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- dihydroergotamine intranasal (STS101) / Satsuma Pharma
Pharmacokinetic Comparison of STS101 (A Novel Investigational DHE Nasal Powder) with Liquid Nasal, Injectable and Oral Inhaled DHE Formulations (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_3855;
STS101 demonstrated greater PK values and less PK variability compared to the approved DHE LNSs. As compared with MAP0004, STS101 achieved similar Cmax, higher AUC at all time points after ~30 minutes and similar PK variability.
- dihydroergotamine mesylate injection / Generic mfg.
[VIRTUAL] The Efficacy of Dihydroergotamine versus Emerging Acute Migraine Medications () - Jul 15, 2020 - Abstract #AHS2020AHS_272;
However, DHE use has been limited by route of administration and/or performance of approved dosage forms. Newer investigational products, such as STS101 (intranasal DHE powder), that demonstrate Cmax and drug exposure comparable to or greater than MAP0004, may overcome these limitations and provide more consistent and reliable clinical performance.
- | Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir, Semprana (dihydroergotamine oral inhalation) / Allergan
Journal: The discovery and development of inhaled therapeutics for migraine. (Pubmed Central) - Mar 5, 2020
In phase 2 trials, inhaled prochlorperazine shows good pharmacokinetics and efficacy, in contrast to inhaled loxapine that did not provide encouraging results in terms of efficacy. The authors see the potential for the use of dihydroergotamine mesylate in clinical practice pending regulatory approval.
- Comparison of Early Plasma Exposure to DHE for Marketed and Development Stage Nasal, Inhalation, and Injectable Products () - Jan 21, 2020 - Abstract #AAN2020AAN_1620;
INP104 AUC0-2hr potentially enables rapid and sustained pain relief, as validated by the MAP0004 clinical program. The lower Cmax following INP104 treatment vs IV may lead to improved tolerability.
- dihydroergotamine intranasal (STS101) / Satsuma Pharma, dihydroergotamine mesylate injection / Generic mfg.
Pharmacokinetic Comparison of STS101, an Intranasal Dry Powder Formulation of Dihydroergotamine, with Other Intranasal, Injectable and Oral Inhaled DHE Formulations () - Jan 21, 2020 - Abstract #AAN2020AAN_1619;
Lower PK variability may lead to more consistent and reliable clinical performance. A large Phase 3 efficacy study with STS101 is ongoing to evaluate the product as an acute treatment for migraine (NCT 03901482).
- ||||| Semprana (dihydroergotamine oral inhalation) / AbbVie
Enrollment change: FREEDOM301: Phase 3 Study of MAP0004 in Adult Migraineurs (clinicaltrials.gov) - Nov 5, 2013
P3, N=902, Completed, Sponsor: Allergan
A large Phase 3 efficacy study with STS101 is ongoing to evaluate the product as an acute treatment for migraine (NCT 03901482). N=1195 --> 902
- | Semprana (dihydroergotamine oral inhalation) / AbbVie
New P1 trial: Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole (clinicaltrials.gov) - Nov 7, 2011
P1, N=24, Completed, Sponsor: Allergan