Dihydroergotamine Nasal Powder Under Review for Acute Migraine Treatment


The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for STS101 (dihydroergotamine) for review. [DHE] Nasal powder) for acute treatment of migraine.

STS101 is an investigational DHE nasal powder product administered via a proprietary nasal delivery device. We believe the dry powder DHE formulation offers faster absorption and stronger effects compared to existing His DHE products. Dihydroergotamine is currently available as an injectable formulation and nasal spray.

The NDA is supported by data from a long-term, open-label Phase 3 study (ClinicalTrials.gov ID: NCT04406649) in 446 adults with a history of migraine with or without aura of at least one year. A total of more than 10,500 doses of STS101 were administered to treat over 9,000 migraine attacks for up to 18 months. Treatment-emergent adverse events reported during the study included nasal discomfort and taste disturbances, which were usually mild and transient.

The submission also included data from the double-blind, placebo-controlled Phase 3 SUMMIT trial (ClinicalTrials.gov Identifier: NCT04940390). Although the primary outcome was not considered statistically significant, treatment with STS101 resulted in pain relief at all time points (3, 4, 6, 12, 24, and 48 hours) after 2 hours of administration. demonstrated strong and lasting effects in providing relief from the most troublesome symptoms. time).

A regulatory decision is expected in January 2024.

References:

  1. Satsuma Pharmaceutical Co., Ltd. announced that it has received an FDA 505(b)(2) NDA for STS101, a novel investigational dihydroergotamine (DHE) nasal powder product for the acute treatment of migraine. news release. Satsuma Pharmaceutical. Accessed May 19, 2023. https://www.globenewswire.com/news-release/2023/05/18/2672216/0/en/Satsuma-Pharmaceuticals-Announces-FDA-Acceptance-of-505-b-2-STS101-a-Novel- His NDA on and-Investigational-Dihydroergotamine-DHE-Nasal-Powder-Product-for-the-Acute-Treatment-of-Migrapher.html.
  2. Satsuma Pharmaceutical has announced positive results from its ongoing STS101 ASCEND Phase 3 open-label long-term safety study. news release. Satsuma Pharmaceutical. September 30, 2022. Accessed May 19, 2023. https://investors.setsumarx.com/2022-09-20-Satsuma-Pharmaceuticals-Announces-Positive-Results-from-the-Oncoming-STS101-ASCEND-Phase-3 -Open-label, -long-term safety study.
  3. Satsuma Pharmaceutical provides STS101 development program and company updates. news release. Satsuma Pharmaceutical. December 20, 2022. Accessed May 19, 2023. https://investors.setsumarx.com/2022-12-20-Satsuma-Pharmaceuticals-Provides-STS101-Development-Program-and-Corporate-Update.



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