The Food and Drug Administration (FDA) has cleared Regulora®, a prescription-only digital therapeutic, for the treatment of abdominal pain associated with irritable bowel syndrome (IBS) in adults 22 years of age and older.
Regulora is indicated as a 3-month self-administered treatment for patients with abdominal pain due to IBS and is intended to be used with other IBS treatments. Based on gut-directed hypnotherapy, Regulora provides seven 30-minute sessions of remote behavioral therapy delivered through a mobile app over a 12 week period.
The efficacy and safety of Regulora was evaluated in 362 patients with symptomatic IBS in a multicenter, randomized, double-blind, comparator-controlled, parallel-group clinical trial (ClinicalTrials.gov Identifier: NCT04133519).
In 2 out of 3 analyses, findings showed that the Regulora arm demonstrated clinically significant separation for the primary endpoint of abdominal pain compared with the control arm. Moreover, 68% of patients in the Regulora arm reported overall satisfaction with the treatment and 87% said they would recommend the digital therapeutic.
There were no serious adverse events associated with Regulora therapy. Abdominal pain, constipation, fatigue, and headache were reported in approximately 1% of study participants. The adherence rate was found to be 87% among those assigned to Regulora.
The Regulora digital therapeutic mobile app is compatible with both Apple and Android devices and is expected to be available in the first half of 2022.
metaMe Health receives FDA Clearance for Regulora®, the first FDA-authorized treatment specifically for abdominal pain due to irritable bowel syndrome (IBS). News release. November 30, 2021. https://www.metamehealth.com/press/metame-health-receives-fda-clearance-for-regulora-the-first-fda-authorized-treatment-specifically-for-abdominal-pain-due-to-irritable-bowel-syndrome-ibs.