Furiex irritable bowel syndrome drug succeeds in large trials
Irritable Bowel Syndrome
Beyond that, stress tends to make people especially aware of uncomfortable or painful symptoms. Research has found that a history of stressful life events or current distress often precedes development of IBS. Other studies have found that people developed psychiatric disorders prior to, or at the same time as, IBS symptoms. The most common psychiatric disorders among IBS patients are depresion and anxiety. These disorders typically respond well to treatment, and if left untreated can make IBS symptoms worse. Treatment options include psychotherapy or counseling and medications, such as antidepressants. One form of psychotherapy, cognitive behavioral therapy, has shown promise for patients with moderate to severe IBS and for those with IBS and anxiety or mood disorders. CBT can help patients learn coping strategies to control the symptoms brought on by anxiety. Patients work with a therapist to modify their thinking about stressful situations and their perceptions about their gastrointestinal symptoms. As patients’ cognitive appraisal of their reality changes, their bowel symptoms often improve. Other stress management options include: Relaxation training, such as meditation, guided imagery, or biofeedback Regular exercise, including walking or yoga Breathing techniques Getting enough sleep on a regular schedule A diary may help you recognize stressors that activate symptoms. The diary should include the symptom experienced and its severity; associated factors such as diet, activity, or stress; emotional response (feelings of anger, sadness, helplessness); and thoughts associated with the incident. A record of stressors and associated responses may help you figure out positive ways to better deal with the stressors.
Furiex said it expected to seek European approval in early 2015. The company’s shares rose as much as 165 percent to $121.97, valuing it at about $1.3 billion. “We believe that there are a lot of patients out there who need this drug. There is a huge unmet need,” Furiex Chief Medical Officer June Almenoff said in a telephone interview. Currently approved drugs for IBS address constipation associated with the disorder, but there are few options for diarrhea predominant IBS. Furiex founder and chairman Fred Eshelman said he believes the drug has the potential for blockbuster sales, which he defined as annual sales of between $750 million and $1 billion. Eluxadoline was tested at two doses against a placebo over the course of 12 weeks to meet requirements by the U.S. Food and Drug Administration, and for 26 weeks for European health regulators, in Phase III studies involving 2,428 patients, Furiex said. For the combined goal of improvement in abdominal pain and stool consistency for at least half the days in the study, eluxadoline achieved a statistically significant improvement at the 100 milligram and 75 mg doses through 12 weeks in both studies. On the 26-week measure, the higher dose succeeded in both studies but the lower dose missed statistical significance in one of the two trials, according to initial results released by the company. The success appeared to be driven by the percentage of patients reporting improvements in diarrhea, which ranged from 30 percent to 37 percent versus 22 percent and 20.9 percent for the placebo groups. When the composite goal was broken into its two components, researchers found a numerical improvement in pain response rates that did not achieve statistical significance. The drug appeared to be safe and well-tolerated in both studies, Furiex said. The most commonly reported side effects were constipation and nausea. The company plans to present a far more detailed analysis of the late stage studies at an upcoming medical meeting. “We’re very excited about the path ahead and about how this can transform patients’ lives,” Almenoff said.