FDA Statement: Original Opana ER Relisting Determination
The U.S. Food and Drug Administration (FDA) today responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.
The petition was submitted by Endo Pharmaceuticals Inc., the sponsor of original Opana ER and a reformulated version, also called Opana ER, which was designed with the goal of being more difficult to abuse and misuse. After an extensive, science-based review, FDA concluded based on the available data and information that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, FDA has denied the manufacturer’s petition.
FDA conclusions include:
While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.
Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
The postmarketing investigations are inconclusive, and even if one were to treat available data as a reliable indicator of abuse rates, one of these investigations also suggests the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.
FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce prescription drug abuse and to positively affect public health. FDA reviews every application on its own merits, based on applicable scientific and legal standards. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. Abuse-deterrent properties must be supported by sound science taking into consideration the totality of the data for the particular drug at issue.
Abuse deterrent formulations are an important tool to help address misuse of medication. In addition, both prescriber and patient education is vital to safe and effective opioid use. FDA encourages all opioid prescribers to take advantage of valuable training, available as of March 1, 2013, to help ensure they have adequate and up-to-date training in opioid therapy. FDA urges all prescribers to ensure patients using opioids are appropriately informed of the risks and benefits of these drugs and fully understand directions for their use. The opioid drug labeling also provides prescriber information related to patient education.