REDWOOD CITY, Calif. — A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.
AcelRx Pharmaceuticals announced the dosing of the first patient in a phase-3 trial of ARX-01 (sufentanil), also called the Sufentanil NanoTab PCA System, a patient-controlled analgesic therapy designed to be placed under the tongue in patients who have undergone hip or knee-replacement surgery. The drug is designed as an alternative to treatments that involve intravenous pumps delivering morphine.
"The start of our third phase-3 clinical trial for ARX-01 is an important milestone for our lead sufentanil NanoTab development program," AcelRx president and CEO Richard King said. "The results of all three phase-3 registration studies are expected to form the basis of a new drug application for ARX-01, which we plan to submit to the [Food and Drug Administration] during the third quarter of 2013."
The study will enroll approximately 400 patients, who will receive either Sufentanil NanoTabs or placebo NanoTabs.