FDA takes deep dive into opioid APIs
The FDA has given unwavering attention the last few years to the quality of active pharmaceutical ingredients (APIs). Now it intends to do some research on very specific APIs, those used in opioids.
According to Pharmafile, the FDA wants someone to look very closely at the APIs, as well as excipients, and the technology used to manufacture opioid pain drugs to see what will make them tamper-resistant. According to an FDA solicitation that kicks off the process, the research is to "investigate the effect of physicochemical properties of the active and excipients and composition of the drug product, along with the drug product manufacturing technology on the manipulation of the drug product for extraction of the active ingredient for putative abuse."
The research is an adjustment to the FDA's guidance from January on formulating and manufacturing tamper-resistant opioid pain drugs. That document sets out what the agency is thinking about studies from companies going that route. The FDA has been under mounting pressure to take the lead in finding ways to make opioids more difficult for addicts to abuse. In the guidance, the FDA said that while opioid analgesics are important to modern pain management, their abuse has created "a serious and growing public health problem." Pharmafile points out that the Centers for Disease Control and Prevention (CDC) published a report recently that opioid abuse grew fourfold among women and two-and-a-half fold among men between 1999 and 2010.
In April the FDA took the unusual step of banning any generics of the original long-acting formulation of the best-known drug in the category, OxyContin. It said the danger of abuse outweighed the benefits of a cheaper version of the product. It also, for the first time, gave OxyContin maker Purdue Pharma the right to put a specific claim on its new version of the drug that it is abuse-deterrent.
So now the FDA wants data on what works and what doesn't in terms of creating an abuse-deterrent drug. That will help it evaluate the generics or new drugs that could come up for approval. Actavis ($ACT), having settled a patent fight with Purdue in April, has said it will seek approval of an abuse-deterrent generic of the drug.