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40 Comprehensive efficacy and integrated safety results from the late-phase clinical program of the sufentanil sublingual tablet 30 MCG
  1. R Leto1,
  2. J Miner2,
  3. Z Rafique3,
  4. M Tyler4
  1. 1University Hospitals of Leuven, Leuven, Belgium
  2. 2Hennepin County Medical Centre
  3. 3Baylor College of Medicine
  4. 4Macksville Hospital, New South Wales, Austrailia


Aim The sufentanil sublingual tablet system (Zalviso) is a non-invasive, patient-controlled analgesia product recently approved in Europe for treatment of acute post-operative pain. A second sufentanil product, a 30 mcg tablet (SST 30 mcg) dispensed sublingually by a healthcare professional, recently completed Phase 3 development for treatment of pain in settings such as the emergency department and EMS. The primary objective of this presentation will be to review key efficacy and safety data from all four late-phase trials.

Methods The late-phase program consisted of two randomised, placebo-controlled studies and two, open-label studies, including one of patients presenting to the emergency department with trauma or injury pain. In all studies there was a minimum re-dosing interval of 60 min and efficacy was assessed using an 11-pt (0–10) NRS. The primary variable was the summed pain intensity difference to baseline (SPID) and safety was evaluated via adverse events (AEs), vital signs and concomitant medications.

Results A total of 479 patients were enrolled; 363 received treatment with SST 30 mcg. In each of the placebo-controlled studies, SST 30 mcg was superior to placebo for the primary efficacy endpoint of SPID12 (p=0.005 and p<0.001, respectively) while the open-label studies demonstrated clinically significant reductions in pain intensity as early as 15 min after dosing. The most commonly reported AEs across all studies were nausea (29%), headache (8%) and vomiting (6%).

Conclusion The sufentanil sublingual tablet 30 mcg, while still under FDA review, has shown potential benefit as a non-invasive analgesic modality in medically supervised settings requiring short-term treatment of acute moderate-to-severe pain.

Conflict of interest Drs. J. Miner and Z. Rafique were principal investigators in the phase 3 clinical trial. Dr. R. Leto and M. Tyler have served as consultants to AcelRx Pharmaceuticals

Funding Development of the Sufentanil Sublingual Tablet 30 mcg 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.

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