Collegium Receives FDA Approval for Xtampza ER, an Analgesic with Abuse-Deterrent Properties

In continuation of my update on oxycodone

Collegium Pharmaceutical, Inc.   announced that the U.S. Food and Drug Administration (FDA) approved Xtampza ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Xtampza ER is Collegium’s first product utilizing its proprietary DETERx® technology platform, and is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation including chewing and crushing the product prior to administration. The Xtampza ER label contains information supporting the administration of the product by sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids. Collegium is committed to supporting responsible, appropriate prescribing for only those patients suffering from chronic pain who don’t have alternative non-opioid treatment options. Xtampza ER will provide clinicians with another treatment option for these patients,” said Michael Heffernan, CEO of Collegium.

MNK-795 for acute pain management: an interview with Dr Lynn Webster

MNK-795 is an investigational, extended-release, oral formulation of oxycodone  (left) and acetaminophen (right) that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. 

MNK-795 is a product in development that is intended to be used for acute pain. It has some unique properties. First, it is an extended release formulation, meaning that it’s going to last more than three to four hours. It was studied to be dosed once every 12 hours, and that is unique for an acute pain formulation.

Secondly, it has abuse deterrent properties which mean that the new design and technology within this formulation may prevent people who try to manipulate, alter or convert the extended release into an immediate release in order to achieve a greater high.

Research has found that when the formulation is manipulated, when it’s crushed in some way or ground up, it actually delays the onset of some of its properties, the liking properties. So rather than causing more liking, more of a high, it actually causes less of a liking and less of a high when it’s manipulated.

This is the first time I’m aware that any technology has delayed and lessened the liking once it’s manipulated. I must, however, stress that at present these are only research results and we cannot yet confirm how MNK-795 will perform in the real world.

MNK-795 for acute pain management: an interview with Dr Lynn Webster