AcelRX Pharmaceuticals Inc said its experimental treatment for post-operative pain met its main goal in a late-stage trial of patients who had undergone knee or hip replacement surgery, sending its shares up 15 percent.
AcelRX said its Sufentanil NanoTab PCA System showed a decrease in pain intensity, compared with a placebo, as measured on a clinical scale 48 hours after surgery.
In the last of three late-stage trials, the drug-device combination also significantly reduced pain compared with a placebo 24 hours and 72 hours after surgery, the company said.
AcelRX said it remained on track to file a marketing approval application with the U.S. Food and Drug Administration in the third quarter.
The NanoTab treatment is designed to allow patients to self-administer sufentanil, a generic painkiller that is currently delivered intravenously or through a spinal injection.
AcelRX said that adverse events, including nausea, reported in the trial were "generally mild or moderate".
The trial enrolled 426 adult patients for the treatment of moderate to severe acute pain.
The therapy had shown in the two previous late-stage trials that it was at least as effective as the standard of care in treating post-operative pain and was significantly better than a placebo.
AcelRX's shares were up 7 percent at $6.95 in morning trade on the Nasdaq.
(Reporting By Vrinda Manocha in Bangalore; Editing by Sriraj Kalluvila and Robin Paxton)