AEs With Movantik, Placebo Compared in Analyses of Elderly Patients

AEs With Movantik, Placebo Compared in Analyses of Elderly Patients
AEs With Movantik, Placebo Compared in Analyses of Elderly Patients

Movantik (naloxegol; AstraZeneca) was found to have a similar incidence of adverse events among elderly patients as compared to placebo or usual care, safety analyses presented at Digestive Disease Week 2015 have shown.

An analysis of the Phase 3 KODIAC-04, KODIAC-05, and KODIAC-08 studies evaluated the effects of Movantik 12.5mg or 25mg daily vs. placebo among patients ≥65 years old with opioid-induced constipation (OIC) and chronic non-cancer pain. Overall safety results in this subset were consistent with those seen in the overall patients populations from Phase 3 studies. The most common adverse reactions with Movantik as compared to placebo in clinical trials were abdominal pain, diarrhea, nausea, flatulence, vomiting, headache, and hyperhidrosis.

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Some specific findings from the sub-analyses in patients aged ≥65 years old include:

  • KODIAC-04 and KODIAC-05 (n=147/1,331): the incidence of adverse events was naloxegol 12.5mg, 50%; naloxegol 25mg, 56.6%; and placebo, 62.0%. The incidence of serious adverse events and discontinuations due to adverse events were comparable among treatment groups in the 12-week pool.
  • KODIAC-08 (n=76/721): the incidence of adverse events was naloxegol 25mg, 86.7%; usual care, 83.9%. The incidence of serious adverse events were 16.1% for usual care vs .15.6% for naloxegol 25mg.

Movantik is an oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.

For more information call (800) 237-8898 or visit Movantik.com.