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Positive Phase III Results With Sublingual Sufentanil in Management of Postoperative Pain
Sublingual NanoTabs reduce pain intensity in third pivotal study (May 21)
The primary efficacy endpoint has been achieved in a placebo-controlled phase III trial of sublingual sufentanil (Sufentanil NanoTab PCA [patient-controlled analgesia] System; AcelRx Pharmaceuticals). The study evaluated the control of pain intensity compared with baseline during a 48-hour period immediately following major orthopedic surgery (i.e., knee or hip replacement), using the FDA-requested primary endpoint of the Summed Pain Intensity Difference to baseline (SPID-48).
The results showed that patients receiving sufentanil NanoTabs achieved a significantly greater SPID-48 during the study period compared with placebo-treated patients (+76.1 vs. –11.5; P < 0.001). Secondary endpoint data also showed that the SPID at 24 hours and 72 hours was significantly greater in sufentanil-treated patients than in placebo-treated patients (P < 0.001 in each case).
The randomized, double-blind, placebo-controlled study evaluated 419 adult patients with moderate-to-severe acute pain immediately following major orthopedic surgery. The patients were treated for a minimum of 48 hours, and up to 72 hours, with sublingual sufentanil (n = 315) or placebo (n = 104). Both treatments were delivered by the patient, as needed, using the NanoTab system, with a 20-minute lock-out period. Patients in both groups could receive up to 2 mg of intravenous (IV) morphine per hour as a rescue medication.
This study was the last of three successful phase III trials conducted by the drug’s developer (AcelRx) to support U.S. regulatory review of the sufentanil NanoTab PCA system. In November 2012, the company announced positive results for the NanoTab system in a phase III open-label, active-comparator study that evaluated the efficacy and safety of the NanoTab system compared with IV PCA with morphine in the management of moderate-to-severe acute pain after surgery. In this trial, the NanoTab system met its primary endpoint of non-inferiority to IV PCA with morphine at 48 hours in the patient global assessment (PGA).
In addition, in March 2013 the company announced positive results from a randomized, double-blind, placebo-controlled, pivotal phase III study that evaluated the ability of sublingual sufentanil delivered by the NanoTab system to control moderate-to-severe acute pain after major abdominal surgery compared with placebo. Patients receiving sufentanil NanoTabs achieved a significantly greater SPID-48 during the study period compared with placebo-treated patients.
Source: AcelRx Pharmaceuticals; May 21, 2013.