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5 Articles in this Series
Introduction
Coping Skills Key to Pain Management
Insomnia Still Plagues Pain Patients
New Oral Medication Aimed at OIC
Opioid Abuse-Deterrent Technology
Support of Alkaline-Rich Diet

New Oral Medication Aimed at OIC

 

In April, the FDA approved lubiprostone (Amitiza) for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. Lupiprostone, an oral medication, joined methylnatrexone bromide (Relistor) as agents specifically approved for OIC. This is the third indication for Amitiza, which is also approved for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adult women.

The FDA based their approval on phase 3 clinical trials that found lubiprostone improved spontaneous bowel movements (SBM) and opioid-induced constipation (OIC) in patients with chronic non-cancer pain. M. Mazen Jamal, MD and colleagues from the University of California, Irvine, presented the results of one of the randomized controlled studies at PAINWeek. In the study, 431 patients were randomly assigned to receive lubiprostone or placebo. More than one-quarter of libiprostone-treated patients (27.1%) were SBM responders compared with 19% of controls. The median time to first bowel movement was also significantly shorter in the treatment group compared to controls (23.5 h vs 37.7 h). According to the researchers, lubiprostone was also associated with less straining, better stool consistency, and improved constipation severity scores versus controls. The most common adverse events included diarrhea (11.3%), nausea (9.9%), and abdominal pain (7.1%).1

The phase 3 trail was supported by a research grant from Sucampo Pharmaceuticals.

Reference

1. Jamal MM, Mareya S, Joswick T, Ueno R. Lubiprostone significantly improves constipation induced by non-methadone opioids in patients with  chronic, non-cancer pain: results from a phase 3, randomized, double-blind, placebo-controlled clinical trail. Poster presentation at PAINWeek, September 6, 2013, Las Vegas, NV. Poster 3799.

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