Otsuka Pharmaceutical Co., Ltd.

August 18, 2021

Otsuka Obtains Approval in Japan for Orally-Disintegrating-Dose Form of REXULTI® Tablets

Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for an orally-disintegrating-dose (OD) form of REXULTI® (brexpiprazole) tablets.

REXULTI® OD 0.5 mg, 1 mg, and 2 mg tablets will now become available in addition to the already available regular tablets in 1mg and 2mg doses. REXULTI® OD Tablets are a dose form that quickly disintegrate in the oral cavity so that it is easy to take for patients who cannot take the tablet due to difficulty in swallowing.

Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

It received manufacturing and marketing approval in Japan for the indication of schizophrenia in 2018.