WHEN ADDED TO AN ANTIDEPRESSANT IN ADULT
PATIENTS WITH MDD, VRAYLAR DELIVERS:
THE POWER OF BOTH
The power of Both
Proven Efficacy Well-established Tolerability
When added to an antidepressant in adult patients with MDD, VRAYLAR delivers THE POWER OF BOTH:
Proven Efficacy1
In 6- and 8-week trials, VRAYLAR + antidepressant demonstrated
- Reduction in overall depressive symptoms*†
- Relief at lowest dose of 1.5 mg/day*†
- Flexibility to increase to 3 mg/day at day 15*†
Well-Established Tolerability1‡
In 6- and 8-week trials, VRAYLAR + antidepressant demonstrated
- Mean weight change of <2 lb1§
- Metabolic shifts similar to placebo for total cholesterol and fasting triglycerides||
- 97% of patients did not have a clinically meaningful increase in blood glucose¶
*In a 6-week, placebo-controlled trial, mean change from baseline in MADRS total score at 6 weeks: VRAYLAR 1.5 mg/day + ADT (n=250): -14.1 (baseline mean: 32.8, P=0.0050); VRAYLAR 3 mg/day + ADT (n=252): -13.1 (baseline mean: 32.7, P=0.0727); placebo + ADT (n=249): -11.5 (baseline mean: 31.9).1,2
†In an 8-week, placebo-controlled trial, mean change from baseline in MADRS total score at 8 weeks: VRAYLAR 1 -2 mg/day + ADT (n=273): -13.4 (baseline mean: 29.0, P=0.2404); VRAYLAR 2 -4.5 mg/day + ADT (n=271): -14.6 (baseline mean: 29.3, P=0.0114); placebo + ADT (n=264): -12.5 (baseline mean: 28.9).1,2
‡The most common adverse reactions observed in the two 6-week MDD studies (≥5% and at least twice the rate of placebo) were akathisia, nausea, and insomnia. In the 6-week studies, 4% of the patients who received VRAYLAR discontinued treatment due to an adverse reaction, compared with 2% of placebo-treated patients in these trials.1,4
§Weight gain may occur. In two 6-week MDD studies, 2% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day + ADT (n=502) = +1.54 lb; VRAYLAR 3 mg/day + ADT (n=503) = +1.54 lb; placebo + ADT (n=503) = +0.44 lb. In the 8-week MDD study, 2.5% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 2% of those taking placebo. The mean weight changes reported in this study were VRAYLAR 1-2 mg/day + ADT (n=273) = +1.98 lb; VRAYLAR 2 -4.5 mg/day + ADT (n=273) = +1.98 lb; placebo + ADT (n=266) = 0 lbs. Monitor weight at baseline and frequently thereafter.1
||In the 6- and 8-week MDD studies, proportion of patients with metabolic shifts was similar to placebo. Shift defined as: total cholesterol: normal/borderline (<240 mg/dL) to high (≥240 mg/dL); fasting triglycerides: normal/borderline (<200 mg/dL) to high (≥200 mg/dL).1
¶In 6-week studies, the proportion of patients with shifts in fasting glucose from normal (<100 mg/dL) to high (≥126 mg/dL): VRAYLAR 1.5 mg per day + ADT = 2%; VRAYLAR 3 mg per day + ADT = 3.2%; placebo-treated = 1.3%. The proportion of patients with shifts in fasting glucose from normal to borderline (≥100 and <126 mg/dL) or from borderline to high was similar in patients treated with VRAYLAR and placebo. In the 8-week study, the shifts in fasting glucose were similar among the VRAYLAR and placebo + ADT groups.1
ADT=antidepressant therapy; MADRS=Montgomery-Asberg Depression Rating Scale; MDD=major depressive disorder.
VRAYLAR Is APPROVED Across 4 Indications1
Evaluated in 12 clinical trials1#
~6,700 clinical trial patients1
~7 years of real-world experience1
More than 100,000 clinicians have prescribed VRAYLAR2**
#The most common adverse reactions observed in VRAYLAR trials (≥5% and at least twice the rate of placebo): major depressive disorder (two 6-week studies) (VRAYLAR 1.5 mg/day + ADT or 3 mg/day + ADT vs placebo + ADT)—akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%); bipolar I depression (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo)—nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%); bipolar I mania (VRAYLAR 3-6 mg/day vs placebo)—EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%); schizophrenia (VRAYLAR 1.5-3 mg/day and 4.5-6 mg/day vs placebo)—EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%).1
**Inclusive of all indications.
ADT=antidepressant therapy; EPS=extrapyramidal symptoms.
VRAYLAR Savings and Support
VRAYLAR has #1 unrestricted commercial access among branded oral atypical antipsychotics.2*†‡
VRAYLAR Access
- 100% Medicare Part D coverage2
- 94% National Commercial coverage2
*Excluding branded products that have available generics.
†Unrestricted access is defined as a product covered on formulary that does not require a prior authorization and/or step therapy.
‡As of July 2023. Applicable to the atypical antipsychotic market basket. Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.