Nerivio Receives FDA Clearance of Expanded Indication to Cover Chronic Migraine Patients Reports Theranica

October 26, 2020

Nerivio has received FDA clearance of expanded indication to cover chronic migraine in people 18 years and older. The news was announced today by Theranica.

Nerivio now has clearance for use in acute treatment of migraine with or without aura in patients 18 years of age or older, without limitation to episodic migraine. The clearance is supported by results from two clinical studies with chronic migraine patients.

“The updated Nerivio indication is an important development for patients with chronic migraine” said Prof. Stephen Silberstein, MD, director of the Headache Center at the Jefferson University Hospital in Philadelphia, who also serves on Theranica’s Medical Advisory Board. “When chronic patients find an effective treatment, they must limit its use every month to avoid loss of effectiveness and a risk of medication overuse headache. Availability of an additional treatment option such as Nerivio provides an important additional tool to address this patient population.”

Prof. Silberstein further commented, “with over one thousand treatments by 130 chronic migraine patients across two open-label studies with Nerivio, the data is clinically relevant.”

There are four million chronic migraine patients in the United States. Each year, around 2.5% of the 38 million people with episodic migraine transition into chronic migraine.

Chronic migraine is defined by at least 15 headache days per month, eight of which are migraine. Most acute migraine prescription pharmaceuticals have a limit of eight to ten monthly doses to avoid medication overuse headache (MOH). This new indication offers people with chronic migraine a non-pharmaceutical treatment option. Nerivio has been shown in clinical trials and a largescale post-market surveillance to have efficacy in treating migraine similar to prescribed migraine medicine, without risks of medication overuse.

“It is so important for people living with chronic migraine to now have access to this effective non-pharmacological therapy”, said Nancy Harris Bonk, a migraine patient advocate, and educator, who serves as Chief Operating Officer of Chronic Migraine Awareness, Inc. “With migraine attacks occurring so frequently, we, people with chronic migraine, need to be mindful of overusing medications and identify the right individual balance of therapies that allows us to carry on with our daily routines.”

Theranica’s FDA-cleared prescribed therapeutic wearable Nerivio uses Remote Electrical Neuromodulation (REN) to activate the brain’s Conditioned Pain Modulation (CPM) (an intrinsic Pain Inhibition Mechanism) to treat pain and accompanying migraine symptoms. Nerivio is one of TIME’s best inventions of 2019.

“Since the neurotransmitters released as a result of REN triggering the CPM mechanism are strong analgesics, it is not surprising to see evidence that this treatment approach is effective in chronic migraine patients as well,” said Rami Burstein, PhD., professor of Anesthesia, Harvard Medical School, and Vice-Chair of Neuroscience in the Department of Anesthesia, Critical Care and Pain Medicine in Beth Israel Deaconess Medical Center in Boston, who also serves on Theranica’s medical advisory board.

“With this indication expansion, Theranica is now broadening market access of Nerivio in the USA, including health insurance reimbursement,” said Theranica CEO Alon Ironi. “It’s time to provide physicians and patients affordable access to a safe non-pharmacological acute treatment.”

Currently, a Nerivio prescription can be obtained through any licensed healthcare provider, including via online telemedicine consultation platforms. Nerivio is delivered directly to the patient’s home. Each Nerivio is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new dispensed device.


Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that 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 purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.


"Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions," said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. "We're now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions."
The recent FDA clearances included Brainomix 360 e-CTP and Brainomix 360 e-MRI, both software modules that can support thrombolysis and thrombectomy treatment decisions, particularly for late-window patients who present to hospital more than 6-12 hours after stroke onset.
IONIC Health’s 510(k)-pending nCommand Lite technology is designed to include vendor-agnostic remote scanning capabilities. This strategic collaboration’s goal is to enable GE HealthCare to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems and patients around the globe.
Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT.
"This is the culmination of years of research and development to deliver a medical device that helps improve the lives of patients suffering from spinal stenosis. Our recent move to larger premises in the Research Park at FAU will allow us to train our surgical and distribution partners to become increasingly competitive in the spinal implant device market,” said Peter Harris, founder and CEO of FloSpine.

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