REDWOOD CITY, CA, USA I August 29, 2016 I AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting results from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual tablet, 30 mcg) in 76 patients who were treated for moderate-to-severe acute pain in the emergency department. An oral presentation reviewing these results, including the types of injuries that were sustained by patients in the study, will be made at the International Society for Burn Injuries (ISBI), which is taking place August 29 – September 1 in Miami, Florida.
As previously reported, adult patients treated with ARX-04 in this study experienced a mean pain intensity difference of 2.9 from a baseline of 8.1 on a validated 0 – 10 numeric rating scale at 60 minutes, meeting the study’s primary objective. Injuries sustained by patients in SAP302 included fractures, sprains/strains, lacerations and burns, among others. Study participants tolerated ARX-04 well, with nausea (9%), somnolence (5%) and vomiting (4%) comprising the most commonly reported adverse events.
The study additionally concluded that ARX-04 had no overall impact on cognitive function.
ARX-04 is a non-invasive investigational product candidate consisting of a 30 mcg sufentanil tablet delivered sublingually via a disposable, pre-filled, single-dose applicator (SDA). AcelRx is developing ARX- 04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including the emergency room, outpatient or ambulatory surgery, non-surgical patients experiencing moderate-to-severe acute pain in the hospital, and post-operative patients following short-stay surgery, who do not require more long-term patient-controlled analgesia (PCA).
The ARX-04 Phase 3 clinical program is comprised of three studies in patients with moderate-to-severe acute pain: SAP301, a double-blind, placebo-controlled trial in ambulatory abdominal surgery patients; SAP302, an open-label trial in adult emergency room patients; and SAP303, an open-label trial in postoperative patients. Results of SAP301, which were presented in 2015 at the American Society of Anesthesiologists annual meeting, may be viewed on the AcelRx website.
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046.
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 pain. The Company’s late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) designed for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso® (sufentanil sublingual tablet system) designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has recently completed SAP302 (study in emergency room patients) and SAP303 (study in post-operative patients 40 years and older). Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, AcelRx received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study (IAP312), which AcelRx is planning to initiate once supply testing is complete in order to support its NDA resubmission.
SOURCE: AcelRx Pharmaceuticals