The U.S. Food and Drug Administration (FDA) said that it has concerns over the safety of an ultrasound contrast agent developed by Acusphere of Watertown, MA, that is currently under regulatory review at the agency.
In an announcement on December 8, the FDA said that it is concerned about the safety of Acusphere's AI-700 contrast agent due to "signals evidenced in animal and clinical studies," particularly in light of recent developments regarding the safety profiles of microbubble-based contrast agents. The agency's Cardiovascular and Renal Drugs Advisory Committee is scheduled to review AI-700's new drug application (NDA) on December 10.
The FDA in 2007 required black box warnings for the two ultrasound contrast products on the U.S. market, Definity from Lantheus Medical Imaging of North Billerica, MA, and Optison from GE Healthcare of Chalfont St. Giles, U.K.
In the clinical trials supporting AI-700's NDA, the product was administered to 1,194 subjects, including 911 patients with known or suspected coronary artery disease. The goals of the studies were to demonstrate that AI-700 could be used to triage patients for referral to coronary angiography, and to demonstrate that the agent was not "importantly inferior" to another angiography screening tool, myocardial perfusion SPECT.
The agency said that serious adverse events were reported in 1% of patients (11/911), including three patients who experienced vasovagal syncope following AI-700 injection. Some 4% (38/911) experienced hypotension or decreased blood pressure, while 2% (16/911) had AI-700 permanently discontinued because of adverse events.
The FDA said that it expected to ask a variety of questions regarding AI-700's safety profile, such as whether the product's diagnostic efficacy and potential clinical usefulness justifies exposure to the risks associated with the agent.
Investors hammered the company's stock after learning of the announcement, with Acusphere shares closing at 42¢ on December 8, down 56%.
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Acusphere reports Q2 results, August 12, 2008
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