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# Achelios Therapeutics Plans NDA for Topical Migraine Drug
- URL: https://www.fdaweb.com/achelios-therapeutics-plans-nda-for-topical-migraine-drug/
- Published: 2017-06-14T12:00:00.000Z
- Updated: 2026-09-14T22:29:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138935

Achelios Therapeutics says it is planning a 505(b)(2) NDA for Topofen (ketoprofen), a topical formulation of the non-steroidal anti-inflammatory drug (NSAID) for treating acute and chronic migraine. The company says it recently completed a Phase 2a study demonstrating that topical application to facial areas innervated by trigeminal nerve branches may be a safe and effective alternative treatment for patients suffering from acute migraine. FDA and the company recently had a Type C meeting that the company says sought confirmation of the requirements for Phase 3 and an NDA submission. Currently there are no approved topical NSAIDs indicated for treating migraine.