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news.Lab International's lead product Fentanyl Taifun, an inhaled painkiller, has posted positive results in a phase II trial evaluating the drug in breakthrough cancer pain.
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The multi-centered, placebo-controlled, parallel group trial was undertaken to establish formal dose response data of Fentanyl Taifun, with primary efficacy endpoints being the time to significant pain relief and the degree of pain relief.
Fentanyl Taifun was administered at doses of 100, 200, and 400 micrograms per dose during two episodes of breakthrough pain with rescue medication available upon request. A total of 122 cancer patients on maintenance opioid therapy for persistent pain were enrolled in the trial.
Time to significant pain relief was achieved on average in 7.8 to 11.6 minutes, depending on the dose. The difference to placebo was statistically significant with the 100 micrograms and 400 micrograms doses of Fentanyl Taifun. However, the 200 micrograms results were not statistically significant.
“Our product has been demonstrated to provide instantaneous availability of fentanyl in the blood within one minute after inhalation and may provide more rapid pain relief than any existing non-injectable pain medication, as demonstrated by the time to significant pain relief. The speed of analgesia with Fentanyl Taifun is approaching the theoretical minimum of 3-5 minutes observed with intravenous administration of fentanyl,” said Dr Halvor Jaeger, CEO of Lab International.