For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg demonstrated efficacy across multiple measures1,2

Study design

KODIAC 4 and KODIAC 5: Key clinical trials for MOVENTIG1

MOVENTIG 25 mg was evaluated in two multicenter, randomized, double-blind, placebo-controlled trials of 12 weeks’ duration in patients with non-cancer pain and opioid-induced constipation (OIC)1,3

  • OIC was defined as an average of <3 spontaneous bowel movements (SBMs)* per week with accompanying constipation symptoms1
  • Patients were taking a minimum of 30 morphine-equivalent units of opioids per day for at least 4 weeks before enrollment1

At least 50% of patients randomized to each treatment arm qualified as a laxative inadequate responder (LIR) at baseline, according to study protocols1

  • In the 2 weeks prior to the first study visit, patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of 4 days
MOVENTIG (naloxegol) efficacy study patient population.
MOVENTIG (naloxegol) efficacy study patient population.

MOVENTIG 25 mg met the primary endpoint of response in the overall patient population†1

*SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.1

Response in the LIR subgroup was a key secondary endpoint.1

Response over 12 weeks1

For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg provides efficacious and sustained relief from opioid-induced constipation (OIC)1

MOVENTIG (naloxegol) Response in LIR Patients
  • KODIAC 4: LIR patients taking MOVENTIG 25 mg were 69% more likely to respond than patients taking placebo—48.7% vs 28.8% respectively, P=0.0021
  • KODIAC 5: LIR patients taking MOVENTIG 25 mg were 49% more likely to respond—46.8% vs 31.4% respectively, P=0.0141

There were no clinically relevant differences between MOVENTIG and placebo in average pain intensity, daily opioid dose, or opioid withdrawal scores1

*Key secondary endpoint.1

Time to first spontaneous bowel movement (SBM)1

For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg works quickly for most patients—often within a day of first dose1,5

Among LIR patients, median time to first SBM (rescue-free) was approximately 1 day faster than placebo1

MOVENTIG (naloxegol) Median time to first post-dose SBM

MOVENTIG (naloxegol) Median time to first post-dose SBM

  • KODIAC 4: LIR patients taking MOVENTIG 25 mg had a median time to first post-dose SBM of 5.4 hours compared to 43.4 hours for placebo, P<0.001†1
  • KODIAC 5: LIR patients taking MOVENTIG 25 mg had a median time to first post-dose SBM of 18.1 hours compared to 38.2 hours for placebo, P=0.002†1

67% of LIR patients taking MOVENTIG 25 mg achieved an SBM within a day of first dose vs 36% for placebo5

  • KODIAC 4: 75% of LIR patients taking MOVENTIG 25 mg vs 36% of those receiving placebo
  • KODIAC 5: 60% of LIR patients taking MOVENTIG 25 mg vs 36% of those receiving placebo

*This analysis was performed post hoc.

This P value is based on the hazard ratio for MOVENTIG 25 mg vs placebo obtained via stratified log-rank test. The P value is nominal and not adjusted for multiplicity, therefore statistical significance cannot be claimed.

Mean number of SBMs per week2

For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg helps patients progress toward their normal bowel routine1

LIR patients taking MOVENTIG 25 mg experienced an increase in the number of SBMs per week2

MOVENTIG (naloxegol) Mean number of SBMs per week
MOVENTIG (naloxegol) Mean number of SBMs per week
  • KODIAC 4: LIR patients taking MOVENTIG 25 mg experienced an increase in the mean number of SBMs per week from 1.2 to 4.7, while placebo-treated patients experienced an increase from 1.3 to 3.42
  • KODIAC 5: LIR patients taking MOVENTIG 25 mg experienced an increase in the mean number of SBMs per week from 1.2 to 4.8, while placebo-treated patients experienced an increase from 1.4 to 3.52

OIC symptom improvement1

For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg improved key symptoms of opioid-induced constipation (OIC)*1

MOVENTIG (naloxegol) improved symptoms of opioid-induced constipation (OIC)
MOVENTIG (naloxegol) improved symptoms of opioid-induced constipation (OIC)

MOVENTIG (naloxegol) improved symptoms of opioid-induced constipation (OIC)

Stool consistency1,6

  • Stool consistency, as measured by the Bristol Stool Scale, improved with MOVENTIG 25 mg vs placebo in KODIAC 5 but not in KODIAC 4 (change from baseline: 0.9 (n=121) vs 0.4 (n=120), P<0.001, and 0.8 (n=117) vs 0.5 (n=118), P=0.156, respectively)

*Improvement in OIC symptoms was measured by rectal straining, stool consistency, and days with a CSBM in the 12-week studies.1

Severity of straining was measured on the following scale: 1, not at all; 2, a little bit; 3, a moderate amount; 4, a great deal; 5, an extreme amount.

These P values are nominal and not adjusted for multiplicity, therefore statistical significance cannot be claimed.

Patient assessment of constipation symptoms (PAC-SYM) questionnaire1

For adult patients with an inadequate response to laxative(s)

Once-daily MOVENTIG 25 mg improved patient-reported symptom severity scores1

MOVENTIG (naloxegol) improvement in PAC-SYM total scores

MOVENTIG (naloxegol) improvement in PAC-SYM total scores

  • KODIAC 4: LIR patients taking MOVENTIG 25 mg experienced a 0.81-point improvement in PAC-SYM score vs 0.58 for placebo, P=0.023†1,7
    • In all treatment groups, including placebo, improvements in PAC-SYM domains observed in KODIAC 4 were maintained for patients continuing in KODIAC 7, a 12-week extension study‡1
  • KODIAC 5: LIR patients taking MOVENTIG 25 mg experienced a 0.86-point improvement in PAC-SYM score vs 0.56 for placebo, P=0.002†1,7

*The Patient Assessment of Constipation-Symptoms (PAC-SYM) was designed to evaluate the severity of constipation symptoms in three domains (stool, rectal, and abdominal).8

This analysis was performed post hoc; P values are nominal and not adjusted for multiplicity, therefore statistical significance cannot be claimed.

KODIAC 7 was a 12-week safety extension that allowed patients from KODIAC 4 to continue the same blinded treatment from KODIAC 4 for an additional 12 weeks.1