Reportedly, the study enrolled 271 subjects with neuropathic pain caused by underlying diabetes into a 2-week placebo run-in period. Following this, 162 subjects were enrolled into a 13-week, double blind, placebo controlled treatment phase in which they were randomised to receive placebo or up to 400mg of indantadol twice a day.
In the study, although there was a 25% reduction compared to baseline in pain scores in patients who received V3381, there was also a marked reduction in the placebo-treated subjects and consequently no significant difference between the two treatment groups.
Vernalis is unlikely to conduct further studies with V3381 in neuropathic pain due to diabetes. However, the ongoing pilot trial for the product in chronic cough will be completed, and the data assessed in the normal way to decide whether it should be progressed to the next stage of development, said the company.
Ian Garland, CEO at Vernalis, said: “We have consistently stated the highly risky nature of diabetic neuropathy studies but nevertheless are disappointed with the results of the In-Step study in this difficult to treat indication. However, Vernalis has a broad portfolio of products in clinical trials addressing substantial market opportunities.
“This, combined with the royalties from increasing sales of frovatriptan and significant existing cash resources that fund us for at least three years at current research and development investment levels, continues to give Vernalis strong potential for growth and value generation.”