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Sufentanil sublingual tablets (SST) may be effective for the short-term postoperative or emergency department (ED) management of moderate to severe pain in patients with all body mass index (BMI) levels, according to a study to be presented at the 2018 World Congress on Pain, held September 12-16 in Boston, Massachusetts.
Investigators recently submitted a New Drug Application for SST 30 µg for the treatment, under medical supervision, of acute moderate to severe pain in a postsurgical or ED setting. SST has shown rapid (6 minutes) plasma-central nervous system equilibration time and predictable off-set and uses a noninvasive delivery route, making it appropriate for temporary pain management. This analysis aimed to evaluate all clinical trials regarding the safety and efficacy of SST 30 µg according to BMI subgroups.
A total of 4 late-phase trials examining the efficacy and safety of SST 30 µg were analyzed. Two trials were randomized, placebo-controlled studies examining postsurgical (abdominal and bunionectomy) pain in patients, and the other 2 were single-arm open-label studies investigating the use of SST 30 µg in the ED and postoperatively in elderly patients with multiple comorbidities. Patient-reported pain intensity (evaluated with a 0 to 10 numeric rating scale) was used to assess treatment efficacy, with time-weighted summed pain intensity difference from baseline over 12 hours (SPID12) and 1 hour (SPID1) for the postoperative and ED studies, respectively. Safety was assessed with adverse event (AE) reporting, oxygen saturation values, and vital signs.
A total of 433 patients between the ages of 18 and 84 were included in the study and divided according to their BMI: 275 participants had a BMI <30 kg/m2, 136 participants had a BMI between 30 and 40 kg/m2, and 22 participants had a BMI >40 kg/m2. In the 2 placebo-controlled studies, patients who received SST 30 µg and had a BMI <30 kg/m2 had greater least squares mean SPID12 scores compared with participants given a placebo, and patients with a BMI between 30 and 40 kg/m2 who received SST 30 µg had SPID12 scores that were numerically higher than, but not statistically different from, those who received a placebo. The open-label trials indicated minimal efficacy differences according to BMI subgroup, with mean SPID12 scores of 38.1 and 33.5 in patients with BMI <30 kg/m2 and BMI ≥30 kg/m2, respectively.
Across studies, 50%, 35%, and 32% of patients receiving SST 30 µg reported AEs in the BMI <30 kg/m2, BMI 30 to 40 kg/m2, and BMI >40 kg/m2 subgroups, respectively. The rates of nausea (18%-33%) and headache (5%-10%) — the 2 most frequent AEs in all 3 BMI groups — in patients receiving SST 30 µg did not differ significantly from the rates in those taking placebo.
“While all patients should be monitored closely in postoperative and trauma settings, results from these late-phase studies suggest SST 30 µg is effective and well-tolerated in both obese and non-obese patient populations,” concluded the study authors.
Conflict of Interest Disclosures
Two of the authors are employees of AcelRx Pharmaceuticals, which manufactures sufentanil sublingual tablets.
Hutchins J, Miner J, Minkowitz H, DiDonato K, Palmer P. Safety and efficacy of the sufentanil sublingual tablet 30 mcg by BMI sub-group for the treatment of acute pain in medically supervised settings. Presented at: World Congress on Pain 2018; September 12-16, 2018; Boston, MA. Poster 64096.
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