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LONDON (Alliance News) - N4 Pharma PLC said Wednesday that it has commenced proof of concept clinical trial for erectile dysfunction treatment drug sildenafil, following the completion of the validation of the reformulated drug.
The pharmaceutical company said the trial will comprise a four way crossover study in 12 healthy subjects comparing N4 Pharma's reformulated 100 milligram sildenafil to Viagra 50 milligram in both fed and fasted conditions. The trial is expected to take eight to 10 weeks with provisional results data available in July, with the final clinical study report expected at the end of August.
N4 Pharma said the trial will enable the company to establish whether its reformulation has been sufficiently successful to allow N4 Pharma to prepare for a pre-IND meeting with the FDA towards the end of this year or whether further amendments are required to optimise efficacy.
"The board continues to believe that the improvements sought to be evidenced through the Trial will make our reformulation that much more attractive to both the end consumer and pharmaceutical partners in the final development and commercialisation of the drug in this highly lucrative market," said Chief Executive Nigel Theobald.
Shares in N4 Pharma were trading 1.0% higher at 22.96 pence Wednesday.
