Futura Medical PLC (LON:FUM) said it enjoyed a positive interaction with the US drug regulator which should pave the way for its erectile dysfunction gel to be sold over the counter.
The Food & Drug Administration has agreed the design of a non-clinical human factors study, which will assess the ability of men to self-diagnose and correctly select the product without a doctor’s supervision.
It requires a minimum of 15 participants to complete the evaluation, with work expected to get underway in the second quarter of next year.
Futura said the agreed design is subject to the issue of the final minutes from its meeting with FDA officials.
At the same time, planning is underway for a confirmatory clinical trial of the treatment with the first dosing expected sometime this quarter.
Over-the-counter marketing authorisation in the US for MED3000 is “remains on track” for the first quarter of 2023.
In the same announcement, investors were told manufacturing scale-up and capacity to meet projected demand is “progressing”.
It is also in negotiations with potential partners over commercial out-licensing agreements covering the “remaining major regions and countries of the world”. It expects to launch the product in one of its major markets next year.