- Collegium Pharmaceuticals Inc. is in hot water with regulators for promoting the benefits more than the risks of its opioid painkiller Xtampza Extended Release.
- Representatives from the Food and Drug Administration noted that, during a conference last summer, Collegium hosted a booth that presented Xtampza ER's positive attributes on a principal display panel. Meanwhile, attributes such as the drug's limitations of use and black box warning were located on a side panel several feet away. The agency also noticed the side panel used smaller font and a plainer background.
- "The exhibit booth presentation made representations and/or suggestions about Xtampza ER but failed to adequately provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety," the FDA's Office of Prescription Drug Promotion (OPDP) wrote in a warning letter dated Feb. 9.
Amid a nationwide opioid epidemic, federal officials have targeted prescription painkillers and the companies that make them.
In June, the FDA took an uncommon step and asked generics and specialty drugmaker Endo International plc to take its opioid-based product Opana ER off the market. Two months later, the Drug Enforcement Agency revealed it was considering instituting a 20% reduction of opioid drug manufacturing in 2018. More recently, the Department of Justice threw its support behind the hundreds of lawsuits that cities and states have lobbed against opioid drugmakers.
Many of those suits revolve around "misleading" or "deceptive" marketing tactics — often meaning a company over-hyped the benefits of their products or downplayed the potential risks for abuse and addiction. Purdue Pharma L.P., the maker of Oxycontin (oxycodone HCl) and a frequently named defendant in opioid marketing litigation, said earlier this month it will no longer promote its now notorious drug to prescribers.
Collegium's Xtampza ER (oxycodone) employs the same active ingredient as Oxycontin. The drug first gained FDA approval in April 2016 to manage severe pain for patients who can't take or don't respond well enough to alternative treatment options. It carries a black box warning for addiction, abuse and misuse, life threatening respiratory depression, Cytochrome P450 3A4 interaction, and several other adverse effects.
Xtampza ER is also Collegium's only marketed product. In the first nine months of 2017, the company recorded $17.7 million in net product revenues.
Also during that period, the OPDP says it gave Collegium advisory guidance about marketing materials the company was planning to use for Xtampza ER. Regulators suggested the materials be revised in a way that would present the drug's risks and benefits with comparable "prominence and readability."
Apparently, Collegium didn't heed the recommendation.
On the primary display panel, for instance, the company highlighted the abuse-deterrent properties of Xtampza ER — like that it keeps its extended-release nature even when crushed, chewed or otherwise manipulated — but didn't detail as clearly that patients can still abuse it.
"While these benefit claims regarding Xtampza ER’s abuse-deterrent properties were prominently presented at eye level and easy to read, material information from the PI regarding the limitation of such properties in preventing abuse was presented at the bottom of the panel near the floor," the FDA wrote in its letter.
Notably, this is the first warning letter from the OPDP published publicly in 2018.