Orexo, a Swedish pharma company, has submitted to the FDA a new drug application for Zubsolv (OX219), its under-the-tongue formulation of buprenorphine and naloxone for treatment of opioid dependence. The drug uses Orexo's sublingual drug delivery technology.
Opioid dependence affects about 2 million Americans, with a huge knock-on cost to healthcare providers, families and society. According to Anders Lundström, Orexo's president and CEO, Zubsolv, expected to launch in the third quarter of 2013, could be the first alternative to Reckitt Benckiser's Suboxone, which had sales of $1.3 billion in 2011. Lundström predicts potential peak sales of $500 million.
"With the NDA submission for Zubsolv (OX219) 5 months ahead of schedule, we will now finalize our U.S. commercialization plans for the brand to ensure that the substantial value of Zubsolv (OX219) will be realized," adds Lundström.
Orexo was formed in 1995, and this is the company's third FDA submission. The company was hit hard earlier this year when it dissolved an agreement with Ortho-McNeil-Janssen Pharmaceuticals and Janssen Pharmaceutica, part of Johnson & Johnson ($JNJ), and cut its 110-strong labor force by up to 35.
- read the press release