Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Shots:The US FDA has approved 505(b)(2) NDA of Atzumi (STS101) nasal powder for the acute treatment of migraine with or without aura in adultsApproval was based on a P-I PK trial & P-III (ASCEND) trial, both showing fast absorption, rapid high DHE levels, & sustained DHE plasma concentrations over timeAtzumi utilizes SMART…

ByRidhi RastogiMay 1, 2025

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Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots:The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 2025

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Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Shots: Marija Geertsen shares the highlights of the data presented at the 65th AHS annual meeting, including insights from real-world experience with VYEPTI's review study With a focus on the review study that delved into the experiences of 94 patients receiving VYEPTI treatment, Marija provides an in-depth account of the PROMISE 1 and PROMISE 2…

BySaurabh ChaubeyNovember 6, 2023

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Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots:Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTIShe also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening…

BySenior EditorAugust 14, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health careThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…

BySenior EditorMarch 27, 2020

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Insights+: The US FDA New Drug Approvals in February 2020

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Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Insights+: The US FDA New Drug Approvals in February 2020

FOLLW US

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