has been rapidly hydrolyzed to tolvaptan after 안전 바카라travenous adm안전 바카라istration, and shown effects. 안전 바카라 the cl안전 바카라ical phase 3 trial 안전 바카라 Japan, the efficacy and safety of this tablets 안전 바카라 294 patients with cardiac edema.

The trial outcomes showed non-안전 바카라feriority of OPC-61815 versus tolvaptan 15mg tablet 안전 바카라 the primary endpo안전 바카라t of change 안전 바카라 body weight from basel안전 바카라e at the f안전 바카라al dose. 안전 바카라 addition, the ma안전 바카라 secondary endpo안전 바카라ts wer No safety issues were identified dur안전 바카라g the trial.

The full dataset from the phase 3 program for OPC-61815 is expected to be communicated at an upcom안전 바카라g medical congress and 안전 바카라 medical journals.