Key takeaways:
- Atzumi is the primary dihydroergotamine-based nasal powder permitted for migraine remedy in adults.
- Approval was based mostly on favorable security, efficacy and tolerability knowledge from two scientific trials.
The FDA has permitted a dihydroergotamine-based nasal powder for the acute remedy of migraine with or with out aura in adults, in response to the producer.
In a press launch, Satsuma Prescribed drugs Inc. mentioned that Atzumi, previously often known as STS101, is a proprietary product that mixes a complicated nasal powder formulation of dihydroergotamine (DHE) and a novel nasal supply machine.
The FDA permitted Atzumi nasal powder for acute remedy of migraine with or with out aura in adults. Image: Adobe Inventory
“Oral DHE has poor absorption, so different formulations are necessary for delivering the treatment,” Abby Metzler, MD, affiliate professor of neurology on the College of Minnesota, informed Healio. “This new nasal powder formulation provides another choice which will assist by offering a non-invasive possibility that’s much less prone to drip down the again of the throat into the abdomen, growing absorption of the treatment.”
The FDA’s approval was based mostly on two scientific trials.
The primary was the section 3, open-label long-term security ASCEND examine through which 446 sufferers handled greater than 9,000 migraine assaults with greater than 10,500 doses of STS101 for as much as 18 months.
The second trial was a section 1 endeavor inspecting pharmacokinetics that was accomplished in June 2021. In keeping with a Satsuma press launch, administration of 5.2 mg STS101 led to “speedy and sustained achievement” of goal plasma concentrations with low pharmacokinetic variability, imply DHE plasma concentrations of two.0 ng/mL inside roughly 15 to twenty minutes, whereas additionally demonstrating a positive security and tolerability profile.
Information from these trials confirmed remedy with Atzumi resulted in speedy absorption and excessive DHE plasma concentrations, together with sustained DHE plasma ranges. The drug had a positive security and tolerability profile.
The FDA initially accepted a 505(b)(2) new drug utility for assessment for the novel therapeutic in Could 2023.
“The approval of Atzumi is a milestone to have a good time, offering a brand new possibility for the acute remedy of migraine,” Ryoichi Nagata, MD, PhD, president and CEO of Satsuma, mentioned within the launch. “We imagine that Atzumi will contribute to enhancing the standard of lifetime of sufferers struggling for aid from these extremely disabling issues.”
Reference:
TS101 (DHE Nasal Powder). https://www.satsumarx.com/our-research/sts101/. Accessed Could 2, 2025.
