Two investigational opioids need to be taken either with or without food
Two FDA advisory committees will meet jointly
this week to evaluate two new abuse-deterrent opioids -- one of them
an immediate-release version, potentially the first of its kind to
incorporate anti-abuse technology.
Most abuse-deterrent formulations have thus far focused on extended-release opioids.
The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will evaluate Purdue Pharma's abuse-deterrent, immediate-release oxycodone (Avridi) on Thursday, Sept. 10 and Collegium Pharma's abuse-deterrent, extended-release oxycodone (Xtampza) on Friday, Sept. 11.
Purdue's Drug
Like other abuse-deterrent opioids, Avridi is shored up against intravenous and intranasal routes, although the immediate-release drug can still be abused orally, the FDA said.
But the bigger issue highlighted by FDA is that the drug appears to be less bioavailable when taken with food -- and for a product that's supposed to be dosed as frequently as every 4 hours, the agency has questioned whether that's possible.
If patients mistakenly dose the drug with food and don't feel pain relief shortly thereafter, they may take more medicine, the FDA said -- potentially leading to a greater risk of overdose.
"Opioid analgesics are generally taken without regard to food, and it is not clear whether labeling would be sufficient to change long-standing behaviors of both prescribers and patients," the agency wrote in a briefing document.
Purdue argues that a label indicating the drug must be taken with food should take care of those concerns.
The company didn't perform any new efficacy studies of the drug. Instead, it is relying on efficacy data from immediate-release oxycodone (Roxicodone) studies done before that formulation's approval in 2000.
Purdue did perform four new safety studies totaling 264 patients.
In addition to questions about abuse deterrence, panelists will also be asked to debate the food and absorption issue, before voting on a recommendation for approval.
Collegium's Drug
On Friday, the two advisory committees will decide whether a fifth abuse-deterrent, extended-release opioid should be on the market.
Collegium's Xtampza uses DETERx technology to prevent abuse via the intravenous and intranasal routes. It's comprised of tiny beads of oxycodone in solution, which are stored in a capsule.
In a press release, the company said it provides label information for patients who have difficulty swallowing to "administer the capsule contents directly into their mouth, sprinkled onto soft food, or via feeding tubes."
But the product is still supposed to be a deterrent against intravenous and intranasal abuse.
Unlike Avridi, Xtampza's bioavailability is increased when taken with food -- as much as five-fold, according to FDA briefing information.
"Fluctuations in oxycodone levels may occur if the product is not taken consistently with the same amount of food," the agency warned.
Collegium argues that label instructions to take their product on an empty stomach should take care of that problem -- but as with Avridi, the FDA notes that opioids are not typically taken with food and it's unclear "if labeling would be sufficient to change long-standing behaviors."
The FDA said it initially advised Collegium to reformulate the product to avoid the food effect, but its final version was still susceptible to increased bioavailability with food, so the agency recommended additional studies to demonstrate safety when taken with food.
Panelists will rely on that data to decide whether Xtampza should be the fifth abuse-deterrent, extended-release opioid approved for marketing.
The four others include three from Purdue -- OxyContin, Targiniq, and Hysingla -- and Pfizer's Embeda.
Most abuse-deterrent formulations have thus far focused on extended-release opioids.
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Both of the investigational opioids have issues with
food; the immediate-release drug becomes less bioavailable with a meal,
while the extended-release version becomes more potent.The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will evaluate Purdue Pharma's abuse-deterrent, immediate-release oxycodone (Avridi) on Thursday, Sept. 10 and Collegium Pharma's abuse-deterrent, extended-release oxycodone (Xtampza) on Friday, Sept. 11.
Purdue's Drug
Like other abuse-deterrent opioids, Avridi is shored up against intravenous and intranasal routes, although the immediate-release drug can still be abused orally, the FDA said.
But the bigger issue highlighted by FDA is that the drug appears to be less bioavailable when taken with food -- and for a product that's supposed to be dosed as frequently as every 4 hours, the agency has questioned whether that's possible.
If patients mistakenly dose the drug with food and don't feel pain relief shortly thereafter, they may take more medicine, the FDA said -- potentially leading to a greater risk of overdose.
"Opioid analgesics are generally taken without regard to food, and it is not clear whether labeling would be sufficient to change long-standing behaviors of both prescribers and patients," the agency wrote in a briefing document.
Purdue argues that a label indicating the drug must be taken with food should take care of those concerns.
The company didn't perform any new efficacy studies of the drug. Instead, it is relying on efficacy data from immediate-release oxycodone (Roxicodone) studies done before that formulation's approval in 2000.
Purdue did perform four new safety studies totaling 264 patients.
In addition to questions about abuse deterrence, panelists will also be asked to debate the food and absorption issue, before voting on a recommendation for approval.
Collegium's Drug
On Friday, the two advisory committees will decide whether a fifth abuse-deterrent, extended-release opioid should be on the market.
Collegium's Xtampza uses DETERx technology to prevent abuse via the intravenous and intranasal routes. It's comprised of tiny beads of oxycodone in solution, which are stored in a capsule.
In a press release, the company said it provides label information for patients who have difficulty swallowing to "administer the capsule contents directly into their mouth, sprinkled onto soft food, or via feeding tubes."
But the product is still supposed to be a deterrent against intravenous and intranasal abuse.
Unlike Avridi, Xtampza's bioavailability is increased when taken with food -- as much as five-fold, according to FDA briefing information.
"Fluctuations in oxycodone levels may occur if the product is not taken consistently with the same amount of food," the agency warned.
Collegium argues that label instructions to take their product on an empty stomach should take care of that problem -- but as with Avridi, the FDA notes that opioids are not typically taken with food and it's unclear "if labeling would be sufficient to change long-standing behaviors."
The FDA said it initially advised Collegium to reformulate the product to avoid the food effect, but its final version was still susceptible to increased bioavailability with food, so the agency recommended additional studies to demonstrate safety when taken with food.
Panelists will rely on that data to decide whether Xtampza should be the fifth abuse-deterrent, extended-release opioid approved for marketing.
The four others include three from Purdue -- OxyContin, Targiniq, and Hysingla -- and Pfizer's Embeda.
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