Oral Relistor Opioid-Induced Constipation Drug Heads to FDA
Valeant has submitted a New Drug Application for an oral formulation of methylnaltrexone bromide to treat opioid-induced constipation in adult patients with chronic noncancer pain.
Valeant has submitted a New Drug Application for an oral formulation of methylnaltrexone bromide (Relistor) to treat opioid-induced constipation (OIC) in adult patients with chronic noncancer pain (CNCP).
Relistor is a peripherally acting μ-opioid receptor antagonist designed to relieve OIC without negatively impacting the opioid’s analgesic effect.
Relistor subcutaneous injection was approved by the FDA in 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and then in 2014 to treat OIC in patients with CNCP.
Phase 3 trial results presented at Digestive Disease Week 2012 suggested that Relistor tablets have comparable efficacy with subcutaneous injection in adult patients with OIC and CNCP.
The most common adverse reactions to oral Relistor in these patients were abdominal pain, nausea, flatulence, and diarrhea, though incidence was similar to the placebo groups.