N4 Pharma's Viagra reformulation fails to meet trial targets
Specialist pharmaceutical company N4 Pharma announced the initial findings from analysing the preliminary results of the pharmacokinetic data from its clinical trial for the reformulation of sildenafil - commonly known and sold as ‘Viagra’ - on Monday.
The AIM-traded firm said that, while it was yet to receive the full results from the clinical trial, it was apparently “clear” from the preliminary pharmacokinetic data that the current formulation had not met the key target endpoints of the trial.
To that end, it said the product formulation would need to be reviewed to assess what changes would be required to make the reformulated drug viable in the context of the company's patent position.
“This part of the process of drug reformulation is always going to be a challenge and whilst this preliminary data is clearly disappointing, we will need to see the full set of results expected around the end of August to understand the detailed implications for the formulation,” said N4 Pharma chief executive officer Nigel Theobald.
“We will provide a further update once we have had a chance to review all the findings from the trial about the next steps we will take to reformulate the product.
“Our ‘nuvec’ development program continues as planned and as advised earlier we will release further news on these results in the fourth quarter of this year.”