FDA concerned about dosing risk with Collegium's opioid painkiller
- The FDA is currently reviewing Collegium's Xtampza, an ER formulation of oxycodone with a built-in abuse-deterrrence feature.
- Unlike most opioid painkillers, Xtampza, which is under FDA review, should be taken after eating to maximize effectiveness. The review committee has flagged this as a safety concern for potential addiction and abuse.
- The FDA's concern is that if a patient takes Xtampza without eating, there may not be sufficient pain relief---which could lead the patient to overdose in an attempt to acheive sufficient relief.
Prescription opioid abuse is an epidemic in the U.S., according to the Centers for Disease Control and Prevention (CDC).The CDC estimates that 44 people per day in the U.S. die as a result of overdoses.
Collegium designed Xtampza with a built-in abuse-deterrence feature based on proprietary technology. Because of this feature, Xtampza cannot be crushed and snorted, nor can it be melted and injected.
The problem, however, is not lack of abuse deterrence, but how Xtampza is packaged. Although there are explicit instructions on the label warning patients that Xtampza must be taken with food, Xtampza is packaged in 100-count bottles. The FDA has warned that inevitably some patients will never see the instructions.
At this point, the FDA has not made a package redesign an approval condition for Xtampza. However, the agency has concluded that Collegium needs to rethink package design, assuming an approval is forthcoming. A decision is expected by October 12.