TY - JOUR
T1 - Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine
T2 - Results from the International Migraine Pain Assessment Clinical Trial (IMPACT)
AU - Lipton, Richard B.
AU - Grosberg, Brian
AU - Singer, Richard P.
AU - Pearlman, Starr H.
AU - Sorrentino, James V.
AU - Quiring, John N.
AU - Saper, Joel R.
N1 - Funding Information:
This study was supported and implemented by ProEthic Pharmaceuticals, Charlotte, NC, USA.
PY - 2010/11
Y1 - 2010/11
N2 - Objective: This study assessed the efficacy of diclofenac potassium for oral solution, a novel water-soluble buffered powder formulation, versus placebo for the acute treatment of migraine. Diclofenac potassium for oral solution has a time to maximum plasma concentration (Tmax) of 15 minutes, suggesting the potential for a rapid onset of therapeutic effects. Methods: This was a randomized, double-blind, parallel-group, placebo-controlled study conducted in 23 US centers. Adult sufferers with an established migraine diagnosis according to the International Classification of Headache Disorders, second edition (ICHD-II), treated one moderate or severe attack with 50 mg diclofenac potassium for oral solution (dissolved in approximately 2 ounces of water; N = 343) or matching placebo (N = 347). Four co-primary endpoints included the percentage of subjects who at two hours post-treatment reported no headache pain, no nausea, no photophobia and/or no phonophobia. Results: Significantly more subjects treated with diclofenac potassium for oral solution (N = 343) achieved a two-hour pain-free response (25% vs. 10%, p <.001), no nausea (65% vs. 53%; p =.002), no photophobia (41% vs. 27%; p <.001) and no phonophobia (44% vs. 27%; p <.001) compared to placebo. Pain intensity differences between treatments were significantly lower in the diclofenac potassium oral solution group, starting at 30 minutes post-treatment (p =.013) with significant differences at all time points thereafter (p <.001). Twenty-four-hour sustained pain-free response favored diclofenac potassium oral solution treatment versus placebo (19% vs. 7%, p <.0001). The most common adverse event considered to be treatment related was nausea (diclofenac potassium for oral solution [4.6%]; placebo [4.3%]). Conclusions: This study shows that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment.
AB - Objective: This study assessed the efficacy of diclofenac potassium for oral solution, a novel water-soluble buffered powder formulation, versus placebo for the acute treatment of migraine. Diclofenac potassium for oral solution has a time to maximum plasma concentration (Tmax) of 15 minutes, suggesting the potential for a rapid onset of therapeutic effects. Methods: This was a randomized, double-blind, parallel-group, placebo-controlled study conducted in 23 US centers. Adult sufferers with an established migraine diagnosis according to the International Classification of Headache Disorders, second edition (ICHD-II), treated one moderate or severe attack with 50 mg diclofenac potassium for oral solution (dissolved in approximately 2 ounces of water; N = 343) or matching placebo (N = 347). Four co-primary endpoints included the percentage of subjects who at two hours post-treatment reported no headache pain, no nausea, no photophobia and/or no phonophobia. Results: Significantly more subjects treated with diclofenac potassium for oral solution (N = 343) achieved a two-hour pain-free response (25% vs. 10%, p <.001), no nausea (65% vs. 53%; p =.002), no photophobia (41% vs. 27%; p <.001) and no phonophobia (44% vs. 27%; p <.001) compared to placebo. Pain intensity differences between treatments were significantly lower in the diclofenac potassium oral solution group, starting at 30 minutes post-treatment (p =.013) with significant differences at all time points thereafter (p <.001). Twenty-four-hour sustained pain-free response favored diclofenac potassium oral solution treatment versus placebo (19% vs. 7%, p <.0001). The most common adverse event considered to be treatment related was nausea (diclofenac potassium for oral solution [4.6%]; placebo [4.3%]). Conclusions: This study shows that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment.
KW - acute treatment
KW - buffered formulation
KW - diclofenac potassium
KW - migraine
UR - http://www.scopus.com/inward/record.url?scp=79551566037&partnerID=8YFLogxK
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U2 - 10.1177/0333102410367523
DO - 10.1177/0333102410367523
M3 - Article
C2 - 20959428
AN - SCOPUS:79551566037
SN - 0333-1024
VL - 30
SP - 1336
EP - 1345
JO - Cephalalgia
JF - Cephalalgia
IS - 11
ER -