The treatment is developed for patients who are tolerant to opioid therapy for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication. Cephalon expects Fentora to be available in the US during October 2006.
Breakthrough pain is a common component of chronic pain characterized by its rapid onset, intensity, and relatively short duration.
In clinical trials, patients treated with Fentora showed a statistically significant improvement and some patients' experienced significant decreases in pain intensity and greater pain relief within 15 minutes.
“Research on breakthrough pain conducted over the past 15 years suggested that we needed to look beyond conventional short-acting opioids and evaluate new medications that could better manage the rapid onset of this often debilitating condition,” said Russell Portenoy, Chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center. “The clinical trials of Fentora confirm that it is safe and effective for cancer-related breakthrough pain, and may relieve pain faster than orally ingested opioids.”
Conventional short-acting oral opioids, often used to treat breakthrough pain, are swallowed and absorbed in the gastrointestinal tract, which can take up to 30-45 minutes to take effect. With Fentora's drug delivery technology, approximately half of the medicine is absorbed directly across the lining of the upper cheek, and into the bloodstream more quickly than if it were swallowed and broken down by the liver in the gastrointestinal tract.
“Our longer-term clinical strategy is focused on developing Fentora for patients with breakthrough pain associated with other conditions, including neuropathic pain and back pain.” said Frank Baldino Jr, Chairman and CEO of Cephalon.