Topline results from the complete 6-month phase 2 study of a novel oral antipsychotic show that the drug was as effective as olanzapine (multiple brands) with far less weight gain in patients with schizophrenia, the company developing the drug announced today.
The drug, currently known as ALKS 3831, from Alkermes, combines samidorphan, a novel potent mu-opioid antagonist, with olanzapine.
The 300-patient phase 2 study had two stages. During the initial 3 months, patients were randomly assigned to receive olanzapine or one of three doses of ALKS 3831. Antipsychotic efficacy and weight gain were assessed.
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