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FDA Approves STS101 Nasal Powder as New Treatment for Acute Migraine
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Key Takeaways
- STS101, a dihydroergotamine nasal powder, is FDA-approved for acute migraine treatment, offering rapid onset and flexible dosing.
- The nasal delivery system ensures faster action compared to oral treatments, crucial for quick migraine relief.
Satsuma’s STS101 nasal powder becomes the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults.
Ryoichi Nagata, MD, PhD, FFPM
(Credit: Satsuma)
According to an announcement, the FDA has granted approval to Satsuma’s dihydroergotamine (DHE) nasal powder agent, STS101, marketed as Atzumi, as a new treatment for patients with acute migraine with or without aura.1
The company noted that the nasal powder is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. In addition, the most common adverse events (AEs) reported with the agent were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
STS101 is delivered through a specialized, optimized device, otherwise known as the STS101 delivery device, which ensures consistent and accurate dosing. Per the medication’s label, patients can self-administer up to 2 doses of STS101 (5.2 mg per dose) within 24 hours, offering flexibility based on the severity of their migraine attacks. The nasal delivery, seen as an advantage over oral treatments, ensures faster onset of action, which is critical for treating migraines quickly.
"The approval of Atzumi 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 SNBL's novel intranasal drug delivery platform technology," Ryoichi Nagata, MD, PhD, FFPM, president and CEO at Satsuma, said in a statement.1 "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems."
With the approval, it becomes the third drug marketed this year for the treatment of migraine, following the approvals of AXS-07 (Symbravo; Axsome Therapeutics) and CT-132 (Click Therapeutics). STS101 is considered a DHE treatment, which have been used to treat various forms of vascular headaches, including migraines, for years. DHE works by acting on serotonin (5-HT0 receptors in the brain, particularly 5-HT1B and 5-HT1D receptors. This class of medications are still commonly used to treat acute migraines, especially when triptans are ineffective, contraindicated, or are not tolerated.
STS101’s original new drug application (NDA) submission, accepted for review in May 2023, was met with a complete response letter (CRL) by the FDA.2 At the time, the agency raised no concerns with the clinical trial results presented; however, the agency did provide comments related to the formulation of the drug and its manufacturing. After several months, which included a Type A meeting with the FDA, Satsuma resubmitted the NDA, believing that it addressed all outcomes in the CRL.3
The original submission was based on findings from the phase 1 comparative pharmacokinetic and safety trial (NCT03874832) and the phase 3 ASCEND trial (NCT04406649). Although not required for the application, the results from the phase 3 SUMMIT trial (NCT04406649) were also considered. In SUMMIT, STS101 demonstrated a numerical, but not statistically significant difference vs placebo on the coprimary end points of freedom of pain and freedom from the most bothersome symptom (MBS) at 2 hours post dose.
"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 Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages", Stewart J. Tepper, M.D., vice president of the New England Institute for Neurology and Headache, said in a statement.1
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The ASCEND trial was a multicenter, open-label safety study involving 480 participants. Of these, 466 individuals self-administered at least one dose of STS101 or STS101Mk1 (the latter using a first-generation delivery device), with the study medication transitioning from STS101Mk1 to STS101 in early 2021. The trial found no significant safety or tolerability issues with the nasal or systemic use of STS101 (n = 344). Only 4.1% of participants discontinued because of AEs, and no unexpected serious treatment-related AEs were reported.4
Among 172 participants treated exclusively with STS101, 34.2% achieved freedom from pain within 2 hours of treatment, and 53.4% achieved freedom from most bothersome symptom (MBS) at the same time point. Additionally, over 81% of participants did not require a second dose within 48 hours of the initial dose. Patients could administer up to two 5.2 mg doses in 24 hours, with a maximum of 12 doses per month over the course of a year, and were restricted to two or fewer additional migraine treatments. The average age of participants was 39 years, with 89% being women and 84% being Caucasian.
During the study, 7.3% of participants (n = 20) discontinued treatment due to AEs, with 2.9% (n = 8) reporting nasal AEs. The most commonly reported AEs were nasal discomfort (13.9%), dysgeusia (7.7%), and nasal congestion (6.2%). Serious AEs, such as postural orthostatic tachycardia syndrome and cholecystitis, occurred in one individual each but were not considered related to the treatment. The introduction of the optimized STS101 device midway through the trial did not affect AE rates or severity.
