Vernalis' V1003 performs well in pain study

UK-based pharmaceutical company Vernalis says that a Phase IIa study of its developmental intranasal formulation of buprenorphine, V1003, used in the management of post-operative pain, has met its primary endpoint of pain relief eight or more hours after drug administration.

During the trial, the drug was assessed at dosages of 0.1mg, 0.2mg, 0.4mg and 0.6mg in comparison with Vicodin (hydrocodone 10mg, paracetamol 1g) and placebo. When analyzed, the results showed that, at doses of 0.2mg and above, V1003 was statistically-superior to placebo for the primary end point. Only the 0.6mg dose of V1003 was more effective than Vicodin to a level of statistical-significance, although a strong trend towards superiority was observed across all doses of V1003 greater than 0.2mg. The firm also says that there were no serious adverse events during the program. Less serious adverse events included nausea, vomiting, dizziness, sleepiness and some irritation of the nasal passages, the site of drug administration.

Vernalis acquired the drug through its purchase of Ionix last year (Marketletter July 11, 2005) and is collaborating on the further development of the compound with fellow UK firm Reckitt Benckiser, with the latter funding all R&D costs in return for milestone payments and future royalties on commercial sales. Additionally, Vernalis says it is using Archimedes Pharma's drug-delivery technology, which it also gained in its purchase of Ionix under a pre-existing deal the latter had with Archimedes.