Positive results have been reported from a phase 3, single-arm, open-label study of sufentanil sublingual tablets, 30 mcg (ARX-04, AcelRx Pharmaceuticals) in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury. The 76 adults treated with sublingual sufentanil experienced a mean reduction in pain intensity of 2.9 from a baseline value of 8.1––a 35% reduction––on a 0-to10 numeric rating scale at 60 minutes.
The trial enrolled patients into two cohorts. The initial phase consisted of 40 adults who were administered a single dose of sublingual sufentanil, and an extension phase enrolled 36 adults who were eligible to receive up to four doses of sublingual sufentanil, administered hourly as needed for pain.
Interim results from the first cohort were reported in February 2016 and showed that patients treated with a single dose of sublingual sufentanil experienced a mean pain intensity reduction from baseline of 2.7 at 60 minutes. Patients in the second cohort reported a mean reduction in pain intensity from baseline of 3.1 on the 0-to-10 pain intensity scale at 60 minutes. Of these 36 patients, seven received a second dose of sublingual sufentanil, and two received a third dose. For 75% of patients in the second cohort, a single dose of sublingual sufentanil was sufficient for pain relief, and only 8% of the patients received morphine in addition to their sufentanil.
Patients reported a mean pain intensity decrease of 1.1 compared with baseline 15 minutes after the first administration of sublingual sufentanil, and a decrease of 1.9 after 30 minutes.
Sublingual sufentanil was well tolerated, with 79% of patients reporting no adverse events. The most common adverse events included nausea (9%), somnolence (5%), and vomiting (4%). All of these events were rated as mild with the exception of one event of moderate nausea. Drug-induced cognitive impairment, as assessed using the validated Six-Item Screener, was not observed.
ARX-04 is a noninvasive investigational product candidate consisting of 30-mcg sufentanil tablets delivered sublingually via a disposable, prefilled, single-dose applicator. ARX 04 is being developed for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including the emergency room, outpatient or ambulatory surgery, nonsurgical patients experiencing pain in the hospital, and postoperative patients who do not require more long-term patient-controlled analgesia after short-stay surgery.
The ARX-04 development program was partly funded by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command. The CRMRP was established in 2008 to support research and technology advances for the regeneration, restoration, and rehabilitation of traumatic injuries.
Source: AcelRx Pharmaceuticals; August 15, 2016.