Migraine

AXS-07 showed statistical significance for migraine pain freedom at 90 minutes, and at every time point after.

The oral CGRP antagonist becomes the first in its class approved for the indication.

The oral therapy showed benefit in reducing symptoms and migraine-related pain, as well as aura, within 2 hours of administration.

Drinking more than 3 servings of caffeinated beverages per day was associated with an increase in migraine headaches.

Rimegepant (rimegepant Zydis), which is a novel therapy for treatment of acute migraines, was found to reduce bothersome suymptoms and eliminate pain in a phase 3 clinical trial.

The approval is based on the findings of a 106-adult patient trial which assessed mean weekly headache episodes.

Overconfidence, anchoring errors, biases, and other factors have all led to misdiagnoses at points in my internal medicine career.

The Complete Response Letter highlights issues in the Chemistry, Manufacturing, and Controls section of the application.

While the diseases appear to be unrelated, there may be underlying factors that link them together.

An FDA decision on the application is expected by December 27, 2019.

If approved by the FDA later this year, the Allergan drug would become the first oral CGRP receptor antagonist approved for acute migraine treatment.

Galcanezumab was previously given a Breakthrough Therapy Designation for this indication.

Investigators suggest the findings mean anticoagulants or antiplatelets could potentially treat migraine patients with aura.

The FDA has approved sumatriptan nasal spray (TOSYMRA, previously known as DFN-02) for the acute treatment of migraine with or without aura in adults.

The non-invasive device is now the first and only FDA product approved for the prevention of cluster headache.

The FDA has approved Dextenza, a dexamethasone ophthalmic insert, for the treatment of ocular pain following ophthalmic surgery.

Galcanezumab will be available as a monthly 120 mg injection in pen and syringe forms for the prevention of migraine in adults.

The FDA approved the Teva Pharmaceutical drug, just months after its phase 3 program for headache clusters was discontinued.

The FDA's approval of erenumab marked a milestone in migraine treatment, and although the calcitonin gene-related peptide inhibitor class is full of promise, it has overcome many pitfalls along the way.

Despite a high level of suspicion that they triggered headache attacks from patients with migraine, a pair of studies found little to no associations between the two.

Those with chronic migraine were much more likely to see their relationships and family lives suffer due to their condition than those with episodic migraine.

In these new study results, patients administered 300 mg eptinezumab reported 8.2 fewer MMDs from baseline—when mean patient MMDs were 16.1 per month. The rate was significantly improved from that of patients administered placebo.

One year after the third and fourth quarterly infusions, those administered the 300-mg dose of eptinezumab reported reductions of 5.2 monthly migraine days, compared to 4.0 days for patients in the placebo group.

Impel NeuroPharma will study the safety and tolerability of dihydroergotamine delivered through the company’s Precision Olfactory Delivery device.

Although there were no concerns regarding the safety profile of the CGRP inhibitor, the reduction in cluster headache attacks from baseline over the 12-week treatment period was underwhelming.

The oral treatment was safe and efficacious over the course of a 12-week treatment period.

New drugs are celebrated for the lives they can improve, but it’s a long and arduous journey for those developing them and most treatments don’t make it to FDA approval.

The investigative monoclonal antibody has more data backing its efficacy, safety, and tolerability across 2 dose regimens.

CGRP inhibitor therapies have shown long-term efficacy, safety, and tolerability profiles at the clinical stages — and erenumab is just the first of them to reach the market.

The FDA has approved the first-in-class CGRP monoclonal antibody erenumab for the prevention of migraines in adults, based on findings from three clinical trials.