Teva discontinues study into headache drug

Teva Pharmaceuticals recently announced it stopped the phase 3 trial known as ENFORCE, which was examining fremanezumab for chronic cluster headaches.

The decision came after the company determined the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period was not likely to be met, according to a press release. No safety concerns were seen during the trial, the company stated.

“While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide plays a contributory role in their pathophysiology,” Tushar Shah, MD, senior vice president, head of global specialty clinical development at Teva, said in a press release.

Teva stated the episodic cluster headache study involving fremanezumab will still go on, as will attempts to have it approved by the FDA later this year as a monthly or quarterly injection for preventing migraines in adults. Fremanezumab is also being investigated as a potential treatment for post-traumatic headache disorder.

Disclosure: Shah works for Teva.