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ALKS 3831 effective for schizophrenia
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ALKS 3831 — a single bilayer tablet of samidorphan co-formulated with olanzapine — appeared safe and effective for acute exacerbation of schizophrenia, according to phase 3 study results.
“The positive results of ENLIGHTEN-1 provide clear evidence of the safety, tolerability and antipsychotic efficacy of ALKS 3831 in a large, randomized registration trial,” Elliot Ehrich, MD, executive vice president of research and development at Alkermes, said in a press release. “The results of this phase 3 study also provide additional evidence of the antipsychotic properties of ALKS 3831 relative to olanzapine, an agent well known to clinicians. We look forward to completing our analysis of this large study and presenting the data at a future medical meeting.”
To evaluate efficacy, safety and tolerability of ALKS 3831 for schizophrenia, researchers conducted ENLIGHTEN-1, a multinational, double-blind, randomized, phase 3 study, among 403 individuals experiencing acute exacerbation of schizophrenia. Researchers randomly assigned study participants to receive ALKS 3831 coformulated with 10 mg or 20 mg of olanzapine, olanzapine alone, or placebo for 4 weeks.
Compared with placebo, participants who received ALKS 3831 exhibited greater reductions in Positive and Negative Syndrome Scale (PANSS) scores from baseline to 4 weeks (P < .001).
Participants who received olanzapine exhibited similar reductions in PANSS scores, compared with placebo (P = .004).
Improvement in Clinical Global Impression-Severity scores was superior among participants who received ALKS 3831 (P = .002), compared with placebo.
The most common adverse events associated with ALKS 3831 and olanzapine were weight gain, somnolence and dry mouth.
“Many physicians recognize the powerful efficacy profile of olanzapine, but are hesitant to prescribe it given the severe weight gain and metabolic side effects commonly associated with its use,” Christoph Correll, MD, of Hofstra Northwell School of Medicine, said in the release. “A new antipsychotic with robust efficacy and a favorable weight and metabolic profile compared to olanzapine would be a welcome addition to the schizophrenia treatment landscape. This study confirms a key element of this profile, with a clear demonstration of efficacy in a large, well-conducted clinical trial.”
ENLIGHTEN-1 is the first of two phase 3 studies in the ENLIGHTEN clinical development program for ALKS 3831.
ENLIGHTEN-2, a 6-month phase 3 study comparing weight gain between olanzapine and ALKS 3831, is ongoing. Data is expected in 2018.