You are here

New Episodic Cluster-Headache Treatment Cuts Attack Frequency

Patients Had 8+ Fewer Weekly Attacks

The FDA has approved galcanezumab-gnlm injection solution (Emgality, Eli Lilly) for the treatment of episodic cluster headache in adults. It is the first FDA-approved drug to reduce the frequency of attacks of episodic cluster headache, which can be extremely painful as well as debilitating.

Cluster headaches often occur at the same time of day, for several weeks to months. Symptoms can include bloodshot eyes, excessive tearing of eyes, drooping of eyelids, runny nose and/or nasal congestion, facial sweating, restlessness, and agitation. Attacks can strike several times a day, and typically last from 15 minutes up to three hours. 

The effectiveness of galcanezumab-gnlm was demonstrated in a trial comparing the drug to placebo in 106 patients. The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the groups. Patients taking galcanezumab-gnlm experienced 8.7 fewer weekly attacks than they did at baseline, compared to 5.2 fewer attacks for patients taking placebo. 

Using galcanezumab-gnlm carries a risk of hypersensitivity reactions, and treatment should be discontinued if reaction occurs. Hypersensitivity reactions can occur days after administration and can be prolonged. The most common side effect reported by trial participants was injection-site reactions.

Galcanezumab-gnlm injection is self-administered. It was previously approved by the FDA in September 2018 for the preventive treatment of migraine in adults.

The FDA granted this application priority review and breakthrough designations.

Source: PR Newswire, June 4, 2019

Recent Headlines

Over Half of Patients Had Reduced Pain Levels of 30% or More
Spina Bifida, Cleft Lip Among Defects Caused by Antiepilectics
Study Data Indicate Drug May Provide Complete Remission in PV
Teplizumab Slows Progression to Disease by at Least Two 2 Years
Over 25% of Study Patients Showed 6–12 Months Remission
Researchers Extend Previous Data, Find Association is Reversed
First Anti-PD-1 Therapy Demonstrates Improved Overall Survival
New Test Could Prevent Short- and Long-term Complications
Nivolumab/Chemotherapy Arm Shows No Unexpected Toxicities