REDWOOD CITY, Calif.
Oct. 15, 2013
/PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced presentations of its previously reported Phase 3 data for Zalviso™ (sufentanil sublingual microtablet system) at several major medical meetings in
and the United States. Scheduled for presentation during the European Federation of IASP Chapters (EFIC) Annual Congress held in
October 9-12, 2013
and at the American Society of Anesthesiologists (ASA) meeting in
being held on
October 12-16, 2013
, this is the first time data from the Phase 3 study of Zalviso in the treatment of post-operative pain in patients after knee or hip replacement surgery will be presented at a major medical meeting. In addition, data from other Phase 3 Zalviso clinical studies will also be presented at these medical meetings. Zalviso is a patient-activated, non-invasive analgesic system, which delivers 15 mcg sufentanil per dose sublingually as needed for pain control, subject to a 20-minute lockout period between doses.
"Presentations at important medical meetings in both the EU and US of favorable Phase 3 data for Zalviso represent an opportunity for investigators to discuss the trials and their impressions of Zalviso with other thought leaders in the pain-treatment community," stated
, president and CEO of AcelRx. "Presentations of this data are an important step in the familiarization of the medical community with Zalviso, and in enabling early understanding of the potential value the product may provide to their patients, if approved by the regulatory agencies."
The Phase 3 orthopedic study data presented at these meetings were from a trial that enrolled 426 patients to evaluate the ability of Zalviso to control pain during the 48-hours immediately following knee or hip replacement surgery, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (SPID-48), compared to a placebo-treated group of patients. Results demonstrated that patients receiving Zalviso realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs. -11.5, p<0.001). Secondary endpoint data showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 in each case). Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events.