AcelRx Pharmaceuticals' ($ACRX) under-the-tongue formulation of the opioid painkiller sufentanil came out better than IV morphine in a Phase III study of patient-controlled analgesia (PCA) in postoperative pain. The sublingual formulation, known as the NanoTab PCA System, is a completely noninvasive preprogrammed handheld system and avoids the complications and inconveniences of IV drug administration.
In a study of 359 adults across the U.S. who were given either AcelRx's sublingual drug or IV morphine immediately after major abdominal or orthopedic surgery for 48 to 72 hours, patients reported that the under-the-tongue formulation was better than IV morphine in controlling pain. Both nurses and patients said they were more satisfied with the under-the-tongue version and found it easier to use. The company's shares rose 25% on the news.
"Our goal at AcelRx has always been to improve upon the management of postoperative pain using a simplified system that nurses don't have to program," commented Pamela Palmer, AcelRx's chief medical officer and co-founder.
The company's next step is to complete its two ongoing Phase III trials in pain control after open abdominal surgery and joint-replacement surgery. Data from these are expected in the first quarter of 2013. The company will then head toward commercialization.
- read the press release