Novel Schizophrenia Drug Continues to Show Promise

Megan Brooks

April 06, 2015

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.

"ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, in patients with schizophrenia and to have utility in the treatment of schizophrenia in patients with alcohol use," the company explains in a news release.

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.

Positive topline data from this stage, announced in January and reported by Medscape Medical News at that time, showed that ALKS 3831 had antipsychotic efficacy on par with that of olanzapine with favorable effects on weight gain compared with olanzapine.

During the second 3 months, all patients who received ALKS 3831 during the first 3 months continued to receive ALKS 3831, and patients who had received olanzapine were switched to ALKS 3831.

Data from the completed study reported today "support and extend" the initial positive results. ALKS 3831's favorable efficacy and mean weight gain profile "show for the first time that switching patients from olanzapine to ALKS 3831 resulted in a cessation of mean weight gain," the company said today.

ALKS 3831 was generally well tolerated during the 6-month period. The most common adverse events were somnolence, sedation, and dizziness.

"This second 3-month stage of the phase 2 study provided further confirmation of the positive weight effects and strong efficacy of ALKS 3831 for the treatment of schizophrenia over the complete 6-month study and provided exciting new data relating to patients switching from olanzapine," Elliot Ehrich, MD, chief medical officer of Alkermes, said in the release.

The company plans to meet with the US Food and Drug Administration to discuss the phase 2 results, with an eye toward starting the next phase of testing this year.

Schizophrenia affects an estimated 2.4 million Americans.

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