Enhanced sumatriptan nasal spray shows benefit in migraine

  • Lipton RB & al.
  • CNS Drugs
  • 15 Mar 2019

  • International Clinical Digest
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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).

Limitations

  • Small study population.
  • Limited generalizability.

Coauthored with Antara Ghosh, PhD

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