Meditor migraine drug achieves trial goals

This Phase II study was designed to assess the pharmacokinetics, safety and efficacy of MTR106 in female patients suffering from migraine without aura. The study population consisted of 40 female patients ranging from 22 to 57 years of age. The average duration of migraine attacks was 16.6 +/- 10 hours with a frequency of 2.8 +/- 1.3 attacks per month.

The subjects were randomized in a ratio of 4:1 treatment to placebo respectively, constituting four groups of 10 patients each. Treatment arms of MTR106 or placebo were administered at escalating doses of 25, 50, 75 and 100mg.

MTR106 was found to be safe and well tolerated. No serious adverse events occurred in the four studied doses and no symptoms related to chest pain or changes in heart rate or blood pressure were observed. The study results demonstrated that at two hours and at the third and fourth hours post-treatment, more patients treated with MTR106 had pain relief compared to those treated with placebo.

MTR104 is a low molecular weight S-alkylisothiouronium derivative that addresses a variety of acute and chronic therapeutic indications associated with hypotension.