FDA Advisory Panel Recommends Collegium’s Xtampza
A joint FDA advisory panel voted unanimously last week to recommend Collegium Pharmaceutical’s Xtampza ER NDA, deciding that the possible risks related to food effects on the opioid’s efficacy were forgiving and not likely to pose serious safety challenges.
This was a marked turnaround from when the same Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee rejected Purdue Pharma’s immediate-release Avridi by a 23-1 vote the previous day on grounds that its abuse-deterrent properties didn’t outweigh the food risks.
Studies of Xtampza (oxycodone) showed significant barriers against common forms of misuse that panelists said take the drug a step in the right direction, including a stinging sensation when the capsule is opened and snorted and a significantly reduced uptake of oxycodone when snorted, versus taken orally and intact. Data also showed the opioid being blocked through IV use, one of the most dangerous abuse forms at risk of overdose.
Though panelists stressed that prescription drugs can’t be abuse-proof by nature, they saw Xtampza as incremental progress. “It’s an opportunity to reduce abuse at the individual level,” said Nananda Col, a temporary voting member and principal of Shared Decision Making Resources in Maine.
FDA officials cautioned that their trial analysis showed the amount of medication entering a patient’s bloodstream is lower under fasting conditions, but increases with fat and calorie content.
“We are concerned with variability in the therapeutic response to the drug and the risks that patients might have resulting from variability,” said Ellen Fields, clinical team leader for several divisions within the FDA.
Collegium conducted tests controlling for meal size that related to around 65,000 doses of the opioid, and representatives said results showed food effects were less clinically relevant because the patient base that would be taking the pain medication has a tolerance to opioids.
They maintained that properties that make it easier for patients with difficulty swallowing to take the pill, thus granting millions access to care they struggle with, also took precedence over any “theoretical” risks.
While panelists felt the link between the food effect and potential efficacy and safety was somewhat unclear, they saw the potential risks as minimal, given appropriate precautions. Less food intake is a more unusual problem than its inverse, so efficacy issues would be rare, they said. And since the product is not an immediate-release, acute medication, it is less likely that patients would take more pills in a short period as pain crops up.
Collegium has agreed to include labeling with the product that would advise the pills be taken with food as part of a larger risk evaluation and mitigation strategy. — Victoria Pelham