Alkermes has announced that the candidate was generally well tolerated in the four-year extension study. Image credit: Shutterstock / Doidam 10.

Topline data from a Phase III open-label extension (OLE) study demonstrated that Alkermes’s Lybalvi (olanzapine and samidorphan) was generally well tolerated for up to four years of treatment in patients with schizophrenia, schizophreniform disorder or bipolar I disorder.

The Phase III trial (NCT03201757) evaluated the long-term safety, tolerability and durability of Lybalvi’s treatment effect in patients for up to four years of treatment.

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Lybalvi is approved in the US for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate.

OLE trial results

In the global OLE trial, 523 participants received at least one dose of Lybalvi, with 35.9% of participants completing the four-year treatment period.

The safety profile of Lybalvi was consistent with previous studies. Patients’ symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment, as measured by the Clinical Global Impression of Severity (CGI-S) scale with a mean change from baseline of -0.28.

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Long-term treatment with Lybalvi was associated with minimal changes in body weight with a mean change from baseline of 1.47kg.

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In addition, 60% of patients reported an adverse event (AE) with the most common AEs being weight gain, headache, anxiety, insomnia, somnolence, nausea, and weight decrease. Most AEs were mild to moderate in severity.

Alkermes expects to submit results from this open-label, long-term study to a peer-reviewed journal for publication and to present additional study results at upcoming scientific meetings.

Trial design

Patients were eligible to enrol into the OLE study within seven days of completing one of three Phase III clinical trials investigating Lybalvi: the ENLIGHTEN-1 safety extension study (NCT02634346); the ENLIGHTEN-2 safety extension study (NCT02694328) and the 12-week ENLIGHTEN-Early trial (NCT03187769).

Patients continued their daily dose of Lybalvi from their antecedent study for up to an additional four years, with dose adjustments determined by the investigator.

Lybalvi is a combination of olanzapine, an atypical antipsychotic; and samidorphan, an opioid antagonist, in a single bilayer tablet. Lybalvi is available in fixed dosage strengths composed of 10mg of samidorphan and 5mg, 10mg, 15mg or 20mg of olanzapine. It was approved by the US Food and Drug Administration (FDA) in June 2021.

According to GlobalData’s Pharmaceutical Intelligence Centre, the global sales market forecast for Lybalvi is predicted to be $678m in 2029.

GlobalData is the parent company of the Clinical Trials Arena.

Alkermes has five other marketed drugs, including Aristada (aripiprazole lauroxil) and Aristada Initio, both FDA-approved for schizophrenia.