Nerivio receives clearance of expanded indication to cover chronic migraine patients

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, has announced that its Nerivio medical device has received FDA clearance for an expanded indication encompassing acute treatment of chronic migraine in people 18 years and older.

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. 

Professor Stephen Silberstein, MD, Director of the Headache Center at the Jefferson University Hospital, said: “The updated Nerivio indication is an important development for patients with chronic migraine. 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.

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

Nancy Harris Bonk, COO, Chronic Migraine Awareness, Inc., added: “It is so important for people living with chronic migraine to now have access to this effective non-pharmacological therapy. 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.”

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

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

Each Nerivio is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new dispensed device.