I know this is migraine and not PD but this is really a dramatic breakthrough in neurology. I think the question has to be asked by patients and neurologists alike, is it still going to be ethical when these guys have accomplished their phase III trials to continue to research invasive expensive solutions? I pray the universe this comes to us, and we may then ask the same question.
medicaldesignandoutsourcing...
Ear-puffing device for migraine treatment wins FDA breakthrough designation
April 28, 2022
(In the picture, it's me, relaxed reading whilst my PD is being treated)
A woman with a small, handheld device in her lap with tubes that look like earphones plugged into hear ears.
Nocira’s AVPI migraine treatment device [Photo courtesy of Nocira]
A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA.
Tempe, Arizona–based Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up.
The device uses “gentle, controlled puffs of air in the ears” to subtly change pressure in the external ear canal, a drug-free technology that Nocira calls Automated Variable Pulse Insufflation (AVPI).
“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 company said yesterday in a news release.
A smartphone app controls the noninvasive, handheld air pressure device and responds to the patient’s input of migraine symptoms to customize treatment.
Nocira said it plans to submit for FDA premarket review and authorization within the year.
Breakthrough device designation “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 CEO Jim Peacock said in the news release.
Device developers that win breakthrough designation can opt to keep that status secret, but two other prior designations have been announced specifically for migraines, Nocira said. Both were limited to preventative use for chronic migraine patients, defined as those who experience 15 headache days per month.
“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,” Nocira VP of Regulatory, Quality, and Clinical Affairs Melissa Walker said in the news release.
In a peer-reviewed, published study with 59 patients randomly assigned treatment with the device or with a sham placebo, Nocira said 90% of patients had significant headache pain relief (defined as a 50% reduction in pain) within 20 minutes of using the device, a figure that increased to 93% over two hours.
Of the patients who used the device, 60% reported complete relief from headache pain within 20 minutes and 67% within two hours.
Of the patients in the sham group, 7% reported complete freedom from headache pain within 20 minutes and then 2 hours, while 31 percent reported significant relief in the same timeframe.
Nocira said the patient relief rates were 20% to 47% better than other published trials for 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,” the company said. “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).”
More than 90% of study participants said the Nocira migraine treatment was a comfortable experience, and there were no significant safety issues reported.
Nocira said it is continuing more advanced clinical development and evaluation efforts.
Nocira was founded in 2014 by Chief Scientific Officer David George, David Sullivan, George Buckler and Board Chair Tim Crown, who is Nocira’s lead investor and a co-founder of Insight Enterprises (Nasdaq:NSIT).
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