The study concludes that DFN-11 was safe, effective, and tolerable in the acute treatment of 4 migraine attacks over eight weeks, with consistent responses on pain and associated symptoms. 

A migraine is a painful, debilitating, lifelong disease. Acute migraine medications are rated as effective with consistent relief and fewer side effects among migraineurs. Clinical trial guidelines also recommend assessment of the consistency of response to acute medications in multiple attacks, but the effectiveness of acute medicines has not been adequately evaluated. The utility of acute treatment depends on their ability to be useful for long-term; however, inconsistent relief is an essential reason for dissatisfaction with acute therapy. Moreover, adherence to acute treatment is dependent on the confidence that an intervention will reliably relieve migraine pain and associated symptoms. There is a lack of single-attack studies to evaluate inter-attack variability of treatment outcomes.

DFN-11 is a low dose SC sumatriptan injection (3mg), supplied as a single-dose, ready-to-use, disposable autoinjector. DFN-11 has less sumatriptan as compared with the 6-mg SC dose of sumatriptan per 0.5-mL dose (3 mg vs 6 mg). Another research has elucidated that DFN-11 provides more significant pain relief and associated symptoms similar to a 6-mg SC dose of sumatriptan, with a lower incidence of triptan sensations and no reports of chest pain, in patients with rapidly-escalating migraine attacks. DFN-11 was more effective than placebo on pain-free and pain relief outcomes from 30 min through 2 h postdose with a lower incidence of TEAEs and triptan sensations in episodic migraine.

Rationale behind the research:

Acute migraine medications have been rated as effective in migraine patients, but the efficacy and safety have not been fully elucidated. The present study was intervened to determine the effectiveness of intravenous sumatriptan in the acute treatment of multiple migraine attacks.

Objective:

The purpose of the present open-label extension study was to determine the efficacy, safety and tolerability of DFN-11 in the acute treatment of multiple attacks in adults with episodic migraine.

Study outcomes:

• Patient demographic characteristics were evaluated at baseline
• Other outcomes include evaluation of efficacy endpoints such as percentage of subjects who had pain relief, pain-freedom, and absence of most bothersome symptom (MBS) at a time interval of 10, 15, 20, 30, 60, 90, and 120 min, and the subjects who were free from nausea, photophobia, and phonophobia at 2 h postdose and safety endpoints such as the percentage of subjects with severe AEs (SAEs) and changes in vital signs or ECGs

Time Points: 2-24 hrs.

Outcomes:

Baseline: There were no significant differences observed at baseline

Study outcomes:

• There was a substantial improvement in migraine pain freedom, pain relief, and associated symptoms with DFN-11 at two h postdose with a narrow range across attacks. {Fig 2.}

• There was an incidence of treatment-emergent adverse events (TEAE) in 40.6% (89/219) of subjects, the most common of which were: swelling (12.8%), pain (11.4%), irritation (6.4%), and bruising (6.4%) {Fig 3.}

• The incidence of mild TEAEs were reported in most subjects (65.2%, 58/89) and severe TEAEs were published by one subject (treatment-related jaw tightness)

• There were no severe TEAEs and no new or unexpected safety findings

The findings of the study indicated that DFN-11 was effective, tolerable, and safe in the acute treatment of multiple migraine attacks over eight weeks. The magnitude of varied attack response to DFN-11 was roughly comparable to the 6 mg SC dose of sumatriptan as published in the previous reports. For example, an 18-month open-label study of 6 mg SC dose reported 2h response rates of 72% and 62% for pain relief and pain-free. Another trial evaluating SC 6 mg across 455 attacks in 100 consecutive patients reported approximately 84% of subjects with pain relief at two h post dose. In the current study the effects of DFN-11 across four attacks, the range of 2h pain relief was narrow and lower (approximately 58–66%), but the pain relief responses were considerably higher (about 82–88%). Also, there was a low incidence of TEAEs that decreased across the four attacks can help in increasing patient confidence in positive results, encourage patient adherence to professional recommendations contributing to better efficacy outcomes in clinical practice.