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Home > Pharmacy News >Drug Approvals > Approval of Fentora Buccal Tablet

The U.S. Food and Drug Administration approved Fentora® (Fentanyl Buccal tablet, Opioid derivative) for management of breakthrough pain in cancer patients, which is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain. Breakthrough pain can reach peak intensity in as little as three minutes and typically lasts for 30 to 60 minutes.

 

Fentora is sugar-free and simple to administer as it can be discretely placed between a patient's upper cheek and gum (buccal cavity).

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 approval of Fentora was based on 13 clinical studies. The pivotal* double-blind, placebo-controlled, variable-dose study assessed the safety and efficacy of 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 most serious adverse events associated with all Opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock.

Fentora is manufactured by Cephalon, Inc

*Pivotal study: A study, usually Phase III, that presents the data used by FDA to decide whether to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.

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