Teva’s Migraine Drug Fails in Phase 3 for Chronic Cluster Headaches

Xconomy National — 

Teva Pharmaceutical’s bid to add a new therapeutic application for its experimental migraine-prevention drug has faltered in a late-stage study.

Israel-based Teva (NYSE: TEVA) said Friday that it is stopping a Phase 3 clinical trial testing its drug, fremanezumab, for prevention of chronic cluster headaches. According to the company, an analysis found that the study was unlikely to meet the main goal of reducing the average number of cluster headache attacks in the 12-week treatment period. Despite the clinical trial failure, Teva noted that there were no new safety concerns with the drug.

Teva’s fremanezumab is part of a new class of drugs developed to block a protein called calcitonin gene-related peptide (CGRP), which is associated with the transmission of pain. Last month, Amgen (NASDAQ: AMGN) received the first FDA approval for a CGRP inhibitor; erenumab (Aimovig) is a once-monthly injectable drug for preventing migraines. Teva’s drug, also injectable, is  administered once every three months. In clinical studies, CGRP migraine drugs from Amgen, Teva, Eli Lilly (NYSE: LLY) and Alder BioPharmaceuticals (NASDAQ: ALDR) have reduced the average number of migraine attacks that patients experience each month.

The approach of blocking CGRP to prevent pain before it starts has companies thinking of additional applications for their respective drugs. Rarer than migraines, cluster headaches happen in cycles that typically affect one side of the head, according to the National Organization for Rare Disorders. Episodic cluster headaches are defined as one to four short headaches per day that each last 15 to 20 minutes. These headaches can occur in a span that lasts weeks to months. In chronic cluster headache, the headaches do not subside for a year or more, or have a remission period briefer than a month.

Teva had enrolled approximately 300 patients in its chronic cluster headache study, which tested both subcutaneous and intravenous versions of fremanezumab. Though that study will end, Teva said a test of its drug as a treatment for episodic cluster headache will continue as planned.

Meanwhile, an FDA decision for fremanezumab as a migraine prevention treatment is expected in September. The initial target date for a decision was June 16. But that timeline was pushed back due to problems that the FDA found earlier this year at a third-party manufacturer that makes an ingredient for the Teva drug. Teva said the new target date for a regulatory decision is Sept. 16.

Here’s more on fremanezumab and others in the new class of CGRP-blocking drugs.

Photo by Flickr user kizzzbeth via a Creative Commons license