FDA Approves Cefaly for Acute Treatment of Migraine
Findings demonstrated that on average, Cefaly treatment reduced migraine pain by 65% and 32% of patients were pain free within 1 hour.
Cefaly Technology announced that the Food and Drug Administration (FDA) has cleared for use the Cefaly Acute medical device for the treatment of migraines, with or without aura, in patients ≥18 years of age.
Cefaly Acute is an external trigeminal nerve stimulator (e-TNS) approved for use under prescription. It is placed on the forehead, sending micro-pulses through an electrode to the upper branch of the trigeminal nerve.
The device, initially FDA-approved for the prevention of migraine attacks, is now cleared for use during a migraine attack with or without aura. “We are excited that our medical technology is unique and can treat a migraine as well as prevent a migraine,” said Dr Pierre Rigaux, CEO of Cefaly Technology.
The approval was based on results from ACME (Acute Treatment of Migraine with External trigeminal nerve stimulation), a randomized, placebo control trial. Findings demonstrated that on average, Cefaly treatment reduced migraine pain by 65% and 32% of patients were pain free within 1 hour.
The Cefaly Acute device is expected be available in the next few months.
FDA releases Cefaly for acute treatment of migraine attacks [press release]. Cision: PR Newswire. http://www.prnewswire.com/news-releases/fda-releases-cefaly-for-acute-treatment-of-migraine-attacks-300523385.html Updated September 21, 2017. Accessed October 5, 2017.