Meda ‘anticipates Onsolis approval’

Meda has forecast that Onsolis – formerly known as Bema Fentanyl, will receive approval from regulatory authorities during the first half of 2009.

The company made this announcement after the US Food and Drug Administration issued a complete response letter for the drug to BioDelivery Sciences International.

It claimed the principle of such a letter is that the regulator accepts the application but is requesting some changes to the risk management programme submitted by the firm

All other aspects of the application were deemed to be complete with no other deficiencies noted by the FDA.

Meda said the request for a risk evaluation and mitigation strategy (REMS) was expected, but not requested by the FDA until after the new drug application in late 2007.

“[It] is believed to be a result of recent experiences with other high-potency opioid products,” the company said.

It added that REMS is a new term for a comprehensive plan and strategy to make sure benefits of new drugs outweigh their risks.

Last month, Meda announced the acquisition to the world-wide rights to four pharmaceutical products from Roche for a total sum of 120 million euros (95 million pounds), equal to around double the annual sales figures for the compounds bought.