MGI Pharma Submits NDA For Aquavan Injection

(RTTNews) - Thursday, MGI Pharma Inc. (MOGN | charts | news | PowerRating), a biopharmaceutical company, said it has submitted a New Drug Application or NDA for Aquavan or fospropofol disodium Injection with the FDA for review.

In its NDA, the company has included data from phase 2 and phase 3 trials in patients colonoscopy, a phase 3 trial in patients undergoing bronchoscopy, and an open label study in patients undergoing a variety of minor surgical procedures. Overall, data from 21 clinical studies involving 1,611 patients were included in the NDA.

The company conducted a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan Injection for sedation in patients undergoing bronchoscopy, in which patients successfully met the primary endpoint of sedation success as well as all secondary endpoints.

MGI also conducted a randomized, double-blind, multi-center phase 3 pivotal trial to evaluate whether an Aquavan dosing regimen of 6.5 mg/kg would be safe and effective in providing moderate sedation in patients undergoing colonoscopy, compared to a control dose of 2.0 mg/kg. About 87% of the patients met the primary endpoint.

Further an open label study conducted in patients undergoing a variety of minor surgical procedures showed that no adverse events led to procedure or study drug discontinuation.

Aquavan is an investigational drug that is being studied as a sedative-hypnotic agent in patients undergoing brief surgical or diagnostic procedures.

MOGN is currently trading at $27.45, up 94 cents or 3.55%.

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