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BMS and Otsuka get approval for new Abilify formulation

Bristol-Myers Squibb and Otsuka Pharmaceutical have received approval from the FDA for an oral solution formulation of their schizophrenia and bipolar disorder treatment, Abilify.

Abilify (aripiprazole) Oral Solution will provide an important new option for adult patients who are unable to swallow or have difficulty swallowing tablets, providing a greater measure of flexibility in addressing individual patient needs.

Abilify is indicated for the treatment of schizophrenia and acute manic and mixed episodes associated with bipolar disorder. It is the first and only dopamine partial agonist and, since its introduction in 2002, has been prescribed to more than 700,000 patients.

“We are very proud to have discovered Abilify, a unique pharmacological agent that represents our strong focus on pharmaceutical innovation,” said Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical. “It is very encouraging that this medication is now approved in two formulations to allow greater flexibility in supporting the management of patients requiring different options.”

The oral solution formulation will be available in pharmacies in February 2005.