Wednesday, April 27, 2022
With so many migraine therapies on the market, when someone says they have a breakthrough, patients tend to take it with a grain of salt. Except, of course, when the word "breakthrough" is associated with a special designation by the FDA. Today, Nocira is pleased to announce its device, which uses gentle, controlled puffs of air in the ears (called "Automated Variable Pulse Insufflation™" or "AVPI"), was officially designated by the FDA as a "Breakthrough Device" for the acute treatment of migraine by patients 18 years or older.
What's the Breakthrough Device Program?
The Breakthrough Device program aims to provide patients and health care providers with timely access to more effective medical devices by speeding up their development, assessment, and review process for FDA clearance or approval.
Only two other prior Breakthrough Device designations have been announced specifically for migraine. However, both were limited to only preventative use, and for only "chronic" migraine patients (at least 15 headache days per month). Nocira now becomes the first company to announce the FDA breakthrough designation for a device that is used (a) to acutely treat migraine attacks when they occur, and (b) by all (both chronic and non-chronic or "episodic") adult migraine patients.
"In granting this Breakthrough Device designation, the FDA was required to determine that the clinical data supporting the Nocira device provides a reasonable expectation for a more effective treatment versus other available therapies for acutely treating migraine attacks," says Melissa Walker, MS RAC FRAPS, Nocira's VP of Regulatory, Quality, and Clinical Affairs.
The Clinical Data
Nocira's Breakthrough Device designation was supported by peer-reviewed, published clinical data from a 59 patient, randomized, placebo or "sham"-controlled study. In only 20 minutes from using Nocira's device, headache relief rates were already very high (Nocira treatment vs. sham treatment):
60% vs. 7% had complete freedom from headache pain; and
90% vs. 31% had "significant" headache pain relief (at least 50% pain reduction).
Headache relief rates at only 2 hours from starting treatment were even higher:
67% vs. 7% had complete freedom from headache pain; and
93% vs. 31% had significant headache pain relief.
These successful patient outcomes were also about 20-47% higher than published relief rates from other trials for other currently available drugs and devices.
Complete freedom from other primary migraine symptoms (i.e., nausea, light sensitivity, and sound sensitivity) was also rapidly achieved for most migraine attacks treated with the Nocira device. High relief rates were also observed in both chronic and episodic migraine patients, and for migraines that were either with or without "aura" (certain visual disturbances). No significant safety issues were reported, and >90% of study participants reported a comfortable experience from the Nocira AVPI migraine treatment.
According to Stewart Tepper MD, Neurology Professor and Headache Center Director at Dartmouth and an advisor to Nocira, "From my perspective as a headache specialist, and based on my understanding of the Nocira device and its published clinical data, it seems appropriate and no surprise that this precedential Breakthrough Device designation was granted by the FDA for using the Nocira device to acutely treat migraine."
Accelerated Plans for the Nocira Breakthrough Device
According to Melissa Malker, "The breakthrough designation provides for a more interactively efficient and prioritized FDA pre-market review and approval process."
"Nocira is deeply appreciative of the FDA for its timely review and precedential recognition of our novel AVPI platform as a Breakthrough Device for acute treatment of migraine," says Jim Peacock, Nocira CEO. "This will clearly help us expedite the next remaining steps ahead for regulatory and commercialization pathways for making this disruptive new Nocira device available to tens of millions of migraine sufferers in the future."
Nocira is continuing more advanced clinical development and evaluations, and plans to submit for FDA pre-market review and authorization within the year.
Migraine is a leading cause of disability, women's health issues (3:1 prevalence vs. men), ER visits, sleep disorders, anxiety/depression, and opioid misuse. Yet, currently available acute migraine drugs or devices typically only provide complete relief about 1/3 of the time. They can also have side effects or otherwise be unpleasant to use – often resulting in patient dissatisfaction and poor patient compliance in using their prescribed therapies. Studies have also shown that non-chronic migraine patients who do not effectively treat their migraines are more likely to progress to become chronic.
About the Nocira AVPI Device
The patented Nocira AVPI system is completely non-invasive and drug-free, and treats migraine attacks by controlling gentle pressure changes in the external ear canal. This therapeutically stimulates a unique combination of pressure-responsive nerve pathways from the ear into areas of the brain associated with headache pain and other migraine symptoms. The novel approach uses a mobile phone 'app' to control a small, pocketable air pressure device to control the subtle ear pressure changes through comfortable earpieces that are connected to the device via thin tubes. The device is also comfortable and easy to use, and looks more like listening to music via wired earphones vs. using a medical device. The app also responds to patient inputs about their specific migraine symptoms to then customize the personalized Nocira therapy to optimally treat each migraine attack in each patient.
About Nocira LLC
Nocira is an Arizona-based, pre-market medical device company committed to developing safe and rapidly effective, drug-free treatments for migraine headaches and other neurological disorders. Nocira has continued to innovate and conduct clinical research for its pioneering new ear pressure-based neuromodulation approach for more than half a decade. More information is available at www.nocira.com.
Notices and Disclaimers
All statements above are subject to these Notices and Disclaimers. Reference to clinical trial results only reflect outcomes for the patient population and their medical management included in the trial, and are not necessarily predictive of outcomes in other patients with different characteristics and for whom results may differ. Forward looking statements and forecasts are estimates only, are subject to various risk factors, and are not necessarily predictive of actual future performance or results, which may vary from forecasts. This is not a solicitation for investment in, or offer to sell any securities of, Nocira LLC.
Patented and patent pending products of Nocira, LLC. NOCIRA® is a registered trademark, and other terms marked with "™" are also trademarks, of Nocira LLC. Copyright © 2022 Nocira LLC (All Rights Reserved)