- Patients who received DFN-02 for migraine reported significantly greater reduction in migraine-related disability than placebo, and most reported greater satisfaction with DFN-02 than their usual migraine medication.
Why this matters
- DFN-02 is a 10 mg sumatriptan formulation nasal spray that is coformulated with a permeation enhancer, making it comparable with subcutaneous sumatriptan.
- This multicenter, randomized, double-blind, placebo-controlled trial evaluated 107 adults (age, 18-75 years) with episodic migraine who had 12-month history of 2-8 attacks/month, with ≤14 headache days monthly and ≥48 hours of headache-free time between attacks.
- Patients were randomly allocated to either DFN-02 or matching placebo spray.
- Funding: Dr. Reddy's Laboratories group of companies.
- Mean change in functional disability score at 2 hours postdose was significantly greater in the DFN-02 group vs placebo (−1.2 vs −0.6; P <.001>
- 56.3% vs 28.2% patients treated with DFN-02 vs placebo had no functional disability (P=.01) at 2 hours postdose.
- Mean 2-hour overall subject-rated treatment satisfaction scores were significantly better with DFN-02 vs placebo (2.8 vs 4.1; P=.003).
- At 24 hours postdose, patients reported significantly higher treatment satisfaction with DFN-02 vs their usual prestudy migraine medication (74.6 vs 62.2; P=.012).
- Small study population.
- Limited generalizability.
Coauthored with Antara Ghosh, PhD