FDA accepts NDA from Mallinckrodt for combo pain medication
- FDA has accepted Mallinckrodt’s NDA for Xartemis (oxycodone/acetaminophen).
- Xartemis is intended to be used for the treatment of moderate to moderately severe pain when opoid treatment is appropriate.
- Mallinckrodt presented safety and efficacy data at the American Pain Society Meeting in Tampa in early May.
Mallinckrodt developed Xartemis (oxycodone/acetaminophen) for the treatment of moderate to moderately severe pain for situations when a non-opioid treatment is not sufficient to address the pain. This is the first and only oxycodone/acetaminophen combination for acute pain with both immediate and extended-release formulations.
Earlier in May, the company presented data at the American Pain Society meeting highlighting the pharmacokinetics and safety profile of Xartemis.