New Drug Shows Promise in Treating Diarrhea-Associated Irritable Bowel Syndrome
Michael R. Page, PharmD, RPh
Published Online: Wednesday, February 19, 2014
Furiex Pharmaceuticals, Inc, has completed phase-3 trials of eluxadoline, which may help improve quality of life for those with diarrhea-associated irritable bowel syndrome.
Furiex Pharmaceuticals, Inc, has announced results of a large, phase-3 clinical trial of a new drug to treat symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D) and abdominal pain associated with the condition. The drug, eluxadoline, is likely to receive approval in the European Union by early 2015, and approval is also being sought in the United States.
In the phase-3 trials, 2428 patients received eluxadoline. Over 26 weeks, the medication reduced abdominal pain scores and improved stool consistency, both at 100 mg and 75 mg daily dosages.1 Although the full results of the phase-3 study are not yet available,2,3 in November 2013, Furiex published results of an earlier study evaluating the effect of eluxadoline on health-related quality of life in 754 patients with IBS-D.4
Patients enrolled in the latter trial were between 18 and 65 years of age, and almost 70% of participants were female. Assessments of participants’ quality of life using the 34-item Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire were completed 2 weeks before and 12 weeks after the start of treatment. Baseline IBS-QOL total scores averaged 53.2 points on a 100-point scale. Based on previous research, investigators defined a 14-point improvement in symptoms on the IBS-QOL scale as the minimally clinically relevant improvement.4
A clinically relevant improvement in IBS-QOL scores occurred in 48% of placebo-treated patients and a greater portion (more than 65%) of patients receiving eluxadoline at a dosage of 100 mg daily (number needed to treat [NNT] ≈ 6). A much greater, 22-point, improvement occurred in 25% of patients receiving placebo compared with more than 47% of patients receiving 100-mg eluxadoline daily (NNT ≈ 5).4
Eluxadoline acts as a mu opioid–receptor agonist and delta opioid–receptor antagonist. According to Furiex, the most common adverse events observed with the medication’s use include nausea, vomiting, and abdominal pain. However, these adverse events occurred in a similar portion of patients receiving placebo.5 Fred Eshelman, founder and chairmen of Furiex, has predicted that if eluxadoline is approved, it will generate annual sales totaling $750 million to $1 billion.1
1. Furiex irritable bowel syndrome drug succeeds in large trials. Reuters website. www.reuters.com/article/2014/02/04/furiex-bowel-idINL2N0L81RK20140204. Accessed February 2014.
2. Efficacy, safety, and tolerability of JNJ-27018966 in the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-d) (protocol JNJ-27018966IBS3001). http://clinicaltrials.gov/ct2/show/NCT01553591. Accessed February 2014.
3. Efficacy, safety, and tolerability of JNJ-27018966 in the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-d) (protocol JNJ-27018966IBS3002). http://clinicaltrials.gov/ct2/show/NCT01553747. Accessed February 2014.
4. Andrae DA, Patrick DL, Drossman DA, Covington PS. Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients. Health Qual Life Outcomes. 2013;11(1):1-12.
5. Furiex Pharmaceuticals, Inc. Eluxadoline (mu opioid receptor agonist and delta opioid receptor antagonist). www.furiex.com/pipeline/discoverydevelopment-pipeline/mu-delta. Accessed February 2014.