Vernalis announces the start of Phase II Clinical Trial of V1003 in Acute Post-Operative Pain
22 August 2005 Vernalis plc (LSE: VER, NASDAQ: VNLS) announced today that V1003 (formerly known as IX-1003), a proprietary intranasal formulation of buprenorphine, has started Phase II clinical testing. The randomised, double-blind, placebo-controlled, single dose Phase II study in 360 patients is comparing the efficacy of V1003 to placebo in patients with moderate to severe pain. Additionally, the study will provide information about the speed of onset and tolerability of the compound. The trial is expected to complete in 1H 2006.
V1003 was acquired by Vernalis through its recent purchase of Ionix Pharmaceuticals Limited and the programme is partnered with Reckitt Benckiser Healthcare, who manufacture and market buprenorphine globally. The Phase II trial triggers a significant milestone payment to Vernalis. Reckitt Benckiser is responsible for future development costs with Vernalis receiving a series of further payments upon achievement of development milestones, as well as royalties on commercial sales. On the completion of the Phase II trial, Vernalis has retained the right to co-promote the product in the US and, should it exercise this option, will contribute to a proportion of the costs in return for a share of profits.
Simon Sturge, CEO of Vernalis, commented, 'V1003 is a well known opiate analgesic and this intranasal formulation has the potential to provide a convenient alternative to other opiate analgesics currently on the market and to allow patients to manage their post operative pain prior to discharge from hospital and at home during their recovery period.' |