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Findings

What does this study add?

  • The proportion of subjects pain-free at 2 hours was significantly greater with DFN-15 than placebo in Study 2 (35.6% versus 21.7%; p<0.001) but not Study 1 (32.9% versus 25.8%, p=0.075).
  • For both studies, more subjects on DFN-15 were free from MBS at 2 hours post-dose compared to placebo (Study 1, 58.9% versus 45.0%; p=0.003 and Study 2, 57.8% versus 44.8%; p=0.007).
  • Similar trends were observed for pain relief (moderate or severe to mild or no pain) at 2 hours post-dose.
  • The TEAE rates were below 14%, dysgeusia being the most common.