Teva announced that the ENFORCE phase 3 clinical development program for fremanezumab in the treatment of cluster headaches will be discontinued following results from a pre-specified futility analysis which revealed that the episodic cluster headache study was unlikely to meet the primary endpoint (mean change from baseline in weekly average number of cluster headaches during the 4-week treatment period).
The clinical development program also included a study involving patients with chronic cluster headache which was discontinued in June 2018. An analysis of the data showed the study was unlikely to meet the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period.
“Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology,” said Tushar Shah, MD, Senior Vice President, Head of Global Specialty Clinical Development at Teva. The Company is currently evaluating fremanezumab as a potential treatment for patients with posttraumatic headache.
Fremanezumab, a calcitonin gene-related peptide (CGRP) antagonist, is currently approved by the Food and Drug Administration (FDA) for the preventive treatment of migraine in adults under the brand name Ajovy.
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