The FDA announced today that it permits marketing of the first medical device to help reduce functional abdominal pain for patients 11 to 18 years of age with irritable bowel syndrome when combined with other therapies for the syndrome.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.
According to an FDA press release, the IB-Stim is a prescription-only device made up of a small, single-use electric nerve stimulator that is placed behind the patient’s ear. The device contains a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves, which is thought to provide pain relief.
According to the Innovative Health Solutions website, IB-Stim is intended to be used for 120 hours per week up to 3 consecutive weeks and targets cranial nerves V, VII, IX and X.
The FDA reviewed data from a published clinical study involving 50 patients with IBS 11 to 18 years old. Twenty-seven patients were treated with the device, and 23 received a placebo device. During the study, patients could continue stable doses of medication to treat chronic abdominal pain.
The study evaluated changes from baseline to the end of the third week in worst abdominal pain, usual pain and Pain Frequency Severity Duration Scores (PFSD), according to the FDA.
Pain at baseline was similar between the two cohorts. Patients in the IB-Stim cohort experienced a greater improvement in pain from baseline to week 3. Greater change was also demonstrated in composite PFSD scores in the IB-Stim group compared with the placebo group.
Fifty-two percent of the patients in the IB-Stim group compared with 30% of placebo patients experienced at least a 30% decrease in usual pain at the end of 3 weeks. Additionally, 59% of patients in the device cohort compared with 26% of patients in the placebo cohort experienced at least a 30% decrease in worst pain, according to the release.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in the release. “Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”