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Teva Changes Course in Headache Care

June 19, 2018
Company ceases chronic cluster headache indication, continues pursuit of episodic cluster and migraine treatment

A PPM Brief 

Teva Pharmaceutical Industries (North Wales, PA) announced earlier this week a major change in the clinical development program of its monoclonal antibody, fremanezumab, being studied for the prevention of migraine and certain types of chronic headache.

The company’s Phase III development program, ENFORCE, includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study.  “A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met,” said Teva representatives in a company release. Although there were no safety concerns observed, based on these results, Teva said in its release that it will “discontinue the trial for chronic cluster headache.”

Those patients with chronic cluster headache will discontinue their participation in the long-term safety study as well, according to the company release. The episodic cluster headache study, however, will continue as planned.

Fremanezumab is also currently under review by the FDA and the EMA as a quarterly or monthly injection for the prevention of migraine in adults. In Practical Pain Management’s June cover story on CGRPs, Joshua M. Cohen, MD, MPH, FAHS, Teva’s Global Therapeutic Area Lead Migraine & Headache, shared the company’s HALO trial results to date for this indication.


Last updated on: June 16, 2020
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