Orexo spins OX219 up to speed
Uppsala – Backed by strong clinical research, the development of Orexo AB’s drug candidate OX219 for treatment of opioid dependence is gathering momentum. A clinical Phase I study was carried out to decide the commercial formulation and dose for the active ingredients buprenorphine and naloxone. While buphrenorphine is known to be effective against withdrawal symptoms and blocks the “high” effects of other opioids, naloxone counteracts the “high” effect that may arise following the intravenous injection of a dissolved tablet.
After FDA consultations, Orexo has decided to apply for a final drug development and registration path according to the 505(b)(2) application process. This enables regulatory clearance based on documentation from an already approved drug, in this case Suboxone®. That would allow Orexo to obtain approval without costly clinical efficacy and safety studies, and thus lead to a much faster route to market. The Swedish drugmaker will use its proprietary sublingual technology to dispense OX219. Orexo says that means previously acquired technology worth some SEK38m will be written off in Q3/2011, but that this decision will have no impact on the company’s liquid assets.
Clinical development of OX219 is being pursued in the US, which is the main market for current market leader Suboxone. The global market for products for the treatment of opiate dependence is currently estimated at US$1.4bn. OX219 is one of the three development programmes that Orexo intends to take all the way to market launch on its own. All of them are based on previously-known substances that Orexo has reformulated using the sublingual route of administration.