Futura Medical PLC (AIM:FUM, OTC:FAMDF) has confirmed the submission of a comprehensive response to the US Food and Drug Administration (FDA) regarding its innovative topical gel treatment for erectile dysfunction (ED), known as MED3000.
It has now provided all requested information and confirmatory data, allowing the regulatory body to continue its review of MED3000.
The company said it remains optimistic about receiving a De Novo request approval in the second quarter, in line with the FDA's published target review period guidelines.
Listed on the AIM market under the ticker FUM, Futura is known for its proprietary DermaSys technology and has a strong focus on sexual health and pain management.
MED3000, its ED treatment, uses a topical gel formulation designed to provide a fast groundbreaking solution for ED sufferers that can’t take traditional ‘blue pill’ medication for the condition.
Once the green light has been given, the company expects the gel to be the first over-the-counter erectile dysfunction product in the US.