Stymied at FDA, AcelRx claims success with PhIII pain study

Days after the FDA reiterated its demand for a new trial of AcelRx's ($ACRX) pain drug Zalviso before it can reconsider a marketing application, the small biotech says it has garnered positive data from its late-stage study of another pain remedy in the pipeline. The Redwood City, CA-based biotech says that the sublingual sufentanil tablet ARX-04 met the primary and secondary endpoints set out for patients with moderate-to-severe acute pain following ambulatory abdominal surgery. AcelRx has had a credibility issue with investors, having to renege on its promise to make a quick U-turn to the FDA after regulators rejected Zalviso last year. Now the biotech is suggesting that it's closer to a green light for another program. "These results bring AcelRx one step closer to commercializing a sublingual sufentanil product that we believe will have a meaningful impact by providing a non-invasive treatment of moderate-to-severe acute pain in several medically supervised settings," said Pamela Palmer, the founder and chief medical officer of AcelRx Pharmaceuticals. Release

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.