SUZETRIGINE (JOURNAVX®)





Acronyms



DRUGS IN CLASS



FDA-APPROVED INDICATIONS



MECHANISM OF ACTION



PAIN CONTROL

  • Pain was measured on a 0 (no pain) to 10 (worst pain) scale and outcomes are expressed as differences in pain measured over 48 hours, with higher scores indicating more pain relief
  • HC/APAP - hydrocodone 5 mg/APAP 325 mg every 6 hours
Pain relief during the first 48 hours following bunionectomy
Efficacy Measure Suzetrigine
(N=426)
Placebo
(N=216)
HC/APAP
(N=431)
LS mean 99.9 70.6 120.1
LS Mean Difference vs placebo (95% CI)
(p-value)
29.3 (14.0, 44.6)
(p=0.0002)
- -
LS Mean Difference vs HB/APAP (95% CI) -20.2 (-32.7, -7.7) - -
Median time to meaningful pain relief 240 minutes 480 minutes -

  • Pain was measured on a 0 (no pain) to 10 (worst pain) scale and outcomes are expressed as differences in pain measured over 48 hours, with higher scores indicating more pain relief
  • HC/APAP - hydrocodone 5 mg/APAP 325 mg every 6 hours
Pain relief during the first 48 hours following full abdominoplasty
Efficacy Measure Suzetrigine
(N=447)
Placebo
(N=223)
HC/APAP
(N=448)
LS mean 118.4 70.1 111.8
LS Mean Difference vs placebo (95% CI)
(p-value)
48.4 (33.6, 63.1)
(p<0.0001)
- -
LS Mean Difference vs HB/APAP (95% CI) 6.6 (-5.4, 18.7) - -
Median time to meaningful pain relief 119 minutes 480 minutes -


SIDE EFFECTS

  • Side effects reported in ≥1% of suzetrigine-treated patients and greater than rate of placebo
Pooled side effects from bunionectomy and abdominoplasty trials
Side effect Suzetrigine
(N=874)
HC/APAP
(N=879)
Placebo
(N=438)
Pruritus 2.1% 3.4% 1.6%
Muscle spasms 1.3% 0.7% 0.5%
Increased blood creatine phosphokinase 1.1% 0.8% 0.5%
Rash 1.1% 0.7% 0.5%


CONTRAINDICATIONS



PRECAUTIONS




DRUG INTERACTIONS




DOSING






LONG-TERM SAFETY



BIBLIOGRAPHY