March 2, 2016
Otsuka Pharmaceutical Co., Ltd.
ABILIFY for Extended Release Injectable Suspension, Used to treat Schizophrenia, Has Received Approval in Japan for Administration at Deltoid Muscle Site
- ABILIFY for Extended Release Injectable Suspension (referred to below as ABILIFY long-acting injectable) is a formulation with a 4-week effect in a single administration. Henceforth, it will be possible to administer treatment in an intramuscular area of the upper arm, the deltoid triangular muscle. This becomes an alternative injection site to the conventional intramuscular administration in the buttocks.
- There are estimated to be 710,000 patients with schizophrenia in Japan. Ongoing drug therapy is required in order to prevent the recurrence of symptoms, but patient adherence to oral medications for schizophrenia has been observed to decline from one week following hospital discharge. By the sixth month following discharge over 40% of patients on oral anti-schizophrenia therapies are judged to have poor drug compliance, suggesting that improvements in patient compliance are needed.
- ABILIFY long-acting injectable was developed with the aim of preventing relapse by those patients who are prone when taking oral anti-schizophrenia therapies. The product was launched with the brand name ABILIFY Maintena in the U.S. in March 2013 and subsequently in 27 countries in the E.U., Canada and Australia. It was launched in Japan in May 2015.
Otsuka Pharmaceutical's ABILIFY for Extended Release Injectable Suspension (chemical name is aripiprazole hydrate) in 300 mg and 400 mg vials and in 300 mg and 400 mg pre-filled syringes has received regulatory approval for administration at the deltoid muscle site in the upper arm.
ABILIFY long-acting injectable was introduced in Japan in May 2015 for the treatment of schizophrenia. Until now, the only administration site for the injectable form of the drug has been an intramuscular area of the buttocks.
Information in this news release was current as of the original release date.