FDA Roundup: New Options for IBS and COPD
Xifaxan (rifaximin) and Viberzi (eluxadoline)—Irritable Bowel Syndrome-D
The Food and Drug Administration (FDA) has approved 2 new treatments, Viberzi (eluxadoline) and Xifaxan (rifaximin), for the treatment of irritable bowel syndrome with diarrhea (IBS-D).1
“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.
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“The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors,” she said.1
The drug rifaximin can be taken orally 3 times a day for a 14-day period for the treatment of IBS-D symptoms that include diarrhea and abdominal pain, while eluxadoline is taken orally 2 times a day with food.1
Rifaximin is an antibiotic that was previously approved to treat traveler’s diarrhea from E. coli and to decrease risk of recurring overt hepatic encephalopathy, and eluxadoline works by activating receptors in the nervous system to decrease bowel contradictions in adults with IBS-D. 1
To determine the safety and effectiveness for rifaximin, researchers conducted 2 double-blind, placebo controlled trials in which 1258 patients were assigned either rifaximin or placebo. Those who received rifaxmin had significantly improved symptoms, compared with those taking placebo.
The safety and effectiveness for eluxadoline was determined in 2 double-blind placebo-controlled clinical trials including 2425 patients who received eluxadoline or a placebo. Over a 26-week period, eluxadoline simultaneously decreased abdominal pain and improved stool consistency more effectively than the placebo.1
Common reactions to rifaximin included nausea, an increase in alanine aminotransferase, while common side effects of eluxadoline included constipation, abdominal pain, and nausea.1
Stiolto Respimat – COPD Treatment
The FDA has announced approval of Stiolto Respimat (tiotropium bromide and oloderaterol) inhalation spray to treat the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
“A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with STIOLTO RESPIMAT initiated at the time of diagnosis will improve lung function,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.2
To test the safety and efficacy of the inhalation spray, researchers conducted a 52-week phase 3 trial trials. The trials were double-blind, randomized trials that compared tiotropium bromide and oloderaterolto tiotropium RESPIMAT 5 mcg and oloderaterol RESPIMAT 5 mcg.2
The trials proved that tiotropium bromide and oloderaterol improved lung function at 24 weeks compared to treatment with tiotropium and oloderaterol alone.2
The most common adverse reactions were nasopharyngitis, cough, and back pain.2
—Michelle Canales Butcher
References:
1. FDA. FDA approves two therapies to treat IBS-D [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm. Accessed May 29, 2015.
2. Boehringer Ingelheim. FDA approves Boehringer Ingelheim’s STIOLTO RESPIMAT inhalation spray once-daily maintenance treatment for COPD [press release]. www.prnewswire.com/news-releases/fda-approves-boehringer-ingelheims-stiolto-respimat-inhalation-spray-as-once-daily-maintenance-treatment-for-copd-300088485.html. Accessed May 29, 2015.