FDA's OPDP Sends First Untitled Letter of 2018

Regulatory NewsRegulatory News | 21 February 2018 |  By 

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) earlier this month sent its first untitled letter of 2018 to Canton, MA-based drugmaker Collegium Pharmaceutical over an exhibit promoting the company's opioid drug Xtampza ER (oxycodone).

In recent years, OPDP has seen a major drop in enforcement letters, culminating in a record low of just five warning and untitled letters sent to Orexigen Therapeutics, Cipher Pharmaceuticals, Magna Pharmaceuticals, Avanthi  and the University of California Los Angeles in 2017.

Untitled Letter

In the letter, FDA says Collegium's exhibit booth for Xtampza ER at the American Society of Health-System Pharmacists' summer 2017 meeting misrepresented the product's risks by placing all risk information on a side panel located several feet away from the principle display.

Xtampza ER is an opioid approved for managing "pain severe enough to require daily, around-the-clock, long-term opioid treatment" and is limited for use in patients who have exhausted other treatment options such as non-opioid analgesics and immediate-release opioids. The drug is also approved for abuse-deterrent label claims for being resistant to manipulation by cutting, crushing, grinding, chewing and dissolving.

However, as with other abuse-deterrent opioid formulations, Xtampza ER's abuse-deterrent properties are only able to deter certain forms of abuse and the drug can still be manipulated and abused through injection, snorting or when taken orally.

Xtampza ER also bears a boxed warning detailing serious risks of addiction, abuse and misuse and contraindications with other drugs such as benzodiazepines and other central nervous system depressants.

"The exhibit booth makes false or misleading representations because it fails to adequately communicate information about the serious risks associated with Xtampza ER use," FDA writes, noting that an OPDP official saw the exhibit in person at the event and that the side panel "utilized a much smaller font size and plain white background, without any visual elements linking it to the principal display panel."

FDA also notes that the issues present in the exhibit are similar to ones FDA addressed in feedback to Collegium in 2016, where OPDP staff recommended the company revise certain presentations for Xtampza ER to ensure they did not misrepresent the drug's risks or approved indication.

"In particular, we cautioned Collegium about failing to present risk information for Xtampza ER with a prominence and readability reasonably comparable to the presentation of benefits. We are concerned that Colleguim is promoting Xtampza ER in a manner that fails to address the very serious risks of the drug, despite this direction from OPDP," FDA writes.

While Collegium included information about the limitations of the drug's abuse-deterrent properties on the exhibit, FDA says that information was placed at the bottom of the display and was "obscured by a table and chair [and] not visible to viewers as a practical matter."



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