FDA delays decision on Collegium's painkiller
- Collegium Pharma's Xtampza, which is intended to be taken after meals for maximum effect, is an abuse-deterrent, extended-release version of oxycodone.
- Last month, an FDA panel recommended the long-acting opioid painkiller, Xtampza, for approval, with a vote of 23 to 0.
- Although it's not been made public why the FDA decided to delay the vote, previously the agency was concerned 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.
Collegium's PDUFA date timing is not fortuitous given the current controversy around opioids. Not only are there 44 overdoses of opioids every day, but two million Americans are actively addicted to these powerful painkillers, according to the World Health Organization. The issue of opioid dependence and overdose has been in the news a lot lately, because of the high-profile, social media-driven activity of Leonard Campanello, the police chief in Gloucester, MA and co-founder of the Police Assisted Addiction Recovery Initiative (PAARI), who has aggressively pushed pharma companies to help address the opioid crisis.
Campanello's efforts are bringing pharma companies to the table to discuss what can be done to address the epidemic, while the FDA continues to seek a balance between caution and availability of effective pain-relief options for the 100 million Americans who live with chronic pain.
It is likely that the FDA's concerns about the need to eat before taking Xtampza could be holding up the process. Part of the problem is the packaging: 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.
Collegium is optimistic that the FDA will make a decision soon and has attempted to assuage the concerns of investors. The stock was down 8% on the news.