Bracco Diagnostics' SonoRx, the first oral contrast agent for ultrasound imaging, will be available by the end of the year, the company said following its Oct. 29 FDA approval. SonoRx is intended to reduce gas shadowing during upper abdominal ultrasound procedures, a problem that can obscure the radiologist's view regardless of the type of ultrasound equipment used.

The product will be launched at a cost of approximately $25-$30 per vial, the amount required for a single procedure. Bracco's marketing research indicates that gas shadowing is problematic in 300,000 upper abdominal procedures each year in the U.S. Gas is present in 1.5 mil. upper abdominal cases overall, though it often is not a factor.

Labeling describes SonoRx (simethicone coated cellulose suspension) as "an orally administered gas shadowing reduction agent that is indicated to enhance the delineation of upper abdominal anatomy in conjunction with ultrasound imaging."

Labeling describes two clinical studies involving patients who were "highly suspected" of having upper abdominal pathology and were referred for abdominal ultrasound imaging. The images were scored before and after SonoRx administration on a scale of 0-4 for presence of gas shadowing artifacts and delineation of anatomic organs.

"SonoRx images provided a statistically significant improvement over baseline of at least one unit in the delineation of the stomach, gastric wall, pylorus, duodenum and pancreas," labeling says. The proportion of patients whose anatomic delineation improved after SonoRx ranged from 64%-80% for the stomach, 58%-80% for the gastric wall, 47%-69% for the pylorus, 44%-67% for the duodenum, 17%-54% for the pancreatic head, 13%-46% for the pancreatic body and 30%-45% for the pancreatic tail.

Recommended dosing of SonoRx is 400 mL orally, taken over 15 minutes, following at least four hours of fasting. Imaging should start within 10 minutes.

Labeling warns that ingestion of SonoRx may cause vomiting that could be associated with aspiration. "It is likely that patients who have tracheosophageal fistula may aspirate. Precautions should be taken to avoid aspiration," labeling advises.

Bracco's SonoRx Is First Oral Contrast Agent For Upper Abdominal Imaging

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