Apr. 22, 2010

A Phase 2 Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of Sublingual Sufentanil NanoTab™ in Patients Following Major Abdominal Surgery


Intravenous patient-controlled analgesia (IV PCA) with morphine is the standard of care in many hospitals for the management of acute post-operative pain. However, IV PCA is associated with several limitations, including, the risk of PCA pump programming errors, reduced patient mobility secondary to the requisite IV line, and increased risk of analgesic gaps due to infiltrated and dislodged IV catheters or pump malfunction. Furthermore, while morphine is the most commonly used analgesic in this treatment modality, it can produce many undesirable side effects due to accumulation of active metabolites, especially in elderly and renally impaired patients.

The Sufentanil NanoTab PCA System is a novel patient-controlled sublingual analgesia (PCSA) product candidate with a pre-programmed patient lock-out feature that is designed for use in hospital settings to provide effective, titratable, patient-controlled analgesia and reduce the risk of programming errors.

The Sufentanil NanoTab PCA System also avoids the IV-related limitations of IV PCA by being designed to provide convenient and safe patient self-administration of Sufentanil NanoTabs sublingually for oral transmucosal absorption. The active drug, sufentanil, is a high therapeutic index opioid approved for intravenous and epidural administration. Although the analgesic efficacy of sufentanil has been well established, its use has been limited due to its short IV plasma half-time.

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