Cefaly yesterday released data from a trial of its Cefaly Acute device designed for the acute treatment of migraines, touting that its migraine abortion capabilities outperformed current published data on triptans and other medical drugs under investigation for the acute treatment of migraines.
The New York City-based company’s flagship Cefaly Acute device is FDA-approved as an external trigeminal nerve stimulation device designed to prevent frequent episodic migraines. The device can also help patients who are normally unaffected by oral migraine medication.
Based on data from the trial, Cefaly said it is planning to move forward with a Phase 3 clinical trial in the US with hopes to complete the study by the end of 2018.
In the trial, researchers used a design identical to those used to test abortive migraine medication, including currently cleared medications such as Triptan and new drugs under investigation, the company said.
Results from the trial showed that 70.8% of patients treated with Cefaly Acute for two hours reported pain relief, with 35.4% of patients reporting being pain free. A total of 60.4% of patients reported freedom from the most bothersome symptoms.
Comparatively, data on the experimental Lasmiditan reported a 59% rate of pain relief in patients at 2 hours, with 32.2% reported as pain free and 40.9% were MBS-free. Other experimental pharmaceutical candidates reported similar results, Cefaly reported.
At 24-hours, sustained pain freedom reported with the Cefaly Acute was 25%, the company said.
“We’ve made huge technical advances in recent years that have led to new device generations that are much more efficient than before. Recent improvements led to the Cefaly Acute and now the new clinical data shows that it offers the best solution for the abortive treatment of migraine. We are very excited by these results and eager to begin Phase 3 to provide full evidence that Cefaly Acute as the first line abortive migraine therapy offers better efficacy than the triptans, fulfilling patients’ unmet needs, and having next-to-no side effects, while remaining the cheapest overall treatment,” CEO Dr. Pierre Rigaux said in a press release.