WASHINGTON, Dec 8 (Reuters) - Safety risks with Acusphere Inc's (ACUS) Imagify may be "inappropriate" for use in diagnosing patients with heart problems, U.S. Food and Drug Administration staff said in documents released on Monday, sending the company's shares down 60 percent.
"FDA is particularly concerned about the safety ... because of signals evidenced in animal and clinical studies," the staff said. "FDA is also concerned that the safety risks associated with the product are inappropriate for the product's proposed clinical use."
Acusphere is seeking FDA approval to market the injectable suspension for use in ultrasound imaging tests to help diagnose coronary artery disease.
The FDA staff documents were released ahead of an advisory panel meeting on Wednesday to discuss whether the agency should approve the product. The FDA usually follows the recommendation from its panel of outside advisers.
Imagify is a type of imaging contrast agent known as a "microsphere" drug with small, gas-containing particles. It is injected into the bloodstream to make the body's vascular system easier to see.
FDA officials earlier this year expressed concern about the safety of contrast imaging agents overall.
In their analysis released on Monday, FDA staff said many complications were reported in patients given Imagify, including abnormally low blood pressure, blue discoloration of the skin and shaking, but it was difficult to tell whether they were caused by the drug or the accompanying test.
Agency staff also said they were concerned about inconsistent findings on how well the ultrasound imaging agent works, calling the data "not sufficient."
Acusphere, in separate documents also released on Monday, said most side effects were not serious and were treatable.
Use of Imagify appears to work as well as another imaging tests and "will be an effective clinical tool in the triage of patients" who may need more invasive procedures," the company said.‹
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