Ph I data for Evotec's anti-smoking drug

Germany's Evotec has reported results from a Phase I safety study investigating the potential interaction of EVT 302, a reversible and highly selective inhibitor of monoamine oxidase B in development for smoking cessation, with tyramine.

The trial was a double-blind study in 59 healthy young male subjects. It assessed whether EVT 302 (administered at three different doses up to steady state) resulted in an increase in the sensitivity to tyramine in enhancing blood pressure. The study included selegiline, a marketed MAO-B inhibitor with less selectivity than EVT 302 over MAO-A, and as an active comparator.

Results showed that the therapeutic dose of selegiline did increase the sensitivity to tyramine compared to placebo. At the highest dose tested (less than five times the expected therapeutic dose), a small increase in tyramine sensitivity was produced, which was within the range of that by the therapeutic dose of selegiline.