BALTIMORE, Md — Guilford Pharmaceuticals Inc. recently announced that it had met with the Division of Anesthetic, Critical Care and Addiction Drug Products of the FDA and reached agreement on a revised clinical development strategy for the company’s lead product candidate, AQUAVAN
Dean J. Mitchell, President and Chief Executive Officer of Guilford, commented, “Following a very collaborative discussion with the FDA, we have agreed on a more focused clinical development strategy that reduces the number of clinical trials from 13 to 5 and includes a dose ranging study in colonoscopy. We expect that the dose ranging study will result in our identifying a dose of AQUAVAN® that will maximize our ability to achieve our desired label. In addition, we believe that this less complex clinical plan increases the probability of FDA approval within an optimal timeframe.”
Under the revised strategy, Guilford will immediately re-initiate its previously planned studies for ICU sedation and potential drug interactions. The design of the dose ranging trial in colonoscopy is being finalized in consultation with the FDA. Based on the findings of this study, Guilford expects to commence two pivotal trials, one in colonoscopy and the other in minor surgical procedures. Guilford continues to expect to file its New Drug Application (NDA) for AQUAVAN® during the second half of 2006.
Mr. Mitchell continued, “We are strongly committed to the successful and expeditious development of AQUAVAN®. The unique pharmacological profile of AQUAVAN® is optimally aligned with patient and physician needs in the procedural sedation market and offers a compelling value proposition which we believe will confer significant pharmacoeconomic benefit.”