(Reuters) — AcelRx Pharmaceuticals (NSDQ:ACRX) said a division of the FDA rejected its request for a meeting to discuss the need for an additional trial of its pain drug device, Zalviso.
ACRX shares fell about 32% to $2.85 in after-market trading today 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.
The company said it’s "consulting with our regulatory, legal and clinical advisors to determine our next steps."
