AcelRx Pharma (ACRX) Announces Positive Data from ARX-04 Phase 3 in Elderly Patients and Patients with Organ Impairment
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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that in an open-label Phase 3 trial (SAP303), investigational product candidate ARX-04 (sufentanil sublingual tablet 30 mcg) was well tolerated in the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment. Regardless of age and organ function, approximately 2 in 3 patients had no adverse events during the study (63% of all patients, 63% of those aged ≥65 years, 62% of those with hepatic impairment, 70% of those with renal impairment). The most common adverse events were nausea and headache. On a global assessment of ARX-04 as a method of pain control, 90% of healthcare professionals and 87% of patients responded "good" or "excellent."
"Following short-stay in-hospital surgery, post-operative patients who do not require long-term analgesia still need safe and effective short-term pain management for efficient discharge," said Pamela Palmer, MD, PhD, co-founder and Chief Medical Officer of AcelRx Pharmaceuticals. "In the SAP303 trial, I was impressed that the majority of patients—including the majority of higher-risk patients—did not experience any adverse events."
SAP303 (NCT02662556) is a multicenter, single-arm, open-label Phase 3 trial that enrolled 140 patients aged ≥40 years who were expected to have moderate-to-severe acute pain after surgery. The primary objective of SAP303 was to study the safety of ARX-04 in the post-operative management of moderate-to-severe acute pain. Recruitment included patients aged ≥65 years and patients with comorbidities.
The mean age for all patients in SAP303 was 54.7 years, and 17% of patients were aged ≥65 years. More than 1 in 4 patients (29%) had some degree of baseline hepatic and/or renal impairment. Nearly 7 in 10 patients (69%) were American Society of Anesthesiologists Physical Status Classification II or III (mild or severe systemic disease). During the 12-hour study period, the mean total number of ARX-04 doses administered was 3.3, which was similar for patients with normal and impaired liver function and for patients with normal and impaired renal function. The mean inter-dosing interval was more than 3 hours (193 minutes).
Safety variables included the assessment of adverse events, vital signs (blood pressure, heart rate, and respiratory rate), and oxygen saturation. The primary efficacy variable was the time-weighted summed pain intensity difference over the 12-hour study period (SPID12), and secondary efficacy variables included pain intensity by evaluation time point.
Safety results showed that, overall, there were no differences in adverse events between patients with normal and impaired liver function or between patients with normal and impaired renal function. No clinically meaningful changes from baseline in vital signs or oxygen saturation were observed, and no opioid reversal agents were needed in the study.
The primary and secondary efficacy endpoints showed a reduction in pain intensity starting at 30 minutes after the first dose of ARX-04, followed by 27%, 49%, and 57% reductions in mean pain intensity from a baseline mean pain score of 6.2 at 1 hour, 2 hours, and 12 hours, respectively.
"Following surgery, and especially following short-stay in-hospital surgery, there is a significant unmet need for an efficacious opioid with good tolerability, particularly in higher-risk patients," said Maurice Jové, MD, who is Medical Director of the Joint Solutions Center at DeKalb Medical and an orthopedic surgeon at Atlanta Knee and Sports Medicine in Decatur, Ga. "ARX-04, if approved, could be the treatment option to meet that need."
Today's announcement marks the completion of the ARX-04 Phase 3 clinical program, which comprises SAP303 and 2 earlier Phase 3 trials in patients with moderate-to-severe acute pain:
- SAP301, an ambulatory surgery study that reported positive results in 2015 at the American Society of Anesthesiologists annual meeting
- SAP302, an emergency room study that reported positive results in 2016 at the Military Health System Research Symposium (MHSRS)
With positive data from all 3 studies, AcelRx intends to submit a new drug application (NDA) for ARX-04 for the treatment of moderate-to-severe acute pain in medically supervised settings with the U.S. Food and Drug Administration (FDA) by the end of 2016.
AcelRx will conduct a conference call and webcast this morning, September 15, at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss the trial results. To listen to the conference call, dial in approximately ten minutes before the scheduled call 877-407-9129 for domestic and Canadian callers, or 201-493-6753 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors section of the company's website at www.acelrx.com. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investors section of the company's website at www.acelrx.com.
Clinical and Rehabilitative Medicine Research Program (CRMRP)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. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries.
In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
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