Teva discontinues the ENFORCE trial of fremanezumab for chronic cluster headache but the episodic cluster headache part of the study continues as planned.

Teva Pharmaceutical Industries Ltd. announced a change in the clinical development program of fremanezumab in chronic cluster headache . The ENFORCE Phase III clinical development program 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. There were no safety concerns observed with fremanezumab treatment in the trial.

Based on the study meeting the futility criteria, the Company will discontinue the trial for chronic cluster headache. Chronic Cluster Headache patients who participate in the long-term safety study, will discontinue their participation in the long-term safety study as well. The episodic cluster headache study is not affected and continues as planned.

Comment: Fremanezumab is currently under review by the FDA, with an action date of 16 September 2018, and by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.