A low dose of sumatriptan provided significantly higher 2-hour pain freedom and 2-hour pain relief vs. placebo, according to phase 3 trial findings presented at PainWeek.
“The efficacy of a low dose sumatriptan injection (3 mg) in the acute treatment of migraine has not been previously assessed in a large, placebo-controlled study,” Stephen Landy, MD, of Baptist Medical Group in Memphis, Tennessee, and colleagues wrote.
Researchers looked at 208 adult patients with episodic migraine with or without aura who were randomly assigned in a 1:1 ratio to self-administer either a 3-mg dose of sumatriptan or placebo and then record their real-time pain experiences.
Landy and colleagues found that those 51% of the patients who received the sumatriptan had 2 hours of pain freedom compared with 30.8% of those who received placebo. In addition, 76% of those who received sumatriptan had 2 hours of pain relief, compared with 61.5% of those who received placebo.
Researchers also reported injection site pain and swelling were the most common adverse events due to treatment, but only seven patients discontinued the study as a result of these adverse events. Also, more of those who received the treatment were free from their “most bothersome symptom” — whether it be phonophobia, photophobia or nausea — compared with those who received placebo.
Sumatriptan also showed consistent efficacy across four migraine attacks in an 8-week open label study phase in this same group of patients, Landy and colleagues wrote.
In a different study, these same researchers looked at adverse events in 230 patients with episodic migraine randomly assigned in a 1:1 ratio to receive a 3-mg dose of sumatriptan or placebo and compared their adverse events with those who received 6 mg of sumatriptan.
“Despite the established efficacy of subcutaneous sumatriptan 6 mg, fewer than 10% of migraine sufferers use it. Among the reasons for this are triptan sensations and the high incidence of injection site reactions,” Sagar Munjal, MD, MS, and vice president and chief medical officer of Promius Pharma, and colleagues wrote.
Researchers found there was a low incidence of adverse events in the patients studied, suggesting that the 3-mg dose of sumatriptan may be an alternative to the 6-mg dose. – by Janel Miller
Landy S, et al. Low-dose (3 mg) sumatriptan injection (DFN-11) efficacy, tolerability, and safety in episodic migraine: RESTOR, a randomized, double-blind, placebo-controlled study.
Landy S, et al. Efficacy, tolerability, and safety of repeat dosing with DFN-11, a low-dose (3 mg) sumatriptan injection, in episodic migraine: an open-label extension of RESTOR.
Munjar S, et al. Tolerability of DFN-11, low dose (3 mg) sumatriptan injection: Focus on triptan sensations and injection site reactions in the RESTOR episodic migraine study.
All presented at: PainWeek 2018; Sept. 4-8; Las Vegas.
Munjal is an employee of Promius Pharma. Healio Family Medicine was unable to determine relevant financial disclosures for other authors prior to publication.