Otsuka launches once-every-2-months inj 'Abilify Asimtufii'

Maintains stable blood drug concentrations of aripiprazole with administration once every 2 months

Has proven safety and efficacy comparable to that of the existing drug Abilify Maintena

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Otsuka Pharmaceutical Korea announced on August 1 that it will launch 'Abilify Asimtufii Inj (aripiprazole monohydrate),' starting in August, as the reimbursement coverage by the National Health Insurance has been applied.

 

'Abilify Asimtufii Inj' is an extended-release formulation administered once every two months.

 

It was approved on February 26 by the Ministry of Food and Drug Safety as a monotherapy for the treatment of schizophrenia and bipolar I disorder.

 

A single administration can sustain a stable blood drug concentration for two months, thus it is expected to contribute to reducing the burden of medication and increasing treatment convenience in patients with psychiatric diseases.

 

Abilify Asimtufii Inj is being launched as two dosages: 960 mg and 720 mg.

 

The convenience of administration has been improved.

 

For Abilify Maintena Inj, preparation before administration requires vigorous shaking for about 20 seconds after reconstitution.

 

However, Abilify Asimtufii has been simplified, requiring only 10 gentle taps followed by shaking for 10 seconds, eliminating the need for a reconstitution process.

 

Furthermore, similar to the existing 1-month prolonged-release injectable Abilify Maintena, patients stably taking oral aripiprazole can initiate treatment, or patients currently on Abilify Maintena can switch to Abilify Asimtufii on their next scheduled dose.

 

A healthcare professional must administer it into the gluteal muscle.

 

This formulation is an atypical antipsychotic drug that acts as a dopamine-serotonin system psychotropic agent.

 

The efficacy of the drug was demonstrated in the treatment of schizophrenia and bipolar I disorder through partial agonism at dopamine D2 receptors and serotonin 5-HT1A receptors, and antagonism at serotonin 5-HT2A receptors.

 

Sung-ho Moon, CEO of Korea Otsuka Pharmaceutical, said, "In the treatment of schizophrenia and bipolar I disorder, medication adherence is a crucial factor for patients' long-term prognosis, relapse prevention, recovery of social function, and improvement in quality of life," and added, "In Korea, medication adherence for psychiatric treatments is lower compared to other developed countries.

 

Therefore, long-acting injectables will play an important role not only in therapeutic efficacy but also in improving adherence." Moon further added, "With Abilify Asimtufii, Otsuka Pharmaceutical Korea will actively support patients with schizophrenia and bipolar disorder in Korea to overcome their illnesses and improve their quality of life." Meanwhile, Abilify Asimtufii is currently used in over 26 countries, including the United States, Canada, the United Kingdom, and the EU.