Orexo, an emerging specialty pharmaceutical company, has submited a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

The development of Zubsolv (OX219), a product based on Orexo’s proprietary sublingual drug delivery technology, has progressed well and faster than originally anticipated. A total of four clinical studies were completed in support of the filing, along with a CMC product stability program covering two independent manufacturing sites.

“Today´s FDA submission, the third in our short history, constitutes a substantial milestone,” said Anders Lundström, CEO of Orexo. “Very few companies of our size and lifetime have ever managed to complete three development programs, Edluar, Abstral and now Zubsolv. Orexo will potentially be the first company to offer an alternative treatment option to Suboxone, which reached sales of $1.3 billion in 2011 and continues to exhibit steady growth of more than 15% annually.”

Lundström continued, “The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013—ahead of other branded competitors.

The Zubsolv treatment option will, once approved by the FDA, be directed towards the authorized specialized prescribers of Suboxone in U.S., of which 5,000 physicians account for about 90% of all U.S. prescriptions.

“In our clinical studies Zubsolv has demonstrated an accelerated dissolve time, has a smaller tablet size and an improved taste, resulting in a strong preference in comparison with the Suboxone tablet,” said Lundström. “Our market insights indicate that these properties, which are important product characteristics for particularly sublingual therapies, will be important drivers for the market uptake of the product and we estimate peak sales to reach $500 million annually.”  

The NDA submission for Zubsolv was five months ahead of schedule. Orexo will now finalize its U.S. commercialization plans for the brand.