Cephalon, Inc, an international biopharmaceutical company, has received an approvable letter from the US Food and Drug Administration (FDA) for Fentora (fentanyl buccal tablet) [C-II].
The company submitted a new drug application (NDA) in August 2005, seeking to market Fentora for the treatment of breakthrough pain in opioid-tolerant patients with cancer.
"We are pleased with FDA's response and working closely with the agency to secure final approval of this important new medication," said Dr Paul Blake, executive vice president, Worldwide Medical and Regulatory Operations. "We believe Fentora, will extend the leadership position of Cephalon in the development of innovative medications for the management of breakthrough pain in patients with cancer."
Fentora is specifically designed, to manage breakthrough pain, a common component of chronic pain that can be characterized by its intensity, rapid onset, and relatively short duration. The medication is a simple-to administer sugar free, fentanyl buccal tablet that can be discretely placed between a patient's upper cheek and gum.
Its proprietary, OraVescent technology uses an effervescent reaction to produce transient shifts in pH levels in the area surrounding the tablet which is thought to enhance the rate and extent of fentanyl absorption through the buccal mucosa. The OraVescent technology permits rapid and efficient delivery of the majority of the medication directly into the bloodstream.
The NDA submission, for Fentora included data from 13 clinical studies. Fentora in adult patients with breakthrough pain who were already receiving opioid medication for treatment of their moderate to severe cancer pain. In the pivotal study, Fentora provided clinically significant decreases in pain intensity and greater pain relief in as little as 15 minutes.
The phase 3 safety and efficacy studies demonstrate that, Fentora was generally well tolerated. The most common adverse effects observed were typical of those seen with opioids and in patients with cancer being treated with chemotherapy, including nausea, dizziness, headache, fatigue, vomiting, and somnolence.
The company currently markets five proprietary products in the United States: Provigil (modafinil) Tablets [C-IV], Gabitril (tiagabine hydrochloride), Actiq (oral transmucosal fentanyl citrate) [C-II], Trisenox (arsenic trioxide) injection, Vivitrol (naltrexone for extended-release injectable suspension) and numerous products internationally.