FDA grants De Novo authorisation to Theranica's Nerivio Migra, a smartphone-controlled migraine wearable

Theranica/Nerivio

The FDA authorised Nerivio Migra, a prescription arm patch that delivers electrical pulses to sensory nerves for acute migraine, used at home at the onset of headache or aura. The pivotal trial met its primary endpoint of pain relief at two hours.

• 252-patient pivotal trial: 66.7% pain relief at two hours vs 38.8% placebo
• Significant on three of four secondary endpoints, including pain-free at two hours
• Theranica also closed a $35M Series B led by aMoon