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Key clinical point: Dihydroergotamine (DHE) nasal powder was well tolerated over the long term for the acute treatment of migraine.
Major findings: Treatment-emergent adverse events were reported in 48.5% of the participants, with nasal discomfort being the most common (11.3%). No deaths were reported. A serious adverse event related to treatment occurred in only one participant who did not disclose contraindications to DHE, and 4.4% of the participants discontinued the use of DHE. There were no new safety concerns.
Study details: The ASCEND trial involved 344 adults aged 18-65 years with a history of 4-12 migraine attacks per month for at least 1 year. Participants self-administered DHE (5.2 mg) as needed, with a maximum of 12 doses per month, for 1 year.
Disclosure: This study was funded by Satsuma Pharmaceuticals, Inc. Two authors declared being employees and stockholders of Satsuma, and others declared having ties with various sources, including Satsuma.
Sources: Tepper SJ, Albrecht D, Ailani J. Kirby L, Strom S, Rapoport AM. Long-term (12-Month) safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine: Data from the phase 3 open-label ASCEND study. CNS Drugs. Published online October 7, 2024. Source
Key clinical point: Dihydroergotamine (DHE) nasal powder was well tolerated over the long term for the acute treatment of migraine.
Major findings: Treatment-emergent adverse events were reported in 48.5% of the participants, with nasal discomfort being the most common (11.3%). No deaths were reported. A serious adverse event related to treatment occurred in only one participant who did not disclose contraindications to DHE, and 4.4% of the participants discontinued the use of DHE. There were no new safety concerns.
Study details: The ASCEND trial involved 344 adults aged 18-65 years with a history of 4-12 migraine attacks per month for at least 1 year. Participants self-administered DHE (5.2 mg) as needed, with a maximum of 12 doses per month, for 1 year.
Disclosure: This study was funded by Satsuma Pharmaceuticals, Inc. Two authors declared being employees and stockholders of Satsuma, and others declared having ties with various sources, including Satsuma.
Sources: Tepper SJ, Albrecht D, Ailani J. Kirby L, Strom S, Rapoport AM. Long-term (12-Month) safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine: Data from the phase 3 open-label ASCEND study. CNS Drugs. Published online October 7, 2024. Source
Key clinical point: Dihydroergotamine (DHE) nasal powder was well tolerated over the long term for the acute treatment of migraine.
Major findings: Treatment-emergent adverse events were reported in 48.5% of the participants, with nasal discomfort being the most common (11.3%). No deaths were reported. A serious adverse event related to treatment occurred in only one participant who did not disclose contraindications to DHE, and 4.4% of the participants discontinued the use of DHE. There were no new safety concerns.
Study details: The ASCEND trial involved 344 adults aged 18-65 years with a history of 4-12 migraine attacks per month for at least 1 year. Participants self-administered DHE (5.2 mg) as needed, with a maximum of 12 doses per month, for 1 year.
Disclosure: This study was funded by Satsuma Pharmaceuticals, Inc. Two authors declared being employees and stockholders of Satsuma, and others declared having ties with various sources, including Satsuma.
Sources: Tepper SJ, Albrecht D, Ailani J. Kirby L, Strom S, Rapoport AM. Long-term (12-Month) safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine: Data from the phase 3 open-label ASCEND study. CNS Drugs. Published online October 7, 2024. Source