Dihydroergotamine nasal powder provides sustained pain relief in migraine patients

AUSTIN, Texas — Sustained freedom from pain and the most bothersome migraine symptom was achieved in more patients treated with investigational STS 101 compared with placebo, according to a study presented here.

“STS101, or dihydroergotamine nasal powder, is a drug-device combination,” Alan Rapoport, MD, professor of neurology at David Geffen School of Medicine at the University of California, Los Angeles, said. “This is a simple, small, nasal-delivery device that does not have to be set up in any way... and it contains a mucoadhesive drug carrier with engineered particle technologies to facilitate rapid and sustained DHE absorption.”

To evaluate the efficacy of STS101 (dihydroergotamine [DHE] nasal powder, Satsuma Pharmaceuticals) for the acute treatment of migraine, Rapoport and colleagues conducted the randomized, double-blind, placebo-controlled SUMMIT study and included adult patients with two to eight moderate or severe migraine attacks and fewer than 15 headache days per month.

Each participant received a single dose of 5.2 mg STS101 (n = 716; mean age, 38.2 years; 21% men) or placebo (n = 708; mean age, 38.9 years; 20% men) and were asked to record migraine data in an electronic diary for up to 48 hours after dosing.

Efficacy endpoints included sustained freedom from pain, sustained freedom from the most bothersome symptom and sustained pain relief.

In patients who used STS101, sustained pain freedom was recorded in 15.8% at 2 to 24 hours compared with 12.1% of those who received placebo, a difference of 3.7% (P < .5). At 3 to 24 hours and 4 to 24 hours, the difference was 7.8% (P < .001) and 9.8% (P < .0001).

For sustained freedom from the most bothersome symptom, the difference between treatment and placebo was 7.4% (P < .01), 9.9% (P < .0001) and 15% (P < .0001), respectively.

Additionally, the differences between the two groups for sustained pain relief were 10.3%, 14% and 14.3% for the three time periods (P < .0001 for all).

Rescue medications were used in 21.8% of participants in the STS101 group in 24 hours vs. 33.3% in the placebo group, a statistically significant difference of 11.5%. In 48 hours, that use increased to 31.3% in the STS101 group and 41.2% in the placebo group, a difference of 9.9%.

“STS101 DHE nasal powder was significantly more effective in providing sustained efficacy, which is freedom from pain and the most bothersome symptom, starting at 2 hours and on, as well as pain relief with lower use of rescue medication,” Rapoport said.