FDA approves Collegium’s Xtampza ER, an oxycodone version that deters abuse

The FDA approved Collegium Pharmaceutical’s ($COLL) version of the painkiller oxycodone that features properties that will deter the drug’s abuse.

Dubbed Xtampza ER, the compound used Collegium’s DETERx microsphere-in-capsule technology that is designed to provide pain control while maintaining its drug profile even if it is crushed or chewed, a common form of drug abuse manipulation. Xtampza ER is an extended-release capsule taken twice daily by patients suffering from levels of pain requiring around-the-clock, long-term opioid treatment, the company said.

Additionally, the new formulation allows patients to sprinkle the contents of the capsule on soft foods or in liquids. It can also be ingested through a gastrostomy or nasogastric feeding tube.

“Abuse-deterrent opioids are a critical component to fighting the widespread national epidemic of prescription opioid abuse,” Dr. Jeffrey Gudin, director of pain management and palliative care at Englewood Hospital and Medical Center, said in a statement. “The FDA approval of Xtampza ER is incredibly timely as abuse and misuse of opioids is at an all-time high.”

The company plans a U.S. launch of the drug by midyear in 5 different dosage strengths equivalent to oxycodone hydrochloride.

- check out Collegium’s release 

- read about Pfizer's abuse-deterring opioid candidate here