Migraine

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.

A massive genetic family migraine patient study found more defined risk scores for migraine subtypes.

Patients who had previously failed ≥2 preventative migraine treatments were effectively treated with galcanezumab, especially when compared to placebo.

Results from Alder Biopharmaceutical’s phase 3 study demonstrated reductions in migraine following quarterly infusions of both 100 mg and 300 mg eptinezumab versus placebo in patients with episodic migraines.

Trial results on the recently FDA-approved gammaCore device will be presented at the American Academy of Neurology (AAN) annual meeting.

Study results show 30.3% of difficult to treat patients taking erenumab saw at least a 50% reduction in monthly migraine days.

Migraine was associated with a higher incidence of myocardial infarction, and ischaemic and haemorrhagic stroke.

The 50-mg dose showed that 19.2% of patients were free of pain after 2 hours while the 100-mg dose resulted in 21.2% of pain-free patients.

Migraine patients have been found to suffer more than nearly all other chronic pain patients but can be relieved by surgery.

The Alder Pharmaceuticals product showed an average reduction of 8.2 monthly headache days.

Relive the 10 biggest headlines in this year of clinical news.

Data from 3 phase 3 studies demonstrates a significant decrease in the average number of monthly migraine headache days.

Sodium concentrations were significantly higher in the brain’s cerebrospinal fluid in migraine patients.

Eptinezumab, a monoclonal antibody, has shown impressive results in previous clinical trials, giving high hopes for the PROMISE 2 trial.

The monoclonal antibody reportedly reduced headache days by 4.3 and 4.6 days for the 625 mg and 225 mg doses, respectively.

The FDA has set a Prescription Drug User Fee Act target date for May 17, 2018.

The thin-film formulation of rizatriptan is an orally administered, 10 mg soluble tablet for acute migraine.