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.
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