[33] Among patients who had a migraine effect (n = 7), patients treated with oral sumatriptan experienced large decreases in Cmax, AUC0-4, AUC0-12,

and AUC0-inf during an attack compared with a non-migraine period. The changes for patients treated with transdermal sumatriptan were relatively minor, and there was a small increase in AUC0-4. Because the migraine effect on Talazoparib in vivo the oral formulation was much greater than the transdermal formulation, Wilks et al concluded that sumatriptan TDS provides a more consistent and predictable means of delivering sumatriptan than oral formulations.[33] In a randomized, open-label, parallel-group, phase I study conducted to identify clinically significant differences in the PK of sumatriptan TDS in elderly vs young adults, elderly subjects treated with sumatriptan

TDS had slightly higher, but clinically insignificant, sumatriptan plasma levels (Cmax 104%; AUC0-inf 115%) than in young adults.[34] The pharmacological profile for sumatriptan TDS was expanded with findings from a phase I, single-center, open-label, randomized, single-dose study comparing the PK of sumatriptan TDS with and without controlled heat.[35] In this study, each of the 12 subjects used sumatriptan TDS twice: once with see more a 40°C heat wrap placed over the top of the patch for the 4-hour application wear time and once without the heat wrap. The median times to therapeutic sumatriptan levels (10 ng/mL) were 31.8 minutes with heat and 32.7 minutes without heat. With PK parameters well within the range for bioequivalence, these results showed that the addition of heat does not alter drug exposure, a result consistent with the known properties of iontophoresis and distinct from passive transdermal dermal systems, in which heat can cause potentially dangerous increases in exposure.[35] The efficacy of PtdIns(3,4)P2 sumatriptan TDS was evaluated in a randomized, parallel-group, double-blind, placebo-controlled, phase III trial in 530 generally healthy

men and women aged 18-66 years of age who had been diagnosed before age 50 years with migraine with or without aura according to criteria set forth in the International Classification of Headache Disorders.[36] Results showed that a significantly higher proportion of patients who received sumatriptan TDS were headache pain-free 2 hours after patch activation compared with placebo (18% vs 9%, respectively; P = .009); the significant difference from placebo continued for all subsequent time points up to and including 12 hours after patch activation (P ≤ .0357).[36] Significantly more sumatriptan TDS patients than placebo patients had headache pain relief at 2 hours post-dose (52.9% vs 28.6%, respectively; P < .