Cephalon step further for full Fentora approval

Cephalon has announced that it has made an important step towards full Fentora approval today, having a received an approvable letter from the FDA. The letter follows a submission of a new drug application in August last year, calling for Fentora to be released on the drug market.

Fentora is designed to manage breakthrough pain ? a rapid onset, intense kind of pain that is a common component of chronic pain. Around 50 million people suffer from the condition in America alone, which is characterised by its relative intensity when compared to stable consistent pain.

Cephalon suggests Fentora, an orally administered agent, can be used to manage the pain thought OraVescent technology, which “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”.

This allows for “rapid and efficient” delivery of the drug directly to the bloodstream. Clinical studies showed Fentora significantly decreased pain intensity for cancer sufferers, with phase III trials showing the drug was well-tolerated.

Dr Paul Blake, executive vice president of worldwide medical and regulatory operations, commented on the approvable letter recently gained by the company.

He said: “We are pleased with FDA’s response and are working closely with the agency to secure final approval of this important new medication. 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.”

Current treatments for chronic pain include acupuncture, local electrical stimulation and brain stimulation, according the National Institute of Neurological Disorders and Stroke (NINDS). Placebos have also been effective in the treatment of the condition, states the NINDS.

© Adfero Ltd