A pre-specified futility analysis of a Phase III study in episodic cluster headache revealed that the study's primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the four-week treatment period is unlikely to be met.
As a result of the above, Teva is discontinuing the ENFORCE Phase III clinical trial program, which also includes a long-term safety study.
The programme previously included a chronic cluster headache study, which was discontinued in June of 2018.
Teva continues to explore other uses for fremanezumab, including the treatment of post-traumatic headache (currently being studied in a Phase II trial).
Fremanezumab is a humanised monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor. Fremanezumab is considered an investigational compound in the treatment of cluster headache or post-traumatic headache and is not approved by any regulatory agency for those uses.
Teva Pharmaceutical Industries is in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area.
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
EQT agrees to acquire majority stake in Adalvo
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment
Avera joins Civica to help maintain drug supplies
Apotex launches generic version of Tasigna in US market
CivicaScript launches droxidopa for symptomatic neurogenic orthostatic hypotension
Padagis' Naloxone HCl Nasal Spray 4 mg obtains extended shelf-life of 36 months
ANI Pharmaceuticals announces US launch of Nitazoxanide Tablets