Guilford Pharmaceuticals Inc announced that the company has initiated a Phase III clinical development program for Aquavan Injection, a novel sedative/hypnotic. The program is consistent with feedback received from the Division of Anesthetic, Critical Care and Addiction Drug Products of the U.S. Food & Drug Administration.

Craig Smith, CEO of Guilford, remarked, "We held an end-of-Phase II meeting with the FDA. During the meeting we discussed our proposed indication, clinical trial plan, and other requirements for a potential future New Drug Application (NDA) for Aquavan. Based on these discussions it is our intention to complete the necessary clinical trials and file a NDA as soon as possible. We intend to seek approval for Aquavan for mild to moderate sedation for brief diagnostic and therapeutic procedures such as colonoscopy, bronchoscopy, interventional cardiology and minor surgical and therapeutic procedures."

The company also announced that it has completed a Phase II study of Aquavan designed to test the efficacy of the dose regimen of Aquavan, which the Company plans to use in the Phase III program. The Phase II study enrolled a total of 64 patients who received Aquavan for procedural sedation during colonoscopy. The company plans to release the data in the third quarter.

The Phase III program will consist of four Phase III trials and a series of smaller studies in special patient populations. The four Phase III trials will be conducted in patients undergoing 1) colonoscopy, 2) bronchoscopy, 3) cardiac procedures, and 4) minor surgical procedures. The first two trials will be randomized comparisons with midazolam. All patients will receive fentanyl citrate for analgesia.

The primary endpoint will be success of sedation as determined by a score of less than 4 using the Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale. Secondary endpoints will include time to fully alert and time to fully recovered and duration of sedation. It is anticipated that the investigator's medical staff will administer Aquavan in the Phase III program.

The US FDA recommended Guilford also conduct a series of smaller studies in special patient populations such as burn patients, patients undergoing upper endoscopy prior to liver transplant and patients having an arterovenous shunt placed for renal dialysis. Guilford anticipates approximately 900 patients will be enrolled in upcoming studies and data from approximately 1200 patients will be included in the NDA submission for Aquavan.