If you suffer from debilitating headaches and/or migraines, you’re not alone. In fact, migraine is a leading cause of disability. Yet, currently available acute migraine drugs or devices typically only provide complete relief about 1/3 of the time. Clearly, there is much room (and need) for improvement.
Current options 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. Furthermore, studies have also shown that non-chronic migraine patients who do not effectively treat their migraines are more likely to progress to become chronic.
With numerous migraine therapy options on the market, when someone says they have a breakthrough alternative, many weary patients may tend to feel doubtful and question the chances. Except, of course, when the word “breakthrough” is associated with a special designation by the FDA. This offers legitimacy and, most importantly, offers hope.
What is the Breakthrough Device for Migraines?
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. The company recently announced, in April 2022, its latest cutting-edge device. This device uses gentle, controlled puffs of air in the ears (called “Automated Variable Pulse Insufflation™” or “AVPI”); and it was officially designated by the FDA as a “Breakthrough Device” for the acute treatment of migraine by patients 18 years or older.
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. This breakthrough has the potential to help a significant amount of people who suffer from debilitating migraines!
“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 with 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 Migraine 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.