The US Food and Drug Administration (FDA) has granted breakthrough designation for Nocira’s hand-held device to treat acute migraine in patients aged 18 years or above.
Named Automated Variable Pulse Insufflation (AVPI), the device uses gentle, controlled puffs of air in the ears to treat migraine attacks.
A non-invasive and drug-free device, the AVPI system treats migraine attacks by regulating gentle pressure changes in the external ear canal.
This therapeutically triggers a mixture of pressure-responsive nerve pathways from the ear into parts of the brain linked to headache pain and other migraine symptoms.
The new approach leverages a mobile phone application to regulate the small, pocketable air pressure device, which controls the slight ear pressure changes through earpieces.
These earpieces are attached to the device using thin tubes.
Furthermore, the app responds to the user’s inputs regarding their migraine symptoms to subsequently tailor the personalised Nocira therapy to treat each migraine attack.
With the latest development, Nocira became the first firm to obtain FDA breakthrough device status for the treatment of adult patients with chronic and non-chronic migraine attacks.
The FDA granted the status based on clinical data from 59 patients in a randomised, placebo (sham)-controlled trial.
Findings showed that just 20 minutes of using the device offered high headache relief rates versus sham treatment.
Nearly 60% of the subjects who received the Nocira treatment for 20 minutes had complete freedom from headache pain, versus 7% in the sham treatment arm.
In addition, treatment with the Nocira device provided complete freedom from other primary migraine symptoms quickly.
The company is advancing clinical development and assessments to seek FDA pre-market review and authorisation for the device within the year.
Nocira CEO Jim Peacock said: “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.
“This will clearly help us expedite the next remaining steps ahead for regulatory and commercialisation pathways for making this disruptive new Nocira device available to tens of millions of migraine sufferers in the future.”