MGI Pharma: Phase 2 study of Aquavan for sedation shows promising results

By E. Janene Geiss

Philadelphia, Dec. 21 - MGI Pharma Inc. said Wednesday that top line results from a randomized, double-blind, multi-center phase 2 dose-ranging study of Aquavan (fospropofol disodium) injection in patients undergoing colonoscopy showed that the 6.5 mg and 8.0 mg doses of Aquavan were statistically superior to the 2.0 mg or 5.0 mg bolus doses with regard to the sedation success endpoint.

The company also said a pivotal program is planned for this treatment in early 2006.

The Aquavan injection is being tested for use as a sedative in patients undergoing procedures requiring minimal to moderate sedation, officials said.

A phase 2 dose-ranging study was conducted to determine the dose-response relationship of Aquavan injection for endpoints of sedation success, patient satisfaction, investigator satisfaction and safety.

A total of 127 adults undergoing colonoscopy were randomized to receive one of four different initial bolus doses of Aquavan Injection (2.0, 5.0, 6.5, or 8.0 mg) or midazolam (0.02 mg/kg) following pretreatment with fentanyl citrate.

Following administration of the initial bolus dose of study drug, the design of this trial allowed supplemental doses to be administered to reach and maintain minimal to moderate sedation during the procedure.

Study drugs were administered by medical personnel as dictated by local investigative site guidelines. Administration by an anesthesiologist was not required, officials said.

The results of the study show the 6.5 mg and 8.0 mg doses of Aquavan injection were statistically superior to the 2.0 mg or 5.0 mg bolus doses of Aquavan injection with regard to the sedation success endpoint.

In a blinded survey, investigators treating 92% of the patients receiving an initial bolus dose of 6.5 mg indicated that they would again choose Aquavan injection for procedures needing moderate sedation, compared to the responses of investigators administering the 8.0 mg dose of Aquavan Injection (83%) or midazolam (77%).

Data from this study also indicate that patients treated with Aquavan required fewer supplemental doses to achieve initial sedation compared to those who received midazolam, officials said.

More than 90% of patients who received Aquavan required two or fewer supplemental doses during initiation of sedation, compared with 58% of patients who were treated with midazolam, officials said.

The pivotal development program for Aquavan is expected to begin in early 2006 and will consist of two randomized, double-blind, multi-center phase 3 trials and an open label safety study.

The first pivotal trial will enroll 300 patients undergoing colonoscopy. The second pivotal study is planned to enroll 250 patients undergoing bronchoscopy.

The endpoints of both pivotal trials include sedation and treatment success, patient satisfaction, investigator satisfaction and measures of sedation adequacy, recovery, clinical benefit and safety, officials said.

In addition to the two pivotal trials, an open label, multi-center safety study will be conducted in 150 patients undergoing minor procedures, including arthroscopy, bunionectomy, dilation and curettage, endoscopy, hysteroscopy, lithotripsy, shunt placement and trans-esophageal echoes.

The goal of this study will be to assess the safety of a single dose of Aquavan in a variety of minor surgical procedures, officials said.

MGI Pharma is a Minneapolis biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that focus on oncology and acute care.

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