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FDA Sends Untitled Letter to Collegium for Extended Release Oxycodone

February 23, 2018

The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in an exhibit booth at an American Society of Health-System Pharmacists meeting last summer.

The agency said Collegium placed risk information for its oxycodone product on a panel several feet away from the main display. In addition, the display in question did not include any information on the risks of addiction or the limited patient population, nor did it include the information in the boxed warning. 

The risk information panel also used much smaller font and no elements indicating it was connected to the main display. The abuse-deterrent characteristics were prominently featured in the main presentation while a caution about other possible abuses was at the bottom.

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