NOCIRA announces breakthrough device designation by FDA for migraine treatment

pharmafile | April 28, 2022 | News story | Business Services  

NOCIRA is the first company to announce the FDA’s Breakthrough Device designation for the treatment of migraine attacks in both chronic and non-chronic migraine patients. The FDA’s Breakthrough Device program is designed to speed access for caregivers and patients to life-changing medical devices.

The Breakthrough Device designation was supported by peer-reviewed, published clinical data from a 59 patient, randomised, placebo-controlled study. After only 20 minutes of using Nocira’s device, headache relief rates were already very high. 60% versus 7% had complete freedom from headache pain, and 90% versus 31% had significant headache pain relief (at least 50% pain reduction).

Headache relief rates at two hours from the beginning of treatment were even higher: 67% versus 7% had complete freedom from headache pain 90% versus 31% had “significant” headache pain relief (at least 50% pain reduction).

Migraines are a leading cause of disability, predominantly occuring in women more than men. However, currently available acute migraine drugs or devices typically only provide complete relief about a third of the time.

According to Melissa Walker, MS RAC FRAPS, Nocira’s VP of Regulatory, Quality, and Clinical Affairs: “The breakthrough designation provides for a more interactively efficient and prioritised 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 commercialisation pathways, for making this disruptive new Nocira device available to tens of millions of migraine sufferers in the future.”

Lina Adams

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