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N4 Pharma firms up details for erectile dysfunction drug trial
Specialist pharmaceutical company N4 Pharma announced on Wednesday that it has commenced a proof of concept clinical trial for its lead product, erectile dysfuncion drug sildenafil.
The trial, a four way crossover study in 12 healthy subjects comparing 100mg sildenafil to 50g Viagra in fasted conditions, follows the successful validation and reformulation of the drug in accordance with specifications submitted to the Medicines & Healthcare Products Regulatory Agency (MHRA).
Nigel Theobald, chief executive of N4 Pharma, said: "Slight delays in receiving the base ingredients to the reformulation, which had a knock effect on the validation of the product, has seen the timetable slip slightly. However, there should be no material impact on any move towards commercialisation assuming successful trial results."
The eight to ten week trial will monitor the level of the drug present in plasma over a 24-hour period as the reformulation is aimed at increasing the speed at which the drug takes effect and extending its duration.
AIM-traded company N4 Pharma hopes the study will establish whether reformulation has been successful enough for the company to prepare for a meeting with the US Food and Drug Administration (FDA) concerning an Investigational New Drug Application.
"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 Theobald.
Provisional results are expected to be available in July before a full clinical study report is published in August.
As of 0842 BST, N4 Pharma's shares were up 6.59% at 24.25p.