Patient-Controlled Analgesia System Enters Phase III Trials

An analgesia system delivering small doses of the opioid sufentanil may represent significant progress for patient-controlled analgesia devices, according to a Pain Medicine News report.

Designed by AcelRx Pharmaceuticals, the Sufentanil NanoTab PCA System delivers 15-mcg sublingual sufentanil tablets from a cartridge that is locked inside a pre-programmed, handheld controller operated by the patient. A lockout period between doses prevents the patient from taking tablets within 20 minutes of each other.

The new system involves a better device, a better route of delivery and a better drug than traditional IV patient-controlled analgesia, according to Pamela P. Palmer, MD, chief medical officer of AcelRx. Morphine has a narrow therapeutic index and carries the side effect of sedation, which can lead to the potentially serious consequences of shallow breathing and oxygen desaturation in older patients, she said. In contrast, sufentanil has a very high therapeutic index.

The Sufentanil NanoTab PCA System will enter Phase III trials this year. Phase I studies confirmed that it provides lower peak plasma levels and a longer-lasting plasma concentration than IV administration. Phase II studies found a low incidence of sedation.

Related Articles on Pain Management:

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Dr. Scott Glaser: 3 Concept in Interventional Pain Management to Reduce Hospitalization

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