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Phase 3 study of ALKS 3831 for schizophrenia yields positive results
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Alkermes announced positive topline results from a phase 3 study of ALKS 3831, an investigational treatment for schizophrenia that is composed of olanzapine and samidorphan, that showed lower mean percent weight gain compared with olanzapine alone, according to a press release.
Researchers conducted the double-blind, randomized ENLIGHTEN-2 study, the second of two key phase 3 studies in the ALKS 3831 program, to examine the weight gain profile of ALKS 3831 compared with olanzapine alone over 6 months in 561 patients with schizophrenia.
The results showed that ALKS 3831 met its coprimary endpoints, showing both a lower mean percent weight gain from baseline at 6 months compared with olanzapine (P = .003) and a lower number of patients who gained 10% or more of their baseline body weight at 6 months compared with olanzapine (P = .003), according to the release.
The study also met its key secondary endpoint, with the ALKS 3831 treatment group exhibiting a lower number of patients who gained 7% or more of their baseline body weight at 6 months compared with those receiving olanzapine (P = .001). Overall, 64.2% of patients receiving ALKS 3831 and 63.8% of those receiving olanzapine completed the study. During the treatment period, serious adverse events occurred in 3.6% of patients in the ALKS 3831 group and 2.5% of those in the olanzapine group, according to the release.
“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,” Christoph Correll, MD, professor of psychiatry, Hofstra Northwell School of Medicine, said in the release. “People living with schizophrenia deserve treatment options that do not sacrifice tolerability for efficacy. A new therapeutic option with the profile demonstrated by ALKS 3831 in this study would be clinically meaningful for patients and their health care providers.”
Alkermes plans to submit a New Drug Application to the FDA in mid-2019 with the positive results from ENLIGHTEN-2.
Disclosure: Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.