Otsuka & Lundbeck’s Abilify Maintena Gets FDA Nod for New Formulation

The FDA has signed off on a new formulation of Otsuka and Lundbeck’s collaborative anti-psychotic Abilify Maintena to be delivered via pre-filled dual chamber syringe.

Otsuka and Lundbeck said FDA approved the new Abilify Maintena (aripiprazole) syringe this week, calling it the first of several planned enhancements for the product that was first approved February 2013 and is prescribed for the treatment of schizophrenia.

The new syringe, which allows for a once-a-month injection in either a 300 mg or 400 mg dose, should be available in the U.S. in January, the companies said. 

Abilify Maintena is an atypical antipsychotic based off the tablet version of oral Abilify, which was first approved in 2002. The syringe-version is so far the only injectable dopamine D2 partial agonist approved by the FDA.

The new dual-chamber product proved its efficacy in a placebo-controlled, randomized-withdrawal maintenance trial conducted in patients living with schizophrenia, Otsuka and Lundbeck said.

The companies cautioned that Abilify Maintena is not indicated for patients with dementia-related psychosis and carries increased risk in elderly patients with such a disease. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.