Endo International is reviewing a request from the US Food & Drug Administration (FDA) to remove the opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market. The government body's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committee concluded Opana ER's benefits no longer outweigh the risk of its abuse and misuse.
Opana ER is an opioid agonist indicated for the management of severe pain. In a statement, Endo noted there were no questions over the safety and efficacy of the medication when taken as prescribed. The FDA's decision to request the removal of the drug from pharmacies was down to concerns over improper use and abuse of the medication. It is the first time the agency moved to remove an opioid pain medication from the market due to the problems associated with abuse.
The drug first gained FDA approval in 2006, then in 2012 it was reformulated to increase resistance to chemical and physical manipulation. This was to discourage abuse of the prescription medication and to make it harder to extract the active ingredients, discouraging snorting or injecting. Despite this, the FDA refused a request to include labeling about the potentially abuse-deterrent properties of Opana ER.
FDA Commissioner Scott Gottlieb, MD, stated: "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse." He highlighted the importance of the FDA's role in reducing opioid misuse in the United States, describing the scale of the problem as an "epidemic".
The FDA cited data showing a change in the route of abuse of Opana ER, with the reformulated version more commonly injected rather than snorted. This has been linked to a "serious outbreak of HIV and hepatitis C as well as cases of serious blood disorder," it asserted. The FDA claims the request for the removal of Opana ER from the market will protect the public from further misuse of the medication. Should Endo choose not to comply with the request, the FDA warned formal steps would be taken to withdraw its approval.
Endo responded to the announcement saying it was "reviewing the request and is evaluating the full range of potential options" as they determine the best course of action to take. However, it also expressed confidence in the clinical research into the drug, claiming the evidence shows Opana ER has a "favorable risk-benefit profile" when used correctly in appropriate patients.
Another company developing abuse-deterring opioid medication is Inspiron Delivery Sciences, which earlier this year gained FDA approval for its immediate-release RoxyBond (oxycodone hydrochloride). Every year, nearly 18 million prescriptions for immediate-release oxycodone hydrochloride are filled in the United States. RoxyBond is the first and only immediate-release opioid with abuse-deterring properties to gain approval from the FDA. The medication forms a viscous material resistant to injection and includes physicochemical properties expected to reduce intranasal abuse.
