ZULRESSO. Efficacy for when days count.

Not an actual patient.

Not an actual patient.

Primary endpoint

In 2 pivotal Phase III clinical studies, statistically significant reduction in PPD severity in 2.5* days

LS mean change from baseline in HAM-D total score vs placebo1,2

Study 1 and Study 2 showing superior PPD symptom reduction in 2.5 days

Target dosage:

ZULRESSO 90 mcg/kg/hour

ZULRESSO 60 mcg/kg/hour

PLACEBO

ZULRESSO was studied in two multicenter, randomized, double-blind, placebo-controlled studies in women aged 18 to 45 years with PPD, up to 6 months postpartum, who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode (DSM-IV) with onset of symptoms in the third trimester or within 4 weeks of delivery. Patients received a 60-hour continuous intravenous infusion of ZULRESSO or placebo and were then followed for 4 weeks. Baseline oral antidepressant use was reported for 23% of patients.

  • In Study 1 and Study 2, the primary endpoint was the mean change from baseline in depressive symptoms as measured by the HAM-D total score at the end of the infusion (Hour 60)

  • In both placebo-controlled studies, titration to the recommended target dose of ZULRESSO 90 mcg/kg/hour was statistically significant in improvement of depressive symptoms vs placebo

  • In a group of 38 patients in Study 1, a ZULRESSO titration to a target dose of 60 mcg/kg/hour was superior to placebo in improvement of depressive symptoms

STUDY 11

SEVERE

Recommended target dosage:

90 mcg/kg/hour arm

Baseline: mean HAM-D score of 28.4
  • LS mean change from baseline: -17.7
  • Difference from placebo arm: -3.7 (P=0.0252)
Target dosage:

60 mcg/kg/hour arm

Baseline: mean HAM-D score of 29.0
  • LS mean change from baseline: -19.5
  • Difference from placebo arm: -5.5 (P=0.0013)

Placebo arm

Baseline: mean HAM-D score of 28.6
  • LS mean change from baseline: -14.0

STUDY 21

MODERATE

Recommended target dosage:

90 mcg/kg/hour arm

Baseline: mean HAM-D score of 22.6
  • LS mean change from baseline: -14.6
  • Difference from placebo arm: -2.5 (P=0.0160)

Placebo arm

Baseline: mean HAM-D score of 22.7
  • LS mean change from baseline: -12.1

STUDY 11

SEVERE

Baseline: mean HAM-D score of 28.4
  • LS mean change from baseline: -17.7
  • Difference from placebo arm: -3.7 (P=0.0252)

Baseline: mean HAM-D score of 29.0
  • LS mean change from baseline: -19.5
  • Difference from placebo arm: -5.5 (P=0.0013)

Baseline: mean HAM-D score of 28.6
  • LS mean change from baseline: -14.0

STUDY 21

MODERATE

Baseline: mean HAM-D score of 22.6
  • LS mean change from baseline: -14.6
  • Difference from placebo arm: -2.5 (P=0.0160)

Baseline: mean HAM-D score of 22.7
  • LS mean change from baseline: -12.1
Individual results may vary. HAM-D=Hamilton Depression Rating Scale; LS=least squares.
*2.5 days=Hour 60. Intention to treat population. Statistically significant after multiplicity adjustments.

Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is available only through a restricted program called the ZULRESSO REMS. Patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).1

2.5 days later

ZULRESSO-treated patients experienced rapid improvement of depressive symptoms1

Change from baseline in HAM-D total score over time in Study 1 with the recommended target dosage of ZULRESSO (90 mcg/kg/hour)1,2

ZULRESSO-treated patients experienced rapid improvement of depressive symptoms, reduction in depressive symptoms in 2.5 days ZULRESSO-treated patients experienced rapid improvement of depressive symptoms, reduction in depressive symptoms in 2.5 days

Target dosage:

ZULRESSO 90 mcg/kg/hour (n=41)

PLACEBO (n=43)

A similar therapeutic effect was also observed in the 60 mcg/kg/hour arm.

*2.5 days=Hour 60. Statistically significant after multiplicity adjustments. Intention to treat population.
Individual results may vary. HAM-D=Hamilton Depression Rating Scale; LS=least squares.
  • A prespecified secondary efficacy endpoint was the mean change from baseline in HAM-D total score at Day 30

  • In Study 1, significantly greater symptom reduction vs placebo was observed at Day 30

  • In Study 2, the 90 mcg/kg/hour arm maintained therapeutic effect at Day 30, but did not show a greater reduction vs placebo

Risk of suicidal thoughts and behaviors: ZULRESSO does not directly effect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown.1

Consider changing the therapeutic regimen, including discontinuing ZULRESSO, in patients whose depression becomes worse or who experience emergent suicidal thoughts and behaviors.1