Data from Pharmawand - Curated by EPG Health - Date added 09 January 2019
AcelRx Pharmaceuticals announced the publication of a pooled analysis in the peer reviewed journal, Pain Management, analyzing the results of AcelRx's clinical studies to assess safety of sufentanil sublingual tablets for the short-term treatment of moderate-to-severe acute pain in medically supervised settings. The objective of the safety analysis was to evaluate the pooled data from AcelRx's clinical studies of sufentanil sublingual tablets (SSTs) administered at 30 mcg dose equivalents over less than 72 hours for moderate-to-severe acute pain management in both postoperative and emergency room patients.
Analysis included a subset of patients from SST 15 mcg studies where patients received the first two doses of SST 15 mcg within the first 20–25 min (representing a 30-mcg dose-equivalent). Overall, 804 patients were evaluated in the pooled safety analysis, including 646 that had received the active drug. Across all of the AcelRx studies, adverse events (AEs) were experienced by 60.5% of patients in the SST group, and 61.4% in the placebo group. The most common treatment-related AEs experienced by patients treated with SST were nausea (28.5%), vomiting (6.5%) and headache (5.0%).
Findings from the pooled analysis support that short-term (less than 72 hours) administration of SST is well tolerated, with most adverse events considered mild or moderate in severity. The publication also noted the additional safety assessment measuring cognitive impairment, which AcelRx had performed in one open-label SST 30 mcg study in emergency room patients (Study SAP302). A total of 75 patients were dosed with SST 30 mcg and evaluated predose and 1 hour postdose for cognitive impairment using the validated Six-item Screener tool. In 97.3% of the patients, the score stayed the same or improved following a dose of SST 30 mcg.
See- "Pooled Phase III safety analysis of sufentanil sublingual tablets for short-term treatment of moderate-to-severe acute pain". James R Miner, Timothy I Melson, David Leiman, Harold S Minkowitz, Yu-Kun Chiang, Karen P DiDonato & Pamela P Palmer Published Online:7 Jan 2019https://doi.org/10.2217/pmt-2018-0090.