AcelRx falls as FDA requests additional Zalviso trial
AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) fell $3.23 (37%) to $5.51 on news that the company will delay its resubmission of an NDA for Zalviso sufentanil sublingual tablet system after FDA requested an additional clinical trial to "assess the risk of inadvertent dispensing and overall risk of dispensing failures." AcelRx had hoped to resubmit the NDA this quarter.
In July 2014, AcelRx received a complete response letter from FDA for an NDA for Zalviso to treat moderate to severe acute pain. The company said FDA requested additional information to "ensure proper use" of the pre-programmed, handheld device that delivers a sublingual formulation of sufentanil, a synthetic opioid analgesic. In the letter, FDA did not request additional clinical trials (see BioCentury Extra, July 28, 2014). ...