NEW YORK (TheStreet) -- Shares of AcelRx Pharmaceuticals (ACRX) - Get Report plunged to a 52-week low of $5.27 on Friday after the company announced a delay in resubmitting its experimental pain management treatment device Zalviso for FDA approval.
The Redwood City, CA-based AcelRx announced in July it planned to resubmit the new drug application by the end of 2014. But the company said Friday the new target date is the first quarter of 2015 and even cautioned the resubmitted application could come later than that.
The FDA had concerns about Zalviso, designed for moderate to severe pain in hospital environments, in July and asked for more information on optical system errors and Zalviso's shelf life, along with other items. AcelRx said it reviewed those questions with the FDA in a recent teleconference.
"The discussion with the FDA was productive," said president and CEO Richard King. "Over the coming months we will prepare, submit and finalize with the FDA the protocols required to complete this work."
AcelRx added the review period for the resubmitted application would be six months.
The stock was down 18.9% to $5.45 at 3:20 p.m. More than 3.6 million shares had changed hands, compared to the average volume of 1,115,170.