Unlike most opioid painkillers, which are either taken on an empty stomach or without regard for food intake, users must take Xtampza after eating to release the maximum effects. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain.
The Food and Drug Administration (FDA) issued a warning for an experimental form of the painkilling drug oxycodone, which has been marketed as Xtampza by Massachusetts-based Collegium. The FDA accepted Collegium’s application for the drug in February, and it remains under review. Xtampza is unique among oxycondone painkillers due to Collegium’s anti-abuse proprietary technology. The drug, which is a long-lasting opioid that is taken in oral form, cannot be crushed and snorted, nor can it be melted down for injection. As my colleague Jay Belle Isle referenced earlier in the week, addiction and abuse concerns involving painkillers rand high among members of the FDA, as well as others in the healthcare community. According to the U.S. Center for Disease Control and Prevention, opioid abuse has been labeled as an “epidemic” since 2011, killing roughly 44 people per day. Xtampza is Collegium lead experimental drug in its growing developmental portfolio of pain medications with anti-abuse features.
Wednesday’s press release concerns the dosing and packaging of the drug. Unlike most opioid painkillers, which are either taken on an empty stomach or without regard for food intake, users must take Xtampza after eating to release the maximum effects. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain. The warning comes a day after an FDA panel flagged another opioid medication marketed as Avridi from Purdue Pharmaceuticals, which is required to be taken on an empty stomach, for similar reasons. Although representatives for Collegium had proposed adding a label on the drug that clearly states it should be taken after eating, the FDA believes that Xtampza’s packaging does not provide a visible enough warning.
The panel stopped short of requiring a packaging redesign as a condition of approval. That may change however; after an FDA advisory panel of experts meets on Friday to decide whether or not to recommend Xtampza for the agency’s approval. Although the FDA is not mandated to heed recommendations made by the expert panel, it does so on most occasions. Collegium is planning on selling Xtampza in bottles of 100, with staff at the FDA staff believing that many users will inevitably fail to see the instructions on the bottle. The agency did urge Collegium to reassess the effectiveness of its packaging for the drug. Friday’s FDA panel will review evidence and clinical studies to determine if the risks outweigh the benefits for Xtampza. The FDA announced that it should have a final ruling on the drug’s approval by October 12th.
BioPharma Dive – Nicole Gray
International Business Times –Guneet Bhatia
Reuters – Samantha Kareen Nair and Natalie Grover