If anybody is cheering for a quick and painless approval of extended-release opioid Exalgo (hydromorphone hydrochloride), it has to be the former owners of Neuromed, the privately held company that held the rights to the drug and merged into CombinatoRx. Approval of the chronic pain medication, with an upcoming PDUFA date of February 22, guarantees that the pre-merger owners of Neuromed will own 60% of the shares in the combined company, a proportion that will decline should the approval process drag on (CombinatoRx finds that reversing is the way forward, July 3, 2009).

Given the tough attitude the FDA has taken towards pain medications and their potential for abuse, further delays are within the realm of possibility, even probability. The approval date has already been delayed since November 22, with the company stating that the agency needed more time to review the application. But the market and analysts are taking the view that approval is the most likely outcome, and with it, a $30m milestone payment from Mallinckrodt, the Covidien subsidiary that will commercialise the drug.