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Fentanyl Buccal Soluble Film: A Review in Breakthrough Cancer Pain

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Abstract

Fentanyl buccal soluble film (Onsolis®, Breakyl®, Painkyl™) comprises two layers: a mucoadhesive layer containing the active drug, and an inactive layer with the aim of preventing the diffusion of fentanyl into the oral cavity. It is approved in several countries worldwide, including the USA and those of the EU, for the management of breakthrough cancer pain in opioid-tolerant, adult patients with cancer. This article reviews the pharmacological properties of fentanyl buccal soluble film and its clinical efficacy and tolerability in these patients. Fentanyl buccal soluble film provides an additional option for transmucosal delivery of fentanyl, with approximately half of the dose undergoing an initial, rapid absorption via the buccal mucosa (accounting for its high bioavailability). In clinical trials, fentanyl buccal soluble film was associated with significant improvements in pain intensity scores versus placebo and was generally well tolerated. The most common adverse events were typical opioid-associated adverse events, such as nausea and vomiting. Fentanyl buccal soluble film is a useful option for the treatment of breakthrough cancer pain in opioid-tolerant patients.

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Acknowledgments

During the peer review process, the manufacturer of fentanyl buccal soluble film was also offered an opportunity to review this article. Any changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Karly P. Garnock-Jones

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  1. Karly P. Garnock-Jones
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Correspondence to Karly P. Garnock-Jones.

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Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

Karly P. Garnock-Jones is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: D. L. Anghelescu, Division of Anesthesia, St. Jude Children’s Research Hospital, Memphis, TN, USA; D. Taylor, Comprehensive Pain Care, P.C., Marietta, GA, USA.

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Garnock-Jones, K.P. Fentanyl Buccal Soluble Film: A Review in Breakthrough Cancer Pain. Clin Drug Investig 36, 413–419 (2016). https://doi.org/10.1007/s40261-016-0394-y

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