New Abuse-Resistant Oxycodone Gets FDA Approval

Yesterday Pfizer, Inc. and Acura Pharmaceuticals, Inc. announced they had received marketing approval from the FDA for Oxecta, a new abuse-resistant formulation of immediate-release oxycodone.   Oxycodone is an opioid analgesic used for the management of both acute and chronic moderate to severe pain.

Oxecta is the first immediate-release oxycodone medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse.   This technology, known as Aversion® Technology, uses a unique composition of commonly used pharmaceutical ingredients that prevent the medicine from being dissolved or crushed for the purpose of abusing them.   Pfizer is licensing the technology in Oxecta from Acura.

In their press release, the companies noted, "Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments. However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives."

Oxecta should not be taken by persons with severe respiratory problems.   The most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, dizziness, loss of strength/energy, and sleepiness.   For more details about important safety information, read the full Oxecta press release.