DFN-15 may be effective in relieving migraine
Treatment with DFN-15 may effectively alleviate pain and the most bothersome symptoms in adults with episodic migraine, according to two phase III studies presented at AHS 2020.
“DFN-15, a 120 mg oral celecoxib solution has demonstrated rapid absorption in healthy subjects, … [but] the efficacy of celecoxib, a selective COX-2 inhibitor, for episodic migraine has not been established,” according to study investigator Dr Sagar Munjal from Dr. Reddy’s Laboratories Incorporated in Princeton, New Jersey, US.
The researchers conducted two identical, multicentre, double-blind, phase III studies involving adults with episodic migraine (2–8 per month) to assess the efficacy and safety of DFN-15 in these patients. Participants were randomized to receive either DFN-15 or placebo (study 1; n=631) and were then rerandomized in a second double-blind study period (study 2; n=622). Of these, only 80.5 percent (study 1) and 80.1 percent (study 2) completed the study treatment. [AHS 2020]
A significantly higher percentage of individuals on DFN-15 were pain free at 2 hours post-dosing than those on placebo in study 1 (32.8 percent vs 23.5 percent; p=0.02) and study 2 (35.6 percent vs 21.7 percent; p<0.001).
More subjects in the DFN-15 arm vs the placebo arm also experienced freedom from the most bothersome symptom (eg, nausea, photophobia, and phonophobia) at 2 hours post-dosing in both studies (58.1 percent vs 43.9 percent; p=0.003 in study 1 and 57.8 percent vs 44.8 percent; p=0.007 in study 2).
Similarly, more DFN-15-treated subjects experienced pain relief (moderate, severe to mild, or no pain at 2 hours) compared with placebo-treated patients in study 1 (67.9 percent vs 55.3 percent; p=0.004) and study 2 (74.5 percent vs 60.5 percent; p<0.001).
The rates of treatment-emergent adverse events (TEAEs) were comparable between the DFN-15 and the placebo groups (below 14 percent), with no serious TEAEs or deaths reported.
The researchers also found no remarkable findings in ECGs, vital signs, laboratory tests, or in any other safety endpoints.“[Overall,] in [the] two phase III placebo-controlled studies, … DFN-15 may be an effective alternative to oral triptans … [and was found to be] effective for the acute treatment of migraine,” Munjal concluded.