Sweden’s Meda and partners are celebrating the news that regulators in the USA have approved their product to treat pain in cancer patients.

The US Food and Drug Administration has approved Onsolis, a small dissolvable disc that delivers fentanyl to the buccal (inner lining of cheek) membranes. The product is indicated for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy.

Anders Lonner, Meda’s chief executive, said that “the interest among specialists for this new technology is significant, and we are making preparations for product launch during the fourth quarter”. He added that the introduction of Onsolis in the USA “has high priority for us, and we are well positioned to be successful”, noting that its registration in other key markets is “progressing according to plan”.

Onsolis is made by Aveva Drug Delivery Systems and marketed by Meda under a licence from BioDelivery Sciences International. The approval has triggered a $12 million payment from the Swedish firm to the latter company.

The medication can provide strong pain relief to patients who are opioid tolerant, but for those who are not, “it can lead to overdose, sudden serious breathing difficulties and death,” said Bob Rappaport, director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, As such, Onsolis should be prescribed only under the safeguards provided by the FDA-required risk evaluation and mitigation strategy developed by Meda and BDSI “and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications,” Dr Rappaport said.