FDA approved Xtampza ER (oxycodone) for Severe Persistent PainFDA approved new long acting painkiller Xtampza ER for severe pain

Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action is not known, but it is believed to be related to the presence of opioid receptors in the central nervous system.

Xtampza ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. It is not indicated as an as-needed (prn) analgesic. Due to risks of addiction, abuse, misuse, overdose, and death, reserve Xtampza ER for patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Xtampza ER should be prescribed only by healthcare professionals knowledgeable about extended-release/long-acting opioids and how to mitigate associated risks. Use the lowest effective dose for the shortest duration. For patients not opioid-tolerant, initiate with 9 mg (equivalent to 10 mg oxycodone HCl) every 12 hours. Single doses greater than 36 mg or total daily doses greater than 72 mg are only for opioid-tolerant patients. Opioid-tolerant patients are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone HCl per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Xtampza ER must be taken with food; instruct patients to take with approximately the same amount of food for every dose. Capsules can be sprinkled on soft foods or administered via gastrostomy or nasogastric tube. Maximum daily dose is 288 mg (equivalent to 320 mg oxycodone HCl). For hepatic impairment, initiate at 1/3 to 1/2 usual dosage and titrate carefully. Do not abruptly discontinue in physically dependent patients.

Trial data not available in label.

Warnings include risks of addiction, abuse, misuse, overdose, and death; respiratory depression; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; severe hypotension; and risks in patients with gastrointestinal obstruction. Contraindications include significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment, known or suspected gastrointestinal obstruction (including paralytic ileus), and hypersensitivity to oxycodone.

Xtampza ER is an extended-release opioid reserved for patients with severe persistent pain who have inadequate response to alternative options. It should be used as part of a comprehensive pain management plan, with careful patient selection, monitoring for adverse effects, and consideration of risks of misuse and dependence.