(402) Evaluation of patients with acute migraine treated with diclofenac potassium for oral solution and who had nausea at time of dosing

Abstract

Diclofenac potassium for oral solution (Cambia®, Depomed, Newark, CA) is the only single-agent prescription non-steroidal anti-inflammatory drug (NSAID) approved for the acute treatment of migraine in adults. The formulation, which contains 50 mg of diclofenac potassium in a buffered powder dissolved in water prior to administration, was developed to provide faster absorption, shorter time to maximal plasma concentration (tmax), and faster onset of pain relief. The objective of this analysis was to examine the efficacy of diclofenac potassium for oral solution in patient subgroups. Data for primary and secondary endpoints at 2 hr (pain-free response, photophobia, phonophobia, nausea, and vomiting) were pooled from two Phase 3 studies. Subgroups analyzed included patients with nausea, photophobia, phonophobia, vomiting, or were confined to bed at dosing; experienced aura; or had used triptans within the previous 42 days (triptan users). Here we report on patients with nausea at time of dosing. Additional subgroup analyses will be presented. P-values were from Cochran-Mantel-Haenszel test (center stratified). The integrated population included 1272 patients—644 dosed with active drug and 628 dosed with placebo. The mean patient age was 39.8 yr; approximately 85% were female and 90% were Caucasian. At dosing, 783 (61.6%) patients were experiencing nausea. Pain-free response at 2 hr was similar in patients with or without nausea at the time of dosing (no nausea/nausea: active drug, 25.7/24.6%; placebo, 13.1/9.4%). Furthermore, for patients with nausea at dosing, more were nausea free at 2 hr than those treated with placebo (50.1% vs. 35.2%, p<0.001), photophobia free (44.8% vs. 33.4%, p=0.002), and phonophobia free (50.9% vs. 36.0%, p<0.001). In conclusion, by 2 hr, patients with migraine who experience nausea at time of dosing reported pain relief at the same rates as patients without nausea, as well as reductions in rates of nausea, photophobia, and phonophobia. Diclofenac potassium for oral solution (Cambia®, Depomed, Newark, CA) is the only single-agent prescription non-steroidal anti-inflammatory drug (NSAID) approved for the acute treatment of migraine in adults. The formulation, which contains 50 mg of diclofenac potassium in a buffered powder dissolved in water prior to administration, was developed to provide faster absorption, shorter time to maximal plasma concentration (tmax), and faster onset of pain relief. The objective of this analysis was to examine the efficacy of diclofenac potassium for oral solution in patient subgroups. Data for primary and secondary endpoints at 2 hr (pain-free response, photophobia, phonophobia, nausea, and vomiting) were pooled from two Phase 3 studies. Subgroups analyzed included patients with nausea, photophobia, phonophobia, vomiting, or were confined to bed at dosing; experienced aura; or had used triptans within the previous 42 days (triptan users). Here we report on patients with nausea at time of dosing. Additional subgroup analyses will be presented. P-values were from Cochran-Mantel-Haenszel test (center stratified). The integrated population included 1272 patients—644 dosed with active drug and 628 dosed with placebo. The mean patient age was 39.8 yr; approximately 85% were female and 90% were Caucasian. At dosing, 783 (61.6%) patients were experiencing nausea. Pain-free response at 2 hr was similar in patients with or without nausea at the time of dosing (no nausea/nausea: active drug, 25.7/24.6%; placebo, 13.1/9.4%). Furthermore, for patients with nausea at dosing, more were nausea free at 2 hr than those treated with placebo (50.1% vs. 35.2%, p<0.001), photophobia free (44.8% vs. 33.4%, p=0.002), and phonophobia free (50.9% vs. 36.0%, p<0.001). In conclusion, by 2 hr, patients with migraine who experience nausea at time of dosing reported pain relief at the same rates as patients without nausea, as well as reductions in rates of nausea, photophobia, and phonophobia.