Alkermes publishes 56-week LYBALVI analysis on schizophrenia symptoms

Alkermes plc (NASDAQ: ALKS) announced the publication of a 56-week analysis examining LYBALVI's effects on negative symptoms in adults with schizophrenia. The study was published in The Journal of Clinical Psychiatry.

The analysis examined data from 281 adults who completed the ENLIGHTEN-1 study and subsequently enrolled in a 52-week open-label extension study. LYBALVI demonstrated improvements in negative symptom scores over the treatment period.

In the overall patient population, least squares mean changes from baseline in PANSS Negative Symptoms Subscale scores were -4.1 at week 4 and -7.6 at week 56. For the Marder Negative Factor scores, changes were -4.5 at week 4 and -8.2 at week 56.

Among patients with prominent negative symptoms at baseline (n=186), PANSS Negative Symptoms Subscale scores changed by -4.6 at week 4 and -8.7 at week 56. Marder Negative Factor scores in this subgroup changed by -5.0 at week 4 and -9.6 at week 56.

The analysis was limited by the absence of a control group in the extension study and included only patients who initially experienced acute exacerbation of schizophrenia. The number of patients meeting criteria for predominant negative symptoms was relatively small.

LYBALVI is approved in the U.S. for treating schizophrenia and bipolar I disorder in adults. The medication combines olanzapine, an atypical antipsychotic, with samidorphan, an opioid antagonist, in a single tablet.

Negative symptoms in schizophrenia include reduced emotional expression, decreased speech, and diminished motivation. These symptoms are often associated with reduced functioning and can predict poor treatment response.

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