Twelve-month tolerability and efficacy study of np101, the sumatriptan iontophoretic transdermal system
Headache: The Journal of Head and Face Pain, 05/04/2012
Smith TR et al. – 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.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.
- 183 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%).
- 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 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.