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Efficacy

For major depressive disorder in adults

PRISTIQ 50 mg demonstrated relief of emotional and physical symptoms and improvement in functional outcomes2

Efficacy was established in 4 double-blind, randomized, placebo-controlled clinical trials, two of which included the 50 mg dose

PRISTIQ 50 mg: Significant improvement from baseline on the HAM-D17 total score (P<0.001)

Pooled data from 2 double-blind, randomized, placebo-controlled, fixed-dose 8-week trials of 50 mg q.d. and 100 mg q.d. of PRISTIQ in adults aged 18 or older with MDD (N=930). The primary end point was significant reduction in HAM-D17 total score. Data from 50-mg arms is shown. Last-observation-carried-forward (LOCF) analysis shown.2

PRISTIQ 50 mg: Significant improvement on prospectively defined secondary end points at week 8:

  • 60% of patients demonstrated a ≥50% decrease from baseline score on the HAM-D17 (46% placebo; P<0.001)
  • 36% of patients achieved a score of ≤7 on the HAM-D17 scale (24% PBO; P<0.01)2

PRISTIQ 50 mg: Significant improvement on the Sheehan Disability Scale (SDS) (P<0.001)

Pooled data from 2 double-blind, randomized, placebo-controlled, fixed-dose 8-week trials of 50 mg q.d. and 100 mg q.d. of PRISTIQ in adults aged 18 or older with MDD (N=930). The primary end point was significant reduction in HAM-D17 total score. Sheehan Disability Scale (SDS) total score was a measure used to assess health outcomes. Data from 50-mg arms shown. Last-observation-carried-forward (LOCF) analysis shown.2 The SDS measures functional outcomes across the following: work, social life/leisure activities, and family life/home responsibilities.4

PRISTIQ 50 mg demonstrated a significant improvement of 42% (29% placebo, P<0.001) on the SDS, a well-established, validated measure of functional outcomes across the following2,4.

  • Work
  • Social life/leisure activities
  • Family life/home responsibilities
Next: Safety Profile

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