BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the U.S. Food and Drug Administration (FDA) following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.
The discussion with FDA centered on the formation of microscopic crystals and a slight fading of the color during the 24-month shelf life of the product. While these changes do not affect the product's underlying integrity or safety, the FDA believes that the fading of the color in particular may potentially confuse patients, necessitating a modification of the product and product specification before additional product can be manufactured and distributed.
An analysis by BDSI points to these changes being related to a specific excipient used in the manufacturing process that can be removed to resolve the problem. Importantly, the excipient in question is specific to the manufacture of ONSOLIS in the U.S. and is not used in the manufacturing process for BDSI's other products, BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX), where such developments have never been noted. In addition, it is not expected to impact the launch of BREAKYL (brand name for ONSOLIS in E.U.) later this year. BDSI intends to provide further guidance related to timing of resolution of this matter as discussions continue with FDA and additional information becomes available.
"While we are disappointed by this unexpected event, the impact is limited as U.S. sales of ONSOLIS were not yet material to BDSI's operations," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We are confident in our ability to work with our commercial partner, Meda, to make the necessary change to satisfy FDA's concerns. Importantly, while we remain optimistic about the long-term potential of ONSOLIS, BDSI's future value is based on the market potential of two Phase III products, BEMA Buprenorphine for chronic pain, which was recently licensed to Endo Pharmaceuticals for up to $180 million in milestone payments plus royalties, and BEMA Buprenorphine/Naloxone (BNX) for opioid dependence. BEMA Buprenorphine/Naloxone could become the next branded product to compete with Suboxone, which generated sales in 2011 of over $1.2 billion. Neither of these products is impacted by this development."
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