AcelRx Pharmaceuticals Inc (ACRX) is preparing for the U.S. launch of its novel lead product candidate Zalviso, which through late stage clinical tests has shown the ability to manage postoperative pain nonintravenously, says Richard King, Director, President and CEO of AcelRx Pharmaceuticals Inc.
“AcelRx fundamentally set out to come up with a different opioid to manage postoperative pain than morphine or hydromorphone, delivered nonintravenously through a preprogrammed delivery device. We’ve now come to the end of our Phase III studies, had great success with our technology that we’ve developed to meet that challenge, and we’re now getting ready to file our NDA to approve the drug in the United States,” King said.
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Zalviso is a new technology that uses an opioid called sufentanil, which is delivered under the tongue, King says. The sufentanil then leaches into the plasma to get delivered to the effector site in the brain where the opioid receptor is located. With the technology’s success in the company’s late stage studies, King expects ACRX to begin to commercialize Zalviso in the last quarter of 2014 upon FDA approval.
“We’ve completed all of our late stage clinical tests, including two placebo-controlled studies and one active comparative study against intravenous patient-controlled analgesia with morphine; all very successful studies, clearly demonstrating that our new technology, Zalviso, has an ability to manage postoperative pain well while also giving both patients and health care professionals a good experience in that management process,” King said. “Assuming that the FDA approves Zalviso, we would then look to begin to commercialize in the last quarter of 2014 and into 2015.”
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