LYBALVI (olanzapine and samidorphan) is the ONLY branded oral atypical antipsychotic with a maintenance indication for bipolar I disorder1-6
LYBALVI is proven to treat manic or mixed episodes of bipolar I in adults1
The efficacy of LYBALVI in the treatment of adult patients with bipolar I disorder has been established based on adequate and well-controlled studies of orally administered olanzapine. The information below describes the results of adequate and well-controlled studies of olanzapine in patients with bipolar I disorder.
In adults with bipolar I disorder with manic or mixed episodes
Olanzapine monotherapy was superior in reduction of mania as measured by the Y-MRS total score1*
In a 3-week trial (N=67) and a 4-week trial (N=115)†
Olanzapine demonstrated superiority vs placebo
†Dose range of olanzapine was 5 mg/day to 20 mg/day, once daily, starting at 10 mg/day in the 3-week study and starting at 15 mg/day in the 4-week study.
Study participants were adults who met DSM-IV criteria for bipolar I disorder with manic or mixed episodes, including patients with or without psychotic features and with or without a rapid-cycling course.
In an identically designed 3-week study
- In an identically designed 3-week study conducted simultaneously with the first study, olanzapine demonstrated a similar treatment difference but, possibly due to sample size and site variability, was not shown to be superior to placebo on this outcome1
Olanzapine, in combination with lithium or valproate, was superior in reduction of mania as measured by the Y-MRS total score1*
Across two 6-week, placebo-controlled combination studies (N=175 and N=169)‡
Olanzapine demonstrated superiority in combination with lithium or valproate vs lithium or valproate with placebo
In outpatients on lithium or valproate therapy:
- With inadequately controlled manic or mixed symptoms (Y-MRS ≥16)
- With or without psychotic symptoms
- With or without rapid cycling course
‡Olanzapine was administered (in a dose range of 5 mg/day to 20 mg/day, once daily, starting at 10 mg/day) combined with lithium or valproate (in a therapeutic range of 0.6 mEq/L to 1.2 mEq/L or 50 µg/mL to 125 µg/mL, respectively).
Study participants were outpatients on lithium or valproate therapy with inadequately controlled manic or mixed symptoms (Y-MRS ≥16).
*The primary outcome in these studies was change from baseline in the Y-MRS total score. The Y-MRS is an 11-item clinician‑rated scale traditionally used to assess the degree of manic symptomatology in a range from 0 (no manic features) to 60 (maximum score).1
Patients taking olanzapine maintenance monotherapy had a significantly longer time to relapse§ vs placebo1
- Patients meeting DSM-IV criteria with manic or mixed episodes who had responded during an initial open-label, 2-week treatment phase to olanzapine 5 mg/day to 20 mg/day were randomized to either continuation of olanzapine at their same dose (n=225) or to placebo (n=136) for observation of relapse1
- In the randomized phase, approximately 50% of the patients had discontinued from the olanzapine group by Day 59, and 50% of the placebo group had discontinued by Day 23 of double-blind treatment1
Patients taking olanzapine stayed on treatment longer vs placebo
Days to discontinuation
§Relapse was defined as an increase of the Y-MRS or HAM-D 21 total score to ≥15, or being hospitalized for either mania or depression.1
Adverse reactions with olanzapine in bipolar I disorder1
The safety of LYBALVI for the treatment of bipolar I disorder (manic or mixed) monotherapy and adjunct to lithium or valproate is based on adequate and well-controlled studies of olanzapine tablets in bipolar I disorder.1
Most common adverse reactions from short-term trials of olanzapine in patients with manic or mixed episodes1
- Incidence of ≥5% of patients exposed to olanzapine and ≥2X the rate of placebo
|As adjunct to lithium or valproate