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SAFETY AND EFFICACY OF SUFENTANIL SUBLINGUAL 30MCG TABLETS BY SURGERY TYPE FOR THE TREATMENT OF ACUTE PAIN FOLLOWING OUTPATIENT ABDOMINAL SURGERY
ESRA Academy. DIDONATO K. Sep 8, 2016; 138504; 0364 Topic: PAIN THERAPY (ACUTE - CHRONIC)
Disclosure(s): I am an employee of AcelRx Pharmaceuticals
Karen DIDONATO
Karen DIDONATO

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Abstract
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Background and Aims:

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 (SST30) dispensed by a healthcare professional, is in Phase 3 development for treatment of moderate-to-severe pain in medically-supervised settings.  The primary objective of this study was to compare the efficacy and safety of SST30 to placebo (PT) for management of acute pain following typical outpatient abdominal surgeries.

Methods:

The study was randomized and placebo-controlled for up to 48 hours in adult patients undergoing abdominoplasty, open tension-free inguinal hernioplasty or laparoscopic abdominal surgery. Efficacy was assessed by patient reports of pain intensity on an 11-point numerical rating scale. Primary efficacy variable was the summed pain intensity difference to baseline over the 12-hour study period (SPID12).  Safety assessments included vital signs, adverse events (AEs) and concomitant medications.

Results:

A total of 161 (107 SST30 and 54 PT) patients were randomized and received study drug.  Average patient age was 41 years; 68% were female. Statistically significant SPID12 differences were observed in favor of SST30 over PT (25.8 vs. 13.1; p<0.001).  Subgroup analysis by surgery type also yielded higher scores for SST30 over PT; abdominoplasty (30.8 vs 17.6), hernioplasty (18.6 vs 7.7) and laparoscopic abdominal (21.4 vs 8.2).  Nausea, headache and vomiting were the most common AEs across both treatment arms.

Conclusions:

SST30 has shown benefit over placebo across a range of surgical procedures as a non-invasive analgesic modality for short-term treatment of acute moderate-to-severe pain.

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