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FDA rejects AcelRx's
request for meeting on pain drug device
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[May 05, 2015]
(Reuters) - AcelRx Pharmaceuticals
Inc said a division of the U.S. Food and Drug Administration had
rejected the company's request for a meeting to discuss the need for an
additional trial of its pain drug device, Zalviso.
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 The company's shares fell about 32 percent to $2.85 in after-market
trading on Monday after the FDA also restated its view that the
additional study was needed.
The agency, in March, asked AcelRx to conduct the study to evaluate
risks associated with the device, specifically issues relating to
inadvertent dispensing.
The additional trial is likely to push Zalviso's approval to the end
of 2016, against the previous estimate of early 2016, according to
analysts.
"We are consulting with our regulatory, legal and clinical advisors
to determine our next steps," the company said.
(Reporting by Amrutha Penumudi in Bengaluru; Editing by Simon
Jennings)
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