Teva announces FOCUS study met primary, secondary endpoints

Teva Pharmaceutical Industries announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo over the 12 week assessment period, for both monthly and quarterly dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. There were no safety signals detected in the study. Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication. The Phase IIIb FOCUS study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to two to four classes of prior preventive treatments were enrolled in the study. Inadequate response is defined as: lack of efficacy after at least three months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid. In the study, chronic migraine and episodic migraine patients were randomized in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months followed the placebo-controlled portion of the study.
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