New Schedule II Opioids Introduced

Released: 05/04/2016   By: Heidi Dufrene, Pharm.D.

Oxaydo™, a Schedule II opioid, is the first and only immediate-release formulation of Oxycodone HCL that discourages intranasal abuse and is indicated for the management of acute and chronic moderate to severe pain, where the use of an opioid analgesic is appropriate. The tablets contain sodium lauryl sulfate, which may cause nasal burning and throat irritation when snorted. However, there is no sufficient evidence that Oxaydo™ has reduced abuse liability compared to immediate-release Oxycodone. If no risk of intranasal abuse is present, a generic form of Oxycodone is preferred. Currently, Oxaydo™ is available in 5mg and 7.5mg tablets.

Xtampza ERTM is a new Schedule II opioid from Collegium Pharmaceuticals that recently received FDA approval on April 26, 2016, and is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Xtampza ER uses Collegium’s proprietary DETERx technology, which provides abuse deterrent properties if subjected to manipulation such as chewing and crushing prior to administration. The capsules may be opened and sprinkled onto soft foods or administered through a gastrostomy or nasogastric tube for feeding, without losing its abuse deterrent properties. Xtampza ER will be available as 9mg, 13.5mg, 18mg, 27mg, and 36mg capsules. The anticipated release is mid-2016.

According to the FDA, current abuse deterrent technology does not prevent all methods of abuse. Current Official Disability Guidelines (ODG) state that neither Oxaydo™ nor Xtampza are recommended as first-line therapy, but may be recommended for select patients with risk of abuse that has been documented. Both medications are considered an “N” drug on the ODG formulary, which means they are not preferred by the ODG organization to initially treat patients.