B-MS to file NDA for Abilitat in 4th quarter

Bristol-Myers Squibb has said it intends to file for US Food and DrugAdministration approval of its experimental schizophrenia drug Abilitat (aripiprazole) in the fourth quarter of 2001 after preliminary data from ongoing Phase III clinical trials supported the drug's efficacy and safety. B-MS has developed Abilitat in collaboration with Otsuka Pharmaceuticals of Japan (Marketletter May 22, 2000).

Aripiprazole acts as an agonist at presynaptic dopamine D2 receptors and an antagonist at postsynaptic D2 receptors but, unlike older agents such as haloperidol, does not upregulate these receptors, a process thought to contribute to extrapyramidal side effects. The company noted in its first-quarter results conference call that aripiprazole's profile, particularly with regard to tolerability (eg a low rate of EPS and little tendency to elevate prolactin levels) should allow it to make headway in the increasingly crowded market for schizophrenia treatment. Other Phase III trials are comparing aripiprazole with other atypical antipsychotics, which include Eli Lilly's market-leading Zyprexa (olanzapine) and Janssen's Risperdal (risperidone).