520 Fentanyl TAIFUN

Fentanyl TAIFUN was developed for treatment of breakthrough cancer pain. When compared with other dosage forms used for the treatment of breakthrough pain, the inhalation route offers greater convenience and a more rapid onset of pain relief. 

The results support clinical efficacy already at the lowest dose of 100 pg and a trend of dose-response relationship. The safety of Fentanyl TAIFUN was similar to that of placebo, with the exception of an increase in mild to moderate somnolence. The TAIFUN metered inhaler is depicted in Figure 111.4. 

The multi-centered, randomized, double-blind, placebo-controlled, parallel group trial of 122 cancer patients on maintenance opioid therapy was undertaken to establish formal dose-response data of Fentanyl TAIFUN . The primary variables were the time to significant pain relief and the degree of pain relief. Fentanyl TAIFUN was administered at doses of 100, 200, and 400 pg per dose during two episodes of breakthrough pain with rescue medication available upon request. 

Prehminary data suggest positive results from the open-label arm of its Fentanyl TAIFUN phase Ilb clinical trial. The results from 24 patients demonstrated successfiil dose titration resulting in effective control of breakthrough pain episodes. 

All 24 patients were successfully titrated to a dose of 400 pg or less. From these first 24 patients, nine patients titrated to 100 pg, ten patients titrated to 200 pg and only five patients titrated to 400 pg. The patients experienced significant pain relief in 95% of the pain episodes treated. The estimate of the median time to significant pain relief was 7 minutes. Based on the interim adverse event data, Fentanyl TAIFUN doses have been well tolerated and adverse events recorded were in accordance with previously disclosed Fentanyl TAIFUN clinical trial data, therefore suggesting high tolerabihty of Fentanyl TAIFUN in opioid-tolerant cancer patients. 

Figure 111.4. The TAIFUN metered-dose intrapulmonary fentanyl Inhaler.

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