FDA Approves Extended-Release Oxycodone for Chronic Pain

An oxycodone (Xtampza) extended-release (ER) product is the newest opioid soon to be on the market for chronic pain.

The FDA gave the drug tentative approval late last year, but the agency gave the official green light on April 26. Xtampza ER, developed by Collegium Pharmaceutical, comes in the form of capsules CII and is intended as a twice-daily therapy for severe pain for patients who require around-the-clock treatment.

With the opioid epidemic on the rise, Xtampza utilizes a technology that is designed to prevent the misuse of prescription drugs, DETERx. It maintains the ER property which helps stop people from crushing, chewing, or otherwise manipulating it.

“Abuse-deterrent opioids are critical component to fighting the widespread national epidemic of prescription opioid abuse,” Jeffrey Gudin, MD, director of Pain Management and Palliative Care at Englewood Hospital and Medical Center, said in a news release.

However, the label offers alternative options if a patient has trouble swallowing but wants to take the narcotic.

Xtampza will be available in five dosages with strengths equal to 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg oxycodone hydrochloride. Side effects include gastrointestinal issues, nausea, sleepiness, headache, and abdominal pain.

The medication is expected to be launched for patient use in the United States in mid-2016. For full drug information visit here.