Extended-Release Oxycodone/Acetaminophen: Overview of a Novel Opioid

CPA reports on a new analgesic formulation designed to provide both immediate and prolonged analgesia for up to 12 hours in patients with acute pain.

In 2014, the US Food and Drug Administration approved the first and only extended-release (ER) formulation of oral oxycodone HCl and acetaminophen (Xartemis XR, made by Mallinkrodt, Inc).

Previously known as MNK-795, the product is designed to provide both immediate and prolonged analgesia for up to 12 hours in patients with acute pain. It is intended for use in patients for whom alternative treatments are ineffective, not tolerated, or otherwise inadequate.

In a review published in the Journal of Pain Research, Mary Bekhit, MD, from UCLA David Geffen School of Medicine in Los Angeles, CA, discusses the pharmacological properties, clinical utility, contraindications and patient considerations associated with ER oxycodone and acetaminophen (APAP) combination therapy.

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“Despite the abundance of opioids available for treatment of acute pain, as well as the large variety of dif­ferent classes of analgesics in addition to the opioid family, many patients still frequently experience undertreated acute pain,” Dr. Bekhit points out, noting a need for new therapeutic alternatives.

ER oxycodone/acetaminophen expands the armamentarium for treating acute pain by offering a dual benefit over previously available immediate-release (IR) analgesics: a prolonged duration of action, and multimodal analgesia through combination of an opioid and nonopioid component, Dr. Bekhit writes.