Sufentanil sublingual formulation for the treatment of acute, moderate to severe postoperative pain in adult patients.

INTRODUCTION: Sufentanil is a highly selective µ-opioid agonist commonly used by intravenous and intrathecal routes for acute pain. Sublingual sufentanil formulation for patient controlled analgesia (PCA) uses an innovative administration device that suspends a 15 µg nanotablet with a fixed lockout interval. The system is a non-invasive, less burdensome method of opioid delivery compared to intravenous and intrathecal routes. Sublingual nanotablet PCA transmucosal bioavailability is 59% and the meaningful analgesic onset time is 60 minutes. Areas covered: This paper focuses on the effectiveness, safety and feasibility of sufentanil PCA sublingual formulation for the management of postoperative pain. The paper is based on PubMed searches and the European Medicine Agency assessment report. Expert commentary: Under-treatment of acute pain is a substantial clinical problem. The initial experiences with the sublingual delivery system are encouraging. Sufentanil sublingual nanotablets intended for PCA device use are approved in Europe, and approval is pending in the United States.