Ireland's Alkermes ($ALKS) has hit a key milestone in its quest to develop a long-acting version of Abilify for schizophrenia. The biotech, which has R&D operations in Waltham, MA, says it has completed enrollment in the pivotal Phase III study, putting the research team on track to report top-line data in the first half of next year.
"There is a clear and compelling need for long-acting injectable medicines for patients with schizophrenia," said
Researchers will gather 12-week data on the change from baseline in the Positive and Negative Syndrome Scale (PANSS) score, a standard outcome measure in the evaluation of schizophrenia treatment.
Alkermes already has a pair of schizophrenia drugs on the market through its marketing deal with J&J. And the biotech has also been prepping a midstage study of an antipsychotic--ALKS 3831--a broad-spectrum therapy combining a new opioid modulator, ALKS 33, and Zyprexa, shooting for a new-and-improved approach to schizophrenia without the threat of sudden weight gain.
Alkermes has been building a solid rep as an experienced developer looking to reformulate and improve on existing therapies.
- here's the press release