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news.Collegium Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Xtampza ER (oxycodone), a novel, abuse-deterrent, extended-release oxycodone formulation for the treatment of chronic pain.
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Xtampza ER is an opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are not adequate.
It uses the company’s DETERx technology platform, and is designed to maintain its extended-release profile after being subjected to common methods of tampering.
The product’s label features data 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 via a gastrostomy or nasogastric feeding tube.
The abuse-deterrent properties incorporated into the Xtampza ER formulation are designed to make it more difficult to manipulate for the purpose of abuse or misuse through common routes of administration including chewing, crushing and/or dissolving, and then taking orally, snorting, or injecting, Collegium said.
Collegium Pharmaceutical CEO Michael Heffernan said: "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."
The company intends to launch Xtampza ER in the US in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone hydrochloride.