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Futura Medical kicks off dosing and safety study that will guide phase III trials

Published: 07:25 29 Nov 2017 GMT

paper with clinical trial on it
The pharmacokinetic study is a prelude to final stage clinical trials

Futura Medical plc (LON:FUM) said it has begun recruitment for a pharmacokinetic study of its lead product, MED2002, which is a prelude to starting phase III trials of the breakthrough gel for erectile dysfunction.

Data from 40 men will determine the doses used in the final-stage clinical assessment MED2002, which will kick off as “soon as practicable” after the current programme.

READ: New survey 'reinforces potential' for Futura Medical's erectile dysfunction gel

The pharmacokinetic (PK) study is expected to be complete by the first quarter of next year and researchers will also look at the gel’s safety profile compared with approved angina treatments, which have the same active pharmaceutical ingredient.

Cost effective approach

“By pre-screening formulations at a number of dosage strengths, the PK study will enable the phase III studies to be run as expeditiously and cost effectively as possible,” said Futura chief executive James Barder.

There is a significant potential market for an alternative to the current erectile dysfunction treatments.

READ: Most doctors think Futura’s erectile dysfunction gel is an improvement on Viagra and Cialis

People report side effects such as headaches and heartburn from taking Viagra and Cialis, while for others the blue pill isn't an option as it clashes with existing medication they are being prescribed.

Research has found a widespread dissatisfaction with these sorts of drugs with the speed of onset cropping up as the most common complaint.

Alternative treatment

MED2002 provides a far more rapid solution to the current crop of pills - two to three minutes before the effect is felt versus 20.

All of this provides an opportunity - a ready-made market of men who either can't or don't like taking the current help available.

This potential was highlighted by market research announced in October, which found that more than 60% of US doctors consider MED2002 to be an improvement over current treatments.

"MED2002 has huge potential as a prescription medicine,” said CEO Barder.

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