A pharmacokinetic study assesses the absorption of the medication – in this case, a gel glyceryl trinitrate, or GTN for short – its distribution, how it is metabolised and, finally, how it is excreted.
At higher doses than the 0.2% administered in a previous phase II assessment, MED2005 was rapidly absorbed, showed good bioavailability (which means it had an active effect when it entered the blood) and an “acceptable safety profile”.
It was compared with Nitrostat, a similar drug, but for angina, which is taken by mouth. The doses were 0.2%, 0.4% and 0.6% GTN.
The results also demonstrated that plasma concentrations of GTN and its two major metabolites increased proportionally with the escalating MED2005 dosage.
Futura said the result was “highly encouraging”. It added that it strongly believes higher dose forms of MED2005 will improve efficacy with an acceptable safety profile.
At the same time, the data could help support a simplified 505(b)2 regulatory pathway for the drug under the US Food & Drug Administration’s protocols.
The read-out from the pharmacokinetic study will be presented to the Annual Fall Scientific Meeting of the Sexual Medicine Society of North America taking place currently in Miami.
Good to share
Futura chief executive James Barder said: “We are very pleased to share in more detail these meaningful findings on our lead programme MED2005 with the medical community at this prestigious meeting.
“These PK data demonstrate the potential of MED2005 as a safe and fast-acting erectile dysfunction treatment with a favourable side effect profile, a key differentiator to other ED products on the market.”
The treatment is being developed for men who can’t take orally administered erectile dysfunction drugs such as Viagra and Cialis because of side effects such as headaches.
The fast-acting gel is currently undergoing a phase III clinical trial in a patient group that will eventually total 1,000 men with mild, moderate and severe erectile dysfunction.