DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies. LYBALVI is approved in the U.S. 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.
In this global, open-label extension study, 523 participants received at least one dose of LYBALVI and 35.9% of participants completed 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 with LYBALVI, as measured by the Clinical Global Impression of Severity (CGI-S) scale (mean change from baseline in CGI-S score of -0.28). Long-term treatment with LYBALVI was associated with minimal changes in body weight (mean change from baseline of +1.47 kg) and waist circumference (observed mean change from baseline of +0.61 cm) with up to four years of treatment. Similarly, there were generally minimal changes in lipid and glycemic parameters, including HDL cholesterol, LDL cholesterol, triglycerides, fasting glucose and HbA1c over the measured time period. Overall, 60% of patients reported an adverse event (AE). The most common AEs reported (>5%) were weight gain, headache, anxiety, insomnia, somnolence, nausea and weight decrease; most AEs were mild to moderate in severity.
“As clinicians, we see firsthand the challenges that people living with complex mental health conditions may face in finding treatment options that work for them long term, in terms of both efficacy and tolerability,” said Jacob S. Ballon, M.D., M.P.H., Clinical Professor of Psychiatry and Behavioral Sciences at Stanford University and a study investigator. “These data, which demonstrated long-term tolerability and symptom control, as well as stability across key weight and metabolic factors, underscore LYBALVI’s established safety and efficacy profile and provide important information for clinicians as we navigate treatment decisions with our patients in the real world.”
“We are pleased to share the topline results from this long-term, open-label study. These data highlight the potential utility of LYBALVI as a foundational maintenance treatment option for people living with schizophrenia or bipolar I disorder and reinforce the safety profile of LYBALVI established in previous studies,” said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. “In this study, patients taking LYBALVI experienced sustained treatment effect and tolerability, including stability across multiple metabolic parameters. Against the backdrop of average treatment persistency of less than six months for oral atypical antipsychotics generally, we are encouraged that more than one-third of subjects completed four years of treatment with LYBALVI.”
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.
Phase 3, Open-Label Study Design
This was a multicenter, phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI for up to four years. Patients were eligible to enroll within seven days of completing one of three antecedent phase 3 clinical trials investigating LYBALVI: the ENLIGHTEN-1 safety extension study; the ENLIGHTEN-2 safety extension study (rollover extensions of the ENLIGHTEN-1 and ENLIGHTEN-2 phase 3 pivotal randomized controlled trials in adults with schizophrenia); and the 12-week ENLIGHTEN-Early randomized controlled trial comparing LYBALVI to olanzapine in young adults with recent-onset schizophrenia, schizophreniform disorder, or bipolar I disorder. In this long-term extension study, patients continued their daily dose of LYBALVI (olanzapine 5-20 mg + samidorphan 10 mg) from their antecedent study for up to an additional four years, with dose adjustments determined by the investigator. A total of 524 patients enrolled in the study, and 523 received ≥1 dose of LYBALVI. Baseline was established based on these 523 patients and changes as compared to baseline were based on those patients who completed four years of open-label treatment with LYBALVI. Patients were mostly male (61.6%) and White (72.7%), with a mean age of 35.1 years. Safety assessments included changes from baseline in body weight and waist circumference and the incidence of adverse events (AEs). Changes in lipid (high-density lipoprotein [HDL], low-density lipoprotein [LDL], and total cholesterol and triglycerides) and glycemic (glucose and glycosylated hemoglobin [HbA1c]) parameters were evaluated. Antipsychotic efficacy was assessed using the Clinical Global Impressions–Severity (CGI-S) scale.
About LYBALVI® (olanzapine and samidorphan)
LYBALVI® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. 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 an adjunct to lithium or valproate. 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 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
About Alkermes plc
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Contacts
Marisa Borgasano
Phone +1 781 609 6659