FDA Approves STS101 (Dihydroergotamine) Nasal Powder for Acute Treatment of Migraine
The only approved DHE nasal powder addresses persistent limitations of existing DHE formulations, including liquid nasal sprays and injectables, Satsuma stated.
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Satsuma Pharmaceuticals has announced the US FDA's approval of STS 101 (dihydroergotamine [DHE]) nasal powder for the acute treatment of migraine with or without aura in adults. STS101, to be marketed as Atzumi, it is the first DHE nasal powder product to be approved, according to Satsuma. The drug device product combines Satsuma's proprietary advanced DHE powder formulation with a novel nasal delivery device the company states was designed to simplify administration and improve portability.1
In clinical trials STS101 delivered rapid, high, and sustained DHE concentrations with low variability, according to Satsuma. The drug device product addresses long-standing limitations associated with existing DHE formulations, including liquid nasal sprays and injectables, the company stated.1
"The approval of [STS101] is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on [the Satsuma parent company's] novel intranasal drug delivery platform technology," Ryoichi Nagata, MD, PhD, Satsuma president and CEO, said in a statement.1
"DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of [STS101], the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages," Stewart J Tepper, MD, vice president of the New England Institute for Neurology and Headache, in Stamford, CT, added.1
ASCEND Outcomes
The FDA approval of the 505(b)(2) New Drug Application for STS101 was based on data from 2 clinical studies, a phase 1 pharmacokinetics (PK) trial and the ASCEND phase 3 open-label, long-term safety trial.2
In the ASCEND trial, DHE powder (6.2 mg DHE mesylate) STS101, delivered via a prefilled, single-use nasal device was evaluated over 18 months. The 344 participants had a mean age of 40 years and reported migraine with or without aura expressed as 4 to 12 monthly migraine attacks, and fewer than 15 headache days per month in the 3 months preceding screening. Participants self-administered DHE powder as needed for migraine attacks, with a maximum of 2 doses within 24 hours and up to 12 doses per month.2
Among the 47.4% reported migraine with aura and 31.7% reported allodynia. Across a reported 6610 migraine attacks, approximately 19.9% required a second dose. The most common treatment-emergent adverse events (TEAEs) were nasal discomfort (11.3%), dysgeusia (7.6%), nasal congestion (5.2%), nasopharyngitis (5.2%), and nausea (4.9%), with the majority being mild or moderate. Severe TEAEs occurred in only 2.6% of participants. A total of 25.9% of participants experienced a TEAE considered related to study treatment, and the rate of severe TEAEs was 0.2% per treated attack.2
Adapted from Tepper S et al. CNS Drugs. 2024;38(12):1017–1027.
The safety profile of STS101 was comparable to that of the previously available dihydroergotamine 1.45 mg liquid nasal spray, which had reported rhinitis (26%), nausea (10%), vomiting (4%), dysgeusia (8%), application site reaction (6%), and dizziness (4%) as common adverse events. No new safety signals related to the novel powder formulation or delivery route were identified.2
According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the leading cause of disability among neurologic disorders in the US. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women.3 "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems," Nagata stated.1
