AcelRx Pharmaceuticals Inc (Nasdaq:ACRX), a pharmaceutical group that develops therapies for the treatment of acute pain, has finished its human factors study, which was designed to show the effectiveness of its painkiller DSUVIA’s usage directions.
The completion of the human factors study marks the last step required to prepare AcelRx’s DSUVIA’s new drug application, which is set to be resubmitted to the US Food and Drug Administration in the second quarter of this year.
In morning trade, AcelRx shares rose 4.7% to US$2.35.
“This study was the first of our key 2018 milestones outlined on our year-end earnings call,” said Vince Angotti, chief executive of AcelRx, in a statement. “We remain focused on the achievement of each of these key milestones, which we believe will enable 2018 to be a transformational year for AcelRx.”
DSUVIA consists of 30mcg of sufentanil in small tablets, taken under the tongue, which are delivered via a disposable, pre-filled single dose applicator. The drug is intended to be used to manage acute pain in emergency medicine, outpatient surgery and surgeries when only a short stay is required.
The completion of the human factors study was recommended by the FDA after AcelRx submitted recommended changes to the directions accompanying DSUVIA.