Product Dossier
MOVANTIK
Product Dossier for MOVANTIK (naloxegol, Accelagen). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Accelagen
- Active ingredient: naloxegol
- Therapeutic area: Gastroenterology
- Same area: SALOFALK
- Same area: COLOFAC
What it is
Movantik is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). It works as a peripherally acting µ-opioid receptor antagonist.
Approved indications
— Opioid-induced constipation in adult patients who have had an inadequate response to laxative(s).
Dosing overview
Movantik 25 mg once daily was effective in increasing spontaneous bowel movements in adult patients with opioid-induced constipation who had an inadequate response to laxatives.
Key safety warnings
The safety profile was generally acceptable, with common adverse events consistent with its mechanism of action as a peripherally acting µ-opioid receptor antagonist.
Regulatory history
Movantik received TGA approval on 2016-01-05. The 12.5 mg and 25 mg film-coated tablet formulations were first listed on the ARTG on 2016-01-07. The TGA's decision was based on demonstrated efficacy in increasing bowel movements and an acceptable safety profile.