Futura Medical has reported details of its third meeting with the FDA that firmed up the format of the six-month confirmatory study. The new trial, known as FM71, will involve c 100 patients with erectile dysfunction (ED). Around c 20 will be in the US and the balance will be similar to those who took part in the FM57 Phase III trial. The primary endpoint is efficacy against baseline assessment. The important secondary endpoints relate to speed of onset of effect and adverse events. There is no placebo and a comparison arm, using 5mg tadalafil (Cialis), will employ the same endpoints and provide an appropriate reference frame for an overall MED3000 risk/benefit analysis.
26 Oct 2020
MED3000: FDA details the scope of confirmatory study
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MED3000: FDA details the scope of confirmatory study
Futura Medical plc (FUM:LON) | 35.7 -0.1 (-0.6%) | Mkt Cap: 107.7m
- Published:
26 Oct 2020 -
Author:
Franc Gregori | Lala Gregorek -
Pages:
2
Futura Medical has reported details of its third meeting with the FDA that firmed up the format of the six-month confirmatory study. The new trial, known as FM71, will involve c 100 patients with erectile dysfunction (ED). Around c 20 will be in the US and the balance will be similar to those who took part in the FM57 Phase III trial. The primary endpoint is efficacy against baseline assessment. The important secondary endpoints relate to speed of onset of effect and adverse events. There is no placebo and a comparison arm, using 5mg tadalafil (Cialis), will employ the same endpoints and provide an appropriate reference frame for an overall MED3000 risk/benefit analysis.