Company on Target to File Supplemental New Drug Application in the Fourth
FRAZER, Pa., Aug. 16 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a 12-week, Phase 3 clinical trial of FENTORA(R) (fentanyl buccal tablet) [C-II] in patients with breakthrough pain associated with a broad range of chronic non-cancer pain conditions. The study achieved statistical significance on the primary endpoint. Results across the 12 weeks of treatment showed both statistically significant and clinically relevant outcomes for patients with breakthrough pain who were already receiving and who were tolerant to opioid therapy for their underlying persistent pain. FENTORA is approved only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
"We are excited to complete our Phase 3 program with this third and final controlled study. These data show similar positive outcomes as those with FENTORA in treating breakthrough pain in opioid-tolerant patients with cancer, chronic neuropathic pain, and chronic low-back pain," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We plan to submit these data to the Food and Drug Administration in the fourth quarter as part of our supplemental New Drug Application."
About the Study
The double-blind, placebo-controlled, variable dose Phase 3 trial
included 148 patients. The primary endpoint was the Sum of Pain Intensity
Differences from five to 60 minutes (SPID(60)) as assessed after 12 weeks
of treatment. SPID(60) is a measure that assesses analgesic efficacy of a
pain medication over the first 60 minutes after treatment. Patients treated
with FENTORA showed a statistically significant improvement on the primary
endpoint (p<0.0001) compared with placebo. FENTORA was general
|SOURCE Cephalon, Inc.|
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