LACK OF PHARMACOKINETIC INTERACTION BETWEEN BUTORPHANOL TARTRATE NASAL SPRAY AND SUMATRIPTAN SUCCINATE

The pharmacokinetics of butorphanol tartrate given in a nasal spray wi th and without the co-administration of sumatriptan succinate were stu died in 24 healthy men and women. In this crossover design study, all subjects received 2 treatments: a single 1-mg dose of butorphanol nasa l spray and a 1-mg dose of butorphanol nasal spray plus a single 6-mg subcutaneous (SC) dose of sumatriptan, There was a two-week washout pe riod between sessions. Serial blood samples were collected and plasma samples analyzed using validated radioimmunoassay and high-performance liquid chromatography/electrochemical procedures to determine the con centrations of unchanged butorphanol and sumatriptan, respectively. Th ere were no statistically significant differences for butorphanol betw een the 2 treat men ts on any of the following pharmacokinetic paramet ers: C-max, t(max), AUC, t(1/2), CL/f, and V-z/f. Similarly, the pharm acokinetic parameters obtained for sumatriptan (given with butorphanol nasal spray) were comparable with the literature values obtained for a single 6-mg SC dose of sumatriptan. These data show a lack of pharma cokinetic interaction between butorphanol nasal spray and sumatriptan. Butorphanol nasal spray and sumatriptan were well tolerated, The adve rse experience profiles of butorphanol nasal spray were comparable bet ween the treatments, with and without sumatriptan. It con be concluded that regimens of butorphanol nasal spray and sumatriptan need not be changed for either pharmacokinetic or safety considerations when the t wo compounds are co-administered in treating acute migraine attacks.