[Source: Pipeline Review] – INSYS Therapeutics, Inc. announced today the successful completion of the Phase III efficacy clinical trial for its fentanyl sublingual spray product candidate. The product is being developed for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant cancer patients and the Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study. Dose levels of 100 – 1600 mcg were tested in the trial. In the double-blind portion of the trial, patients treated ten episodes of breakthrough cancer pain. The primary efficacy endpoint is Summed Pain Intensity Differences at 30 minutes after dosing (SPID30).
Dr. Richard Rauck, a principal investigator in the Phase III study observed: “Cancer patients suffering significant breakthrough pain found the sublingual (under the tongue) spray of fentanyl produces very fast, effective, and reproducible pain relief. Patients tolerated the spray very well and were extremely pleased with its overall pain-relieving effect and general lack of side effects.”