A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

New Study Suggests REN Comparable to Standard Care Prescribed Medications for Acute Treatment of Chronic Migraines

Analysis of Clinical Trial Data Shows No Difference in Effectiveness Outcomes Between Use of Remote Electrical Neuromodulation (REN) Device Nerivio® and Tested Medications

Theranica, a prescribed digital therapeutics company developing advanced digitally-connected neuromodulation devices for migraine and other pain conditions, announced today the publication of a new study comparing the effectiveness of Remote Electrical Neuromodulation (REN) to that of standard-care medications for the acute treatment of chronic migraine.

The post-hoc analysis published in the Journal of Pain Management concludes that REN, administered by Theranica’s flagship therapeutic wearable Nerivio provides an effective non-pharmacological alternative for standard-care abortive medications in individuals impacted by chronic migraine.

“Chronic migraine is an especially disabling condition, diagnosed when a migraine patient experiences at least 15 migraine-induced headache days per month,” said Brian Grosberg, MD, Director of the Hartford Healthcare Headache Program, who served as the primary investigator of the study. “The recent Consensus Statement of the American Headache Society recommends that, in order to avoid medication overuse, patients with migraine who need to use acute treatments on a regular basis should be instructed to limit medication use to an average of two headache days per week.”

Grosberg added, “Chronic migraine patients often have four, five or even six headache days per week. To treat them effectively and safely we must expand the first-line standard-care treatment options beyond prescribed medications. This research provides a strong comparison of REN to prescribed medications, mainly triptans, reinforcing the conclusion that REN provides a much-needed alternative to standard-care acute migraine treatment – without compromising effectiveness.”

Prospective data from 78 adult chronic migraine patients in the U.S. demonstrated effectiveness of REN across four parameters in comparison to standard-care medications. The analyzed parameters included single-treatment pain relief and pain-freedom post 2 hours, as well as consistent pain relief and pain freedom across multiple treatments. In 62.8% (49/78) of the patients, REN led to significant single-treatment pain relief two hours post treatment, as opposed to only 48.7% (38/78) with medication usage (p=0.056 [McNemar Test]). Additionally, 64.1% of the patients achieved consistent pain relief with REN, compared to 57.7% when using standard-care medications. Single treatment pain relief was achieved in 23.1% of migraine sufferers when using REN, in comparison to 19.2% with medication usage. Both REN and medication achieved 14.1% consistency of pain freedom across multiple treatments.

Worn on the upper arm at the onset of a migraine attack, Nerivio® uses REN technology to alleviate migraine headache and associated symptoms by triggering an endogenous analgesic mechanism, known as conditioned pain modulation (CPM). The device is controlled via a smartphone app, allowing patients to set the intensity of their treatment as well as maintain a built-in migraine diary that can easily be shared with physicians for improved migraine tracking and management.

“The results of this study further reinforce the very large body of evidence validating the efficacy of REN and Nerivio in various migraine patient populations,” said Ivan Gergel, MD, Managing Partner and CMO of New Rhein Healthcare Investors and a member of Theranica’s board of directors.  “This is very meaningful for health care and health insurance systems in the U.S. who always seek ways to provide their members with access to safe, effective therapeutics for chronic conditions.”

Nerivio is a prescribed, digitally connected wearable. Clinical studies have shown that Nerivio is effective and safe for the treatment of episodic and chronic migraine in individuals aged 12 and older.

SourceTheranica
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy