MONTCLAIR, N.J. and NETANYA, Israel, Oct. 26, 2020 /PRNewswire/ -- Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced that its Nerivio® medical device has received Food and Drug Administration (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.
"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."
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.
Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side effect electroceuticals for idiopathic pain conditions. The company's award-winning flagship product, Nerivio®, is the first FDA-cleared smartphone-controlled prescription wearable device for acute treatment of migraine. Setting the foundation of an effective first-line therapeutic option within the migraine industry, Theranica is expanding its proprietary technology to offer additional solutions for other pain conditions. Nerivio has CE and FDA clearance for use in acute treatment of migraine with or without aura in patients 18 years of age or older.