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CGRP Studies Continue to Show Promise

Two new studies—focusing on different approaches for targeting CGRP in migraine—were presented at the American Headache Society 58th Annual Scientific Meeting.

The new class of drugs currently under development have been causing excitement because of their effectiveness in treating chronic migraine. These agents reduce the levels of a protein known as calcitonin gene-related peptide (CGRP), which plays a role in the initiation, transmission, and sensitivity to migraine pain.

The new drugs, anti-CGRP antibodies, bind to the protein and stop it from attaching to nerve receptions, preventing migraine in the process. The two approaches for targeting CGRP are monoclonal antibodies given by injection and an oral agent for acute treatment.

Both approaches were presented at the meeting in June 2016. In one study, researchers investigated a single intravenous dose of 100 or 300 mg ALD403, a monoclonal antibody targeted to CGRP.

Alder BioPharmaceuitcals Inc., the company developing the product, reported that 33% of patients given a 300-mg single intravenous dose of ALD403 and 31% of patients given a 100-mg dose had a 75% reduction in migraine days per month. This compares with 21% of patients receiving a placebo.

The second study investigated ubrogepant, an oral CGRP receptor blocker. In the analysis of this study, 640 patients were randomly assigned to one of five doses of ubroagent (1, 10, 25, 50, or 100 mg) or placebo. The focus of the study was pain freedom and headache response at 2 hours.

This study revealed that 25.8% of patients receiving the 100-mg dose achieved 2-hour pain freedom compared to 8.9% of patients who were given the placebo.

Richard Lipton, MD, professor and vice chair of neurology at Albert Einstein College of Medicine and director of the Montefiore Headache Center in New York City was the lead author of this study.

“The initial trials offer positive adverse expectations for further trials with the 2 products, an intravenous administration, for prevention and an oral compound, ubrogepant, for acute attacks,” said NHF Board Member, Dr. Arthur Elkind.

“As a clinical investigator involved with numerous previous trials, I must caution that extensive trials will be necessary with the compounds to demonstrate significant effectiveness, and of utmost importance, treatment safety. At times it is only after long term and large population studies that significant adverse events are detected. The CGRP target has been known for several years and hopefully will offer further therapeutic options for migraine patients.”

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