FDA Approves First ER Oxycodone Acetaminophen Combo

FDAThe US Food and Drug Administration (FDA) has approved an extended-release combination of oxycodone and acetaminophen (Xartemis XR, Mallinckrodt plc), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment, and for patients for whom alternative treatment options are ineffective, not tolerated, or would otherwise be inadequate.

The drug has both immediate- and extended-release components to allow pain relief within an hour, with twice-daily dosing, the company notes in a statement issued today.

Approval is based in part on results of a phase 3 trial in an acute post-surgical pain model of bunionectomy; results were presented last fall during PAINWeek 2013, and reported by Medscape Medical News at that time. The new formulation met the primary endpoint and showed statistically significant improvement in pain scores vs placebo from baseline over 48 hours.

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FDA tightens Opiod Labeling to stress the dangers of its long term use!

opioidsThe FDA has ordered a class-wide label change for long-acting opioids such as OxyContin (oxycodone) aimed at limiting use of these drugs to patients with severe, refractory pain.

The move, announced at press briefing Tuesday, is part of a handful of changes that the agency hopes will curb an ongoing prescription painkiller epidemic, including a label clarification about the risks of abuse and death with the drugs, a requirement for additional postmarketing studies, and a boxed warning about the risks of neonatal opioid withdrawal syndrome.

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Tighten Opioid Label Restrictions, Physicians Tell FDA

A coalition of 37 physicians that includes pain management and addiction experts petitionedthe US Food and Drug Administration (FDA) yesterday to tighten label restrictions for opioid analgesics as a way to combat the epidemic of addiction and fatal overdoses associated with these drugs.

Under the proposed label changes, opioids would no longer be indicated for moderate noncancer pain. The petition notes that moderate to severe pain is the FDA-approved indication for nearly all instant-release opioids as well as extended-release versions when 24/7 pain relief is needed for a long stretch of time. Such “overly broad indications” imply that the FDA has established that long-term use of opioids is safe and effective, the petition states. “An increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses.” [Read more…]