Orexo believes it is in a position to gain from the decision by Reckitt Benckiser to stop supplying Suboxone (buprenorphine/naxolone) tablets in the US, which currently account for approximately 35 per cent of the US market for treating opioid dependence.
Responding to the decision, Orexo says the discontinued supply of the Suboxone tablets will result in a simplified market situation, as the market will be fully converted to Suboxone sublingual film prior to launch of its Zubsolv product, which is projected for the third quarter of 2013. According to Reckitt, the decision was driven by data showing an increased unintentional paediatric exposure of Suboxone tablets, which are supplied in multi-dose bottles of 30 tablets, compared with the Suboxone film that are individually wrapped in child resistant packages. The decision to discontinue the Suboxone tablet was not linked to any safety signal related to the two active ingredients in Suboxone, namely buprenorphine and naloxone.
As with Suboxone film, Zubsolv will be individually packaged in a child-resistant blister. Neither the Suboxone film nor Zubsolv will be susceptible to direct generic substitution, in the case a potential generic product is approved by the FDA and launched, since both products are protected by intellectual property.
Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste resulting in a strong patient preference of Zubsolv in comparison with Suboxone tablet. The company believes it has the potential to be the first new entrant into a US$1.3 billion market, with more than two million patients suffering from opioid dependence and where a majority of patients are not adequately treated. Market potential for Zubsolv is at peak estimated at US$500 million in sales annually. Zubsolv application for approval was submitted to FDA in September 2012; commercial launch is expected in the third quarter of 2013, subject to FDA approval of the application.