Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Cephalon has filed a new drug application with the FDA seeking approval to market OraVescent fentanyl, a tablet for the management of breakthrough pain in patients with cancer who are tolerant to opioid therapy for their underlying persistent pain.
Subscribe to our email newsletter
The tablet delivers the opioid painkiller through the oral mucus membrane utilizing a proprietary enhanced absorption technology.
“Expanding our pain care franchise is integral to Cephalon’s growth strategy,” said Dr Paul Blake, executive vice president of worldwide medical and regulatory operations at Cephalon. “With OVF, we build on our expertise in breakthrough pain to bring innovation to a clinically important, but often inadequately managed, component of chronic pain.”
The new drug application (NDA) submitted for OVF includes results from 13 studies. The pivotal study assessed the safety and efficacy of OVF compared with placebo in opioid-tolerant cancer patients with breakthrough pain. Patients treated with OVF showed a statistically significant improvement in the trial’s primary endpoint, namely the sum of pain intensity differences through 30 minutes (SPID30).
Cephalon intends to commercialize OraVescent fentanyl (OVF) in multiple dosage strengths of 100, 200, 400, 600, and 800 micrograms.