AcelRx: Presentation of Investigator-Initiated Trial Results

 Brigham and Women's Hospital study found that SST-treated patients had significantly lower pain scores in the post-operative care unit (PACU) compared with patients in the two intravenous opioid control groups following major spine surgery

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the results of a 190-patient, investigator-initiated trial conducted at Brigham and Women's Hospital in Boston, MA, entitled, "The Impact of Sublingual Sufentanil on Postoperative Pain Control in Patients Undergoing Spine Surgery" (abstract # A4262), was presented at the ANESTHESIOLOGY® 2022 annual meeting, held October 21-25, 2022 in New Orleans, LA. The study found that patients who underwent major spine surgery had significantly lower reported postoperative pain scores when treated with sufentanil sublingual tablet (SST), 30 mcg (DSUVIA®) versus intravenous (IV) opioids.

The senior author of the study was Richard Urman M.D., Associate Professor and Founding Co-Director, Center for Perioperative Research, Department of Anesthesiology at Brigham and Women's Hospital. The study was an Institutional Review Board (IRB)-approved, prospective trial comparing an SST-treated cohort (n=30) with a two-arm (n=80 each) historical matched control. Study inclusion criteria consisted of patients 18 years or older undergoing spine surgery (up to 3 levels) and a planned inpatient stay.  Both the prospective arm and two retrospective control arms received standard general anesthetic, except the prospective SST arm received intraoperative sufentanil IV infusion and an initial dose of SST immediately following extubation.  SST was re-dosed as needed, no more than hourly, in the postoperative care unit (PACU) for numeric rating scale (NRS) pain scores of greater than 3 out of 10. Hydromorphone IV bolus was used for breakthrough pain not controlled by SST. Control Arm 1 received intraoperative remifentanil IV infusion and Control Arm 2 received intraoperative sufentanil IV infusion and both received hydromorphone IV bolus as the primary analgesic in the PACU as needed for NRS scores of greater than 3. A multi-variable linear regression adjustment and an inverse probability of treatment weighting was used to measure the effectiveness of SST in decreasing postoperative pain scores in the PACU as the primary outcome.

A total of 190 patients were analyzed and demographics were relatively similar among the groups. As a result of the linear regression model, adjusting for age, sex, BMI, ASA classification, surgical invasiveness, and medication history, the authors found that patients in the study group who received SST experienced statistically significantly lower pain scores in the PACU compared with the two IV opioid control groups (p<0.001). The SST group had a mean ± standard deviation NRS score of 3.2 ± 2.4, whereas the remifentanil/hydromorphone group averaged an NRS score of 5.7 ± 2.2 and the sufentanil/hydromorphone group averaged an NRS score of 5.0 ± 2.4.

The authors concluded that use of SST appears to be an effective alternative analgesic therapy in spine surgery patients who experience moderate to severe postoperative pain resulting in improved pain scores in the PACU, and, that further analysis of the data will examine the impact on postoperative opioid consumption and hospital length of stay.

https://www.biospace.com/article/releases/acelrx-pharmaceuticals-announces-presentation-of-investigator-initiated-trial-results-comparing-acelrx-s-sufentanil-sublingual-tablet-sst-versus-intravenous-opioids-for-postoperative-pain-at-the-anesthesiology-annual-meeting-2022/