The results are based on achievement of the primary efficacy endpoint of the trial, Summary of Pain Intensity Difference (SPID), compared to placebo. The results demonstrated that patients treated with BEMA Fentanyl showed a statistically significant improvement on the primary efficacy endpoint at 30 minutes compared to placebo, meaning a greater reduction in pain.
“These phase III results demonstrate that the BEMA delivery system is effective in delivering a significant level of fentanyl over a range of doses to manage the breakthrough cancer pain that occurred in these patients,” said Dr Mark Sirgo, CEO of BDSI.
In 2006, franchise sales for the market leader in rapid acting fentanyl products were a reported $659 million. “We believe that the efficacy and safety profile of BEMA Fentanyl is well suited to penetrate the 90% of the market that is not served by existing products,” commented Dr Sirgo.
BDSI believes that with this treatment it can reach its annual peak sales projection of $250 million for the treatment of breakthrough cancer pain.
Patients from the efficacy study were also eligible for entry in the long-term safety study with BEMA Fentanyl, which is still ongoing. The two studies together will form the foundation of BDSI's new drug application scheduled for submission during the third quarter of 2007.