Plans to relaunch breakthrough cancer pain treatment Onsolis are now delayed indefinitely until BioDelivery Sciences International (NASDAQ:BDSI) can work out manufacturing issues raised by the U.S. Food and Drug Administration.
Over Onsolis’ two-year shelf life, the product’s pink appearance can fade. The FDA told the Raleigh, North Carolina company that the color change could confuse patients and the agency is directing BDSI to make formulation changes.
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“They’re strictly related to the appearance of the product,” BDSI vice president of marketing Al Medwar said of the changes. “There’s no efficacy or safety issue.”
Onsolis that is currently on the market can continue to be used for cancer patients. But until the company can meet with the FDA to further discuss the matter, no new product will be made or shipped. Medwar said that there is no time line for restarting Onsolis manufacturing.
Onsolis, approved by the FDA in 2009, employs BDSI’s drug-delivery technology to administer medication quickly via a small piece of dissolvable film placed on the inside of the cheek. Onsolis delivers the painkiller fentanyl. But although Onsolis has been approved for the U.S. market for nearly three years, its sales so far have been limited. Onsolis is available only under a Risk Evaluation and Mitigation Strategy, or REMS. These FDA guidelines were required of certain products that carry health risks or the potential for drug abuse. While BDSI was required to comply with REMS requirements, similar fentanyl products commercialized by other companies prior to the REMS requirement continued to market their products without those restrictions and put BDSI at a competitive disadvantage. The FDA last year established a class-wide REMS for all fentanyl products to take effect in March and BDSI planned an Onsolis relaunch to coincide with change.
The FDA raised its Onsolis concerns following a recent inspection of the Aveva Drug Delivery Systems manufacturing facility where Onsolis is made. It’s not the first time that an Aveva inspection has delayed Onsolis manufacturing. In 2010, the contract drug manufacturer voluntarily shut down manufacturing at its Maitland, Florida plant while it responded to concerns raised in an FDA warning letter. While the Aveva problems were not related to Onsolis, the plant shutdown effectively delayed the product’s launch in Canada.
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Onsolis is now available in Canada and Sirgo said that regulators there have not raised concerns about the product’s change in appearance. Medwar said the color change is due to an excipient, one of the inactive ingredients used in making the product. That ingredient will be removed. The color change is not expected to be an issue in BDSI’s other product candidates because they do not use that ingredient. BDSI also does not expect the manufacturing issue will delay European launch this year of Breakyl, the brand name for Onsolis in the European Union. Breakyl will be made by a different manufacturer.
[Photo courtesy of BioDelivery Sciences International]
Carissa Maree Greider
