Migraine And Headache
A total of 1,327 migraine patients were treated in the study for a single migraine attack. At 2 hours after migraine attack, 19.2% (n=423) and 21.2% (n=448) of ubrogepant 50mg and 100mg were pain free, respectively.
There were positive associations for migraine with myocardial infarction, ischemic stroke and hemorrhagic stroke, venous thromboembolism, and atrial fibrillation or flutter.
The new approval for migraine patients was supported by the PRESTO trial, a multicenter, randomized, double-blind, sham-controlled trial.
Aimovig is a fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor.
The 'PROMISE 2' study included 1,072 patients who were randomized to receive eptinezumab (300mg or 100mg), or placebo once every 12 weeks.
Results from the CM trial found that the fremanezumab arm experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo.
The new and revised standards from The Joint Commission were published in July 2017 to address some of the issues associated with over-prescribing and lack of monitoring.
Migraine days were cut by ≥50% for half of the 140mg group, by 43.3% for the 70mg group, and by 26.6% for the placebo group.
The Food and Drug Administration (FDA) approval was based on several studies that demonstrated 1 hour of use with Cefaly Acute could relieve or stop the migraine headache.
The mean length of ketamine infusion was 5.1 days, with the lowest pain rating on day 4, which was achieved at mean ketamine rates of 30.8±3.6 mg/hr less than the maximum dose.
Zecuity, launched in September 2015, is a transdermal system that delivers a therapeutic dose via a single-use, battery-powered patch wrapped around the upper arm or thigh.
Participants were randomized to either hydromorphone 1mg (n=64) or prochlorperazine 10mg plus diphenhydramine 25mg (n=62).
The studies looked at the safety, tolerability, and efficacy of 4 dose regimens of subcutaneous fremanezumab vs. placebo over 16 weeks.
With regards to treatment, all of the patients responded to CSF pressure-/volume-lowering therapies (ie, acetazolamide or spironolactone).
Results demonstrated that at 12 weeks after the first dose of fremanezumab, the CM group had reductions of monthly headaches; -4.6 days for the monthly dose, -4.3 days for the quarterly dose and -2.5 for the placebo group (P<0.0001).
The study concluded that the cost of medical grade oxygen for the acute treatment of CH is not prohibitively expensive for patients or for insurance providers.
Results showed that at the end of the 12-week trial participants in the Aimovig 140mg group had a reduction of 7 MMDs and the 70mg group had a reduction of 5.4 days, while the placebo group had a reduction of 2.7 days (P<0.001).
The non-invasive SpringTMS device is placed at the back of the patient's head where a forced magnetic pulse is delivered to treat an acute attack or to prevent a future migraine onset.
For abortive medications, results showed that overall 18.9% of patients received all high quality abortive medication, 27% received some low quality abortive while 15.2% received opioids.
Results showed that a statistically significant number of those participants who received lasmiditan (in all doses) were pain-free at 2-hours post dosage compared to those who received placebo (the primary endpoint).
The Stimpod NMS460 includes a nerve-mapping pen-like probe which allows practitioners to locate nerves and evaluate the treatment progress.
The use of complementary and alternative medicine (CAM) specifically for the treatment of migraine and headache is "relatively low" in the U.S.
Its agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
If approved by the FDA, Aimovig will be the first monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor specifically intended for migraine prophylaxis.