Bema Fentanyl Cheek Film Hits European Market


Twenty-five European countries will have an onsolis-like product on the market soon for breakthrough pain.

Bema Fentanyl was approved in Europe for the treatment of breakthrough pain, in opioid tolerant, adult patients with cancer. The drug is produced by BioDelivery Sciences International, Inc. and Meda.

National marketing authorization approvals are expected over the next several months that would enable commercial sales in 25 individual EU countries.

The prevalence of breakthrough pain in cancer patients with chronic pain is estimated to be between 50% to 66%. It is characterized by intermittent flares of pain that can occur despite treatment with regular analgesic medications, according to The pain tends to occur quickly and may last from seconds to hours. The average duration of breakthrough pain is 30 minutes. Medications for the condition are most effective when they are fast-acting, easily administered, and excreted from the body quickly, the website reads.

BEMA Fentanyl, which is approved in the US and Canada, as Onsolis (fentanyl buccal soluble film), will be marketed as Breakyl (fentanyl buccal film) in Europe.

“We are very pleased to expand the availability of BEMA Fentanyl to include another significant region of the world,” said Dr. Mark A. Sirgo, president and chief executive officer of BDSI, in a press release. “Breakyl is the first product to be approved in the EU using our BEMA drug delivery technology, and we believe it will provide a novel approach to the treatment of breakthrough pain in opioid tolerant patients. The approval of BREAKYL is the result of a continued strong collaborative effort between BDSI and Meda.”

Anders Lönner, chief executive officer of Meda said, “We are pleased with this achievement, and we look forward to making BREAKYL available to patients across Europe who are afflicted with this indication. There is a growing medical need and BREAKYL offers a novel and patented delivery technique compared with current treatment alternatives.”

Bema contains a buccal soluble film that consists of a small bioerodible polymer film. The film is designed to be applied to the inner lining of the cheek, according to the website. The film rapidly delivers a dose of the drug across the mucous membranes for time sensitive conditions.

The film adheres to the membrane in less than five seconds, optimizes drug delivery, and dissolves completely within 15 to 30 minutes.

BDSI develops patented drug delivery technologies. Its two patented drug delivery technologies are Bema and Bioral. Bioral is based on a process of encapsulating a drug to facilitate oral dosing.


Are you currently using an oral soluble film to treat your patient's breakthrough cancer pain? Has the introduction of this technology had an impact on the treatment of breakthrough pain? Leave a comment.

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