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In clinical trials, the dihydroergotamine (DHE) nasal powder had favorable safety profiles and rapid pain relief in patients with migraine with or without aura.
The FDA approved dihydroergotamine (DHE, formerly STS101; Atzumi; Satsuma Pharmaceuticals), a nasal powder indicated for the acute treatment of migraine with or without aura in adult patients. This approval is supported by findings from a phase 1 pharmacokinetics trial (NCT03874832) and the phase 3 ASCEND trial (NCT04406649).1
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Migraines are a neurological disorder that is believed to be the result of temporary changes in the chemicals, nerves, and blood vessels within the brain. Mayo Clinic reports that migraines can progress through 4 stages—prodrome, aura, attack, and post-drome—and symptoms are often incapacitating. According to the American Migraine Foundation, there are an estimated 40 million Americans who live with migraine. They report that it is the second leading cause of disability worldwide (defined by time lost to disability) and the most common cause of disability among young women.1,2
Since an initial approval in 1946, DHE has been widely recommended in published guidelines as a first-line treatment option for migraine, with notable advantages compared with other antimigraine treatments. Its previous disadvantages consisted of its liquid nasal spray and injectable formulations, which were considered to be burdensome and invasive. Additionally, its “suboptimal” clinical performance had hindered its widespread use, according to a news release from Satsuma Pharmaceuticals. This new formulation, Atzumi, is an easy-to-use, carriable device, making it more accessible and efficient for patient use.1
"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," said Ryoichi Nagata, MD, PhD, FFPM, president and CEO of Satsuma, in a news release. "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems."1
ASCEND
The 2-part, active-controlled, 3-period crossover phase 1 trial (NCT03874832)3 investigated and compared the safety and pharmacokinetics of DHE intranasal spray (Migranal; Sterimaxinc) and Atzumi. In the enrolled population, Atzumi demonstrated rapid absorption and achieved the effective DHE plasma concentrations within 10 minutes of administration. Additionally, compared with Migranal, it achieved a higher maximum serum concentration, area under the curve (AUC) from 0 to 2 hours, and AUC from administration to when the drug is no longer in the body. It also demonstrated a favorable tolerability profile.3,4
Further, in the multi-center, multiple-dose, open-label, 12-month phase 3 trial, ASCEND (NCT04406649)5, the long-term, as-needed use of Atzumi was well tolerated and demonstrated a meaningful safety profile when used as an acute treatment of migraine attacks, with or without aura, in adults aged 18 to 65 years. Of the 6610 migraine attacks treated with a total of 8234 doses in 334 patients, only 14.3% (n = 945) were associated with a treatment-emergent adverse event. These were considered mild or moderate in nature, with few (n = 15; 4.4%) leading to study discontinuation.5,6
The patients treated with Atzumi reported a rapid onset of freedom from pain (36.6%, 67.1%, and 85.5% of treated attacks 2-, 4-, and 24-hours post-administration, respectively), freedom from most bothersome symptoms (54.3%, 79.6%, and 91.3%), and headache relief (66.5%, 89.1%, and 94.3%). Additionally, most participants rated treatment results as “good” or “very good” and ease of use as either “easy” or “very easy” during months 3, 6, and 12.5,6
"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, MD, vice president of the New England Institute for Neurology and Headache in Stamford, Connecticut, said in the news release.1
