Mallinckrodt’s SpecGx division has announced the rejection of its abuse-deterrent re-formulation of opioid analgesic Roxicodone by the US Food and Drug Administration (FDA).
Pfizer’s Troxyca ER has been approved in the US for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.