AcelRx initiates IAP312 Phase 3 trial for study of Zalviso

AcelRx Pharmaceuticals has commenced with its IAP312 Phase 3 trial for the study of Zalviso, its new investigational product in development to treat moderate-to-severe acute pain in adult hospital patients.

"Anecdotal experience from Grunenthal's Zalviso launch that began in April has been favorable, with patients and healthcare workers providing positive feedback on the pain control offered by sublingual sufentanil," AcelRx CEO Howie Rosen said. "We look forward to conducting the IAP312 study and submitting the findings to the FDA so that they may consider the product for approval here in the U.S. We will provide an update on study duration once we are further along with enrollment."

Chief Medical Officer Dr. Pamela Palmer said AcelRx designed Zalviso to have characteristics that would offer patients and health care providers benefits over IV morphine, the current standard of care for the treatment of moderate-to-severe acute pain in hospitalized patients.

"The initiation of IAP312 is an important milestone, as it represents what we expect to be the last step in the Zalviso clinical development program, bringing a product that we believe can offer patients a new option for treating their moderate-to-severe acute pain, closer to market," Palmer said.