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A migraine is a painful, debilitating, lifelong disease.
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:
Time Points: 2-24 hrs.
Outcomes:
Baseline: There were no
significant differences observed at baseline
Study outcomes:
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.
The study results established that DFN-11 was consistently
effective, tolerable, and safe in the multiple migraine attacks over eight
weekend these findings may help clinicians in the management of acute treatment
of migraine.
The Journal of Headache and Pain (2018) 19:70
Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study
Landy et al.
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