The presentation includes results from the previously announced phase 3 results of Zalviso in abdominal patients and the phase 2 results of ARX-04 bunionectomy trial. Both studies were multi-center, randomized, double-blind and placebo-controlled.
Details on the presentation time are as follows:
Thursday, April 16, 2015 – Emerging Technology Poster Session located in the Exhibit Hall - Presentation time 9:00am-4:00pm (local time).
Neil Singla, MD; Harold Minkowitz, MD; Tong-Joo Gan, MD; Yu-kun Chiang, PhD; Karen DiDonato, MSN, RN; Pamela Palmer, MD, PhD
SUBLINGUAL SUFENTANIL FOR THE MANAGEMENT OF ACUTE PAIN
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx's lead product candidate, Zalviso, is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and has submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25th, received a Complete Response Letter from the FDA. AcelRx recently received correspondence from the FDA stating that in addition to the bench testing and two Human Factors studies AcelRx has performed, an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures. AcelRx plans to meet with the FDA to discuss and clarify the need and potential objectives of an additional clinical study for Zalviso. AcelRx has initiated a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting.
The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx's clinical programs, please visit www.acelrx.com.