Novel Sufentanil Tablet System Non-Inferior to Intravenous Analgesia

the MPR take:

Intravenous patient-controlled analgesia (IV PCA) has earned higher patient satisfaction compared to nurse-administered analgesics, but the risk of infections, analgesic gaps from to catheter infiltration or IV tubing obstructions, and prescribing and programming errors can lead to complications or mortality. Particularly with morphine, IV PCA dosing can result in delayed adverse events such has respiratory depression. A novel sufentanil sublingual tablet system (SSTS) (15mcg dose), stored bedside and preprogrammed with a 20-minute lockout interval and a radio-frequency identification (RFID) thumb tag that only allows the patient to operate the device, was studied in a Phase 3 open-label, active comparator study to IV PCA morphine sulfate (IV PCA MS) 1mg dose with a 6-minute lockout for 48 hours post-elective major open abdominal or orthopedic surgery. In a total of 357 patients, 78.5% responded “good” or “excellent” (collectively “success”) at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48) with SSTS vs. 65.6% with IV PCA MS. Patients using SSTS reported more rapid onset of analgesia, as well as higher patient and nurse ease of care and satisfaction scores. A New Drug Application (NDA) was submitted for the SSTS in September 2013 and accepted in December 2013.

Novel Sufentanil Tablet System Non-Inferior to Intravenous Analgesia
Novel Sufentanil Tablet System Non-Inferior to Intravenous Analgesia

Intravenous patient-controlled analgesia (IV PCA) has been utilized for over 40 years to allow hospitalized patients to self-titrate opioids to relieve moderate-to-severe acute pain. While the patient-controlled aspect of this approach achieves higher patient satisfaction than nurse-administered analgesics, many issues continue to plague IV PCA

READ FULL ARTICLE From Wiley Online Library