Release date- 05082019 - The objective of this study is to compare plasma exposure in the first two hours following administration of dihydroergotamine mesylate (DHE) by INP104 (POD nasal), Migranal Nasal Spray, D.H.E. 45 (IV) or MAP0004 (oral inhalation) using data obtained from the STOP 101 study and literature reports.
PK results from STOP 101, a Phase 1, single dose, safety, tolerability, and bioavailability study of healthy subjects who received INP104 (1.45 mg), Migranal Nasal Spray (2.0 mg), or D.H.E. 45 IV (1.0 mg) in a 3-way, 3-period crossover were compared.
Dihydroergotamine (Migranal, D.H.E. 45
) is available for injection and nasal spray.
Dihydroergotamine mesylate Paddock Laboratories D.H.E. 45
Same drug is marketed as D.H.E. 45
for subcutaneous, intramuscular, or intravenous injection.
Others are dihydroergotamine (Migranal, D.H.E. 45
), ergotamine (Ergomar) (alone or in combination with caffeine, or caffeine-belladonna-pentobarbital), intranasal lidocaine, and selective serotonin receptor agonists, also called triptans.
ABORTIVE THERAPY DRUG DOSAGE 100% oxygen 7-8 L/min; maximum 5-10 min/hr sumatriptan 6 mg SC, self-injected; maximum two (Imitrex) injections per 24 hours at least 1 hour apart One 20-mg spray into one nostril; maximum 40 mg/24 hr dihydroergotamine 1 mg SC, self-injected (D.H.E. 45
); maximum two injections per 24 hours at least 1 hour apart 1-mg spray in each nostril (2 mg total, Migranal); repeat in 15 minutes if needed; maximum 4 mg/24 hr butorphanol nasal 1-mg spray in one nostril; repeat as spray needed, waiting at least 60 minutes (Stadol NS) between doses PREVENTIVE THERAPY prednisone 60 mg/day to start, tapering by 10 mg every other day for 5-10 days verapamil 80 mg t.i.d.