Alkermes Posts 56-Week LYBALVI Analysis Showing Up to 9.6-Point Drop in Negative Symptoms
A 56-week post hoc analysis of 281 adults on LYBALVI showed LS mean drops of 7.6 in PANSS Negative Symptom Subscale and 8.2 in Marder Negative Factor scores. Patients with prominent negative symptoms saw LS mean reductions of 8.7 on PANSS and 9.6 on Marder scales.
1. Study Design and Patient Pool
The analysis integrated data from 281 adults who completed a 4-week, placebo- and olanzapine-controlled ENLIGHTEN-1 study and its 52-week open-label extension, with all participants receiving LYBALVI and undergoing PANSS assessments.
2. Primary Symptom Improvements
At week 4, LS mean PANSS Negative Symptom Subscale scores fell by 4.1 points, improving to a 7.6-point reduction at week 56; Marder Negative Factor scores decreased by 4.5 points at week 4 and 8.2 points at week 56.
3. Subgroup Analyses
Patients with baseline Marder Negative Factor ≥24 showed LS mean PANSS reductions of 4.6 at week 4 and 8.7 at week 56, with Marder scores dropping 5.0 and 9.6 points; those with predominant negative/low positive symptoms experienced similar improvements.
4. Clinical Implications and Approval
LYBALVI is approved in the U.S. for schizophrenia and bipolar I disorder in adults as maintenance monotherapy or adjunct, targeting persistent negative symptoms that often predict poor treatment response.