Low-Dose DFN-11 Successful in Relieving Severe and Moderate Acute Migraine Pain

July 13, 2019

Patients with migraine who reported both moderate and severe pain intensity during headache attacks experienced high rates of relief and freedom from pain and their most bothersome symptom when treated with 3-mg sumatriptan injection, DFN-11.

Stephen Landy, MD

A 3-mg, low-dose sumatriptan injection, dubbed DFN-11, was shown to relieve both pain and the most bothersome symptom similarly in acute attacks of moderate and severe pain intensity in patients with migraine.1

Led by Stephen Landy, MD, neurologist, Baptist Medical Group, the investigators reported that in a cohort of 268 patients, DFN-11 reported significantly higher rates of pain freedom at 2 hours compared with placebo (P = .002) as well as pain relief at 2 hours (P = .018) compared to placebo. Additionally, the rates of freedom from the most bothersome symptom in post hoc analysis were also significantly higher when compared to placebo (P = .021).

The study data, which were analyzed from the RESTOR study, were presented in a poster at the 2019 American Headache Society (AHS) Annual Meeting, July 11-14, 2019, in Philadelphia, Pennsylvania.

Landy and colleagues wrote that “subjects with at least 12 months of episodic migraine (2 to 6 attacks per month on average), with no more than 14 headache days per month, and at least 48 headache-free hours between attacks, were randomized 1:1 to DFN or placebo in the double-blind period.” In total, 119 patients were randomized to placebo and 111 to DFN-11, with 104 in each treatment arm (208 total) having data post-dose.

The patients were instructed to self-administer DFN-11 to treat migraine attacks at moderate or severe pain intensity, defined as 2 or 3 on a rating scale of 0 to 3, and record real-time pain intensity and symptoms pre-dose and post-dose in an electronic diary.

The pain-freedom rates at 2 hours for the treatment arm and placebo arms, respectively, were 51% and 30.8%, while pain-relief was achieved by 76% and 61.5%, respectively. At 2 hours post-dose, 641% of the DFN-11 arm experienced freedom from their most bothersome symptom (nausea, photophobia, or phonophobia) compared to 48.1% in the placebo arm (P = .031).

Pain intensity was measured prior to the dose administration, with 78% (n = 68) of the DFN-11 group reporting moderate pain and 22% (n = 19) reporting sever pain. In the placebo group, the distribution similar between moderate and severe.

Of those in the DFN-11 group, 52.9% of the moderate pain subgroup reported pain-freedom at 2 hours while 47.4% in the severe pain subgroup achieved pain freedom. With regard to pain relief at 2 hours, this outcome was achieved by 77.9% of the moderate pain group and 68.4% of the severe pain group. As for freedom from the most bothersome system in the moderate and severe pain subgroups of the DFN cohort, freedom was achieved post dose by 62.3% and 70.6%, respectively.

“Placebo response rates at 2 hours post-dose for subjects with moderate pain pre-dose were higher vs. subjects with sever pre-dose pain intensity for all 3 measures,” Landy and colleagues detailed. “The overall therapeutic gain appears to be greater for severe [pain intensity].”

The investigators noted that the efficacy of DFN-11 has been established previously in the acute treatment of migraine in the aforementioned phase 3 study, RESTOR. In that trial, those treated with DFN-11 reported significantly higher rates of pain-freedom at 2 hours post-dose (P =  .0023), as well as higher proportions of patients who were pain-free at 30, 60, and 90 minutes post-dose (P ≤.0195). Additionally, at 2 hours post-dose, DFN-11 was also significantly superior to placebo for freedom from photophobia (P  = .0056) and phonophobia (P = .0167).2

Safety and tolerability in the RESTOR study were considered good. In total, 33.3% (37 of 111 patients) of those who received DFN-11 and 13.4% (16 of 119) of those who received placebo experienced at least 1 treatment-emergent adverse event (AE). The most common AEs for the DFN-11 group and placebo group, respectively, were injection site swelling (7.2% vs 0.8%) and pain (7.2% vs 5.9%). Chest discomfort was about half as common in the DFN-11 treatment group (0.9%) as it was in the placebo group (1.7%).

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1. Landy S, Munjal S, Brand-Schieber E, Rapoport A. The effect of migraine headache intensity on the efficacy of low-dose (3 mg) sumatriptan injection (DFN-11) in the acute treatment of episodic migraine attacks: from the RESTOR study. Presented at: 2019 American Headache Society Annual Meeting; July 11-14, 2019; Philadelphia, PA. Poster P156.

2. Landy S, Munjal S, Brand-Schieber E, Rapoport AM. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 2018;19(1):69. doi: 10.1186/s10194-018-0881-z.