King Pharmaceuticals 'pursues abuse-deterrent label'
20 Jan 2009
A leading pharmaceuticals firm has been pressing the US Food and Drug Administration (FDA) to introduce a new category to describe one of its products.
King Pharmaceuticals (KP) is looking to use the term "abuse-deterrent" to describe Remoxy, a pain drug it claims is less likely to be used recreationally than popular medications Oxycontin and Percocet, Legal View reports.
The drug is a modified version of oxycodone, a chemical compound used in these, but this version is a time-release gel capsule its manufacturer claims is less suited for abuse.
In order to obtain this label, the FDA says KP will need to present out non-clinical data such as studies and surveys among users, the news provider reveals.
Oxycodone-based medicine currently available on the market presents a number of drug safety issues due its high addictiveness and rates of abuse.
In other news, the FDA has announced it will not be able to complete a review of Takeda Pharmaceutical Company's New Drug Application for febuxostat in time to meet the deadline set by the Prescription Drug User Fee Act date.
