Designed to overcome these shortcomings
and treatment limitations imposed by gastrointestinal signs and symptoms, the NP101 patch avoids the need for oral administration, does not depend upon gastrointestinal absorption, and provides more consistent, predictable plasma concentrations than oral and intranasal formulations of sumatriptan and a lower maximum plasma concentration than sumatriptan injection. Methods.— Patients diagnosed with migraine who had participated in a randomized, double-blind, Phase III study of the NP101 patch were given the option to use NP101 to treat migraine episodes with moderate or severe headache pain for up to 12 months in this open-label trial. Tyrosine Kinase Inhibitor Library chemical structure Results.— One hundred eighty-three patients applied 2089 study patches. The most common adverse events involved the patch application site (45% of patients). The only non-application-site adverse events reported in >2% of patients were nausea (n = 6, 3.3%), upper respiratory tract infection (n = 6, 3.3%), and nasopharyngitis (n = 4, 2.2%). FGFR inhibitor The incidence of triptan-associated adverse events was 1.6%. Across all visits for investigator assessments, the majority of patients (ranging from 74.7% at Month 1 to 92.2%
at Month 9) were scored as having no erythema at patch application sites. For patient assessments, the percentage of patch placement sites scored as having no or minimal redness was 38.2% at the time of patch removal and 65.4% 24 hours after patch activation. Two hours
after patch activation across all patch treatments over the 12-month study, 23.8% of initial acute migraine episodes were scored as being free from headache pain, 58.2% as having headache selleck chemicals llc pain relief,78.9% as nausea free, 60.1% as phonophobia free, 53.4% as photophobia free, and 20.7% as migraine free. No evidence of waning tolerability or efficacy was observed over the 12-month study period. Conclusion.— NP101, a transdermal sumatriptan formulation in development for the acute treatment of migraine, demonstrated tolerability and efficacy with successive uses over 12 months in this clinical trial. “
“(Headache 2011;51:295-299) “
“Migraine is a prevalent and disabling episodic brain state with protean symptoms dominated by headache. When migraine attacks are frequent or severe over a sustained period, use of daily preventive medications are indicated to significantly reduce disability and improve quality of life. Recently issued evidence-based guidelines outline an array of pharmaceutical and complementary treatment choices with data establishing them as effective or probably effective for prevention of episodic or menstrually associated migraine. OnabotulinutoxinA is the only Food and Drug Administration-approved medication for the prevention of chronic migraine. “
“(Headache 2011;51:1191-1201) Background.