Alkermes eyes 2019 filing as schizophrenia drug hits the mark in phase 3

Alkermes' schizophrenia drug met its primary endpoints in a second phase 3 trial, setting it up for an FDA filing in mid-2019. Patients taking the drug gained less weight on average than patients taking olanzapine, the antipsychotic on which it is based. Olanzapine is one of the most commonly prescribed treatments for schizophrenia, but can cause a number of side effects, including metabolic issues and extreme weight gain. Because of this, Eli Lilly, which markets olanzapine as Zyprexa, had to add a warning label indicating these risks in 2007. Alkermes’ candidate, ALKS-3831 combines olanzapine with samidorphan, an opioid antagonist designed to counteract these side effects.
"Significant unmet patient need remains in schizophrenia despite the number of treatment options available. A new agent that offers the robust efficacy of olanzapine but with a favorable weight profile that stabilizes within weeks of treatment initiation would be an important and differentiated addition to the treatment armamentarium for schizophrenia," said Christoph Correll, M.D., a professor of psychiatry and molecular medicine at Hofstra Northwell School of Medicine, in a statement.