Data from Pharmawand - Curated by EPG Health - Date added 16 May 2018

Teva Pharmaceutical announced the publication of data from the Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly (every three months) and monthly subcutaneous dosing regimens of TEV 48125 (fremanezumab) for the prevention of episodic migraine (EM). These pivotal data were published online by The Journal of the American Medical Association (JAMA).

The study evaluated the use of both quarterly and monthly dosing regimens of subcutaneous fremanezumab, compared with placebo in patients with EM (defined as 14 migraine headache days or less per month) who had previously failed multiple medication classes. The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens. The baseline mean number of monthly migraine days was 8.9, 9.2, and 9.1 days in the monthly dosing, quarterly dosing, and placebo groups, respectively. During the 12-week period after the first dose, fremanezumab treatment significantly reduced monthly migraine days to 4.6 days for monthly and 4.9 days for quarterly dosing compared with 5.9 days for placebo. Response rates of at least 50% reduction in monthly average number of migraine days were also significantly greater in monthly (47.7%) and quarterly (44.4%) dosing compared with placebo (27.9%).

Additionally, the baseline mean number of monthly days of any acute headache medication use was 7.7, 7.9, and 7.7 days in the monthly, quarterly, and placebo groups, respectively. Fremanezumab significantly reduced monthly days of any acute headache medication use to 4.5 days for monthly and 4.6 days for quarterly dosing compared with 5.4 days for placebo. The most common adverse events in patients treated with fremanezumab were injection site pain, induration, and erythema.

See: Effect of Fremanezumab Compared With Placebo for Prevention of Episodic MigraineA Randomized Clinical Trial


You will need to login, to leave a comment. is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Cushing's Syndrome

Cushing's Syndrome

Cushing’s syndrome shares symptoms such as hypertension, glucose intolerance and obesity with other common conditions – how can you confidently diagnose this rare disorder?

+ 2 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Load more

Related Content