Pharmacyclics To File NDA For Gadolite

Pharmacyclics is to file a New Drug Application in the USA following a positive preliminary analysis of a Phase III trial of its oral magnetic resonance imaging agent Gadolite (gadolinium alumina silicate oral suspension).

The study, involving 15 centers in the USA and Australia, enrolled patients with known or suspected diseases of the abdomen or pelvis. By causing contrast enhancement of the entire gastrointestinal tract, Gadolite enables the radiologist to distinguish the fluid-filled GI tract from adjacent tissues. The agent was well tolerated, was not absorbed and is capable of improving the interpretation of MRI scans of the abdomen and pelvis, reported the company. It is also able to reduce the need for follow-up procedures.

If approved, Gadolite will be the only actively-promoted MRI GI contrast agent on the US market. Alliance Pharmaceutical's Imagent GI (perflubron) was approved for use in GI imaging in August 1993, but the company no longer promotes the product. Alliance reported that the $200 per dose price of the agent made it unmarketable. Pharmacyclics says that Gadolite is less costly to manufacture than Imagent GI.