FDA approves Atzumi for acute migraine treatment in adults

Key takeaways:

• Atzumi is the first dihydroergotamine-based nasal powder approved for migraine treatment in adults.
• Approval was based on favorable safety, efficacy and tolerability data from two clinical trials.

The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in adults, according to the manufacturer.

In a press release, Satsuma Pharmaceuticals Inc. said that Atzumi, formerly known as STS101, is a proprietary product that combines an advanced nasal powder formulation of dihydroergotamine (DHE) and a novel nasal delivery device.

“Oral DHE has poor absorption, so other formulations are important for delivering the medication,” Abby Metzler, MD, associate professor of neurology at the University of Minnesota, told Healio. “This new nasal powder formulation adds another option that may help by providing a non-invasive option that is less likely to drip down the back of the throat into the stomach, increasing absorption of the medication.”

The FDA’s approval was based on two clinical trials.

The first was the phase 3, open-label long-term safety ASCEND study in which 446 patients treated more than 9,000 migraine attacks with more than 10,500 doses of STS101 for up to 18 months.

The second trial was a phase 1 endeavor examining pharmacokinetics that was completed in June 2021. According to a Satsuma press release, administration of 5.2 mg STS101 led to “rapid and sustained achievement” of target plasma concentrations with low pharmacokinetic variability, mean DHE plasma concentrations of 2.0 ng/mL within approximately 15 to 20 minutes, while also demonstrating a favorable safety and tolerability profile.

Data from these trials showed treatment with Atzumi resulted in rapid absorption and high DHE plasma concentrations, along with sustained DHE plasma levels. The drug had a favorable safety and tolerability profile.

The FDA originally accepted a 505(b)(2) new drug application for review for the novel therapeutic in May 2023.

“The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine,” Ryoichi Nagata, MD, PhD, president and CEO of Satsuma, said in the release. “We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.”

Reference:

TS101 (DHE Nasal Powder). https://www.satsumarx.com/our-research/sts101/. Accessed May 2, 2025.