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# Promius Pharma NDA for Migraine Drug
- URL: https://www.fdaweb.com/promius-pharma-nda-for-migraine-drug/
- Published: 2018-04-02T12:00:00.000Z
- Updated: 2026-09-14T23:56:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141122

Promius Pharma, a Dr. Reddy’s Laboratories subsidiary, has filed an NDA New for its migraine candidate DFN-02, an intranasal formulation of sumatriptan 10 mg and Aegis Therapeutics’ permeation-enhancing technology known as Intravail. “This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan,” the company says. The submission is based on data from a study in 107 subjects (Clinicaltrials.gov # NCT02856802) that showed a significantly higher proportion of subjects who experienced two-hour pain freedom with DFN-02 compared with placebo, according to the company.