Opana ER is the brand name of the specific extended release preparation of oxymorphone HCL marketed by Endo Pharmaceuticals, Inc. This was the drug of choice that underlay the explosion of opioid addiction and of HIV/AIDS and hepatitis infections in intravenous users in nearby Scott County, Indiana. Opana is back in the news, but not in a good way for Endo. The FDA assembled an expert review panel last week to opine on whether the benefits of Opana ER outweighed its risk to its users. The short summary of its findings and recommendations is that the benefits do not outweigh the risks, and that the drug’s continued marketing should be controlled in a variety of possible ways including removal from the market, or restrictions on who can prescribe it and under what conditions.
To summarize the findings of the article below, Opana ER is not a big player in the prescription opioid market in any event. Its active ingredient, oxymorphone, is manufactured or distributed in the US by at least 19 different companies but fills less than 1% of opioid prescriptions. (I must admit up front that have no idea who actually makes what pills or where the active ingredient in the various preparations comes from.) A detailed list of individual versions of oxymorphone by NDC from the labelers below is available here. (or here as Excel file.) It occurs to me as I see such long lists of labeler names, that with so many ways for a drug to enter the community, opportunities for diversion from supervised distribution become correspondingly more numerous. Given all the apparent distributors, is it even possible for an Endo or a Mallinckrodt to know where the drugs they might manufacture end up? Mallinckrodt in particular has been accused of not keeping very good track at all, at least in Florida. Continue reading “FDA Panel Finds Opana-ER Not Worth The Risk!”