- Despite the fact that Purdue Pharma's latest immediate-release oxycodone formulation is harder to abuse, FDA panelists are worried that patients won't follow dosing instructions for the drug, leading the advisory committee to recommend against the medication's approval.
- The concern is based on the fact that the drug must be taken on an empty stomach in order to be optimally effective, and some patients will not follow instructions.
- The panel voted 23 to 1 against approving the drug. But another opioid painkiller, from Collegium Pharma, received a unanimous recommendation from the panel.
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. In April, the FDA issued new guidelines on abuse-detereent opioids and since then gaining approval for drugs in this class has been more challenging. The new guidance from the FDA focuses heavily on which studies best demonstrate whether an opioid can be considered abuse deterrent—however, the agency emphasizes that fully abuse-proof opioids don't exist.
In fact, Purdue was supposed to appear before the FDA's advisory panel of analgesic experts on July 7 to review data from its supplemental application for abuse-deterrent OxyContin, but chose to delay the meeting. Unfortunately, the panelists weren't convinced that patients could safely take this drug. It's back to the drawing board for Purdue, unless the FDA chooses to approve Purdue's latest oxycodone formulation—which is unlikely as the agency usually follows the panel's recommendations.
On a more positive note, however, an FDA panel has recommended Collegium's opioid painkiller for approval, with a vote of 23 to 0. Xtampza is a long-acting painkillerm which is intended to be taken after a meal for maximum relief.
There is a problem with this medication, too, however: 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. Therefore, even if Xtampza is approved, a package redesign may be in order.