NeurAxis Announces Results Of Comparative Study Of IB-Stim And Standard Medical Therapy In Adolescents With Functional Abdominal Pain Disorders

Author: Benzinga Newsdesk | September 26, 2023 09:21am

NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE:NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the results of a retrospective comparative study of adolescent patients with functional abdominal pain disorders (FAPD) treated with IB-Stim™ therapy or standard of care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). Led by the Cincinnati Children's Hospital Medical Center, the comparative study concluded that IB-Stim™ may be a good non-pharmacologic alternative for FAPD.

 

The publication, Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders, featured in the September 19th 2023 Frontiers in Pain Research, reviewed records of 101 adolescents treated with 4 weeks of IB-Stim™, amitriptyline or cyproheptadine. In the study, 59% of patients in the IB-Stim group had failed prior standard medical therapy. Evaluated outcome measures included validated pediatric questionnaires using Abdominal Pain Index (API), Nausea Severity Scale (NSS) and Functional Disability Inventory (FDI) at baseline and at 3-month follow up. The comparative analysis noted that:

• at follow up, IB-Stim™ therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034);
• in a comparison of outcomes between groups, IB-Stim™ was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); and
• disability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim™ (p=0.21).
  
   

Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, said, "It is exciting to see a comparative evaluation of IB-Stim™ with standard medical therapy. Although amitriptyline and cyproheptadine are amongst the most commonly used medications to treat functional abdominal pain, there is a lack of clinical evidence for using these medications in children and it may be that these medications just don't perform as well as we think". Dr. Miranda added, "it is difficult to know how a drug will perform in the real world, even after a positive clinical trial, because drugs are metabolized differently. This is one of the reasons drug trials need to be very large. More importantly, side effects need to be monitored closely, particularly in children. Nonetheless, we are pleased that IB-Stim™ continues to show positive clinical results with minimal to no side-effects, making it an effective FAPD treatment option."

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