PA experts observing the recent marketing withdrawal of Opana ER (oxymorphone hydrochloride) considered other data that could be examined to determine if there is something inherent to the formulation that encourages more dangerous avenues of abuse, and the impact of other external factors on real-world safety.
On July 6, Endo Pharmaceuticals announced it would withdraw Opana ER from the market. This followed a March meeting of FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees in which committee members voted 18 to eight that the benefits of the formulation no longer outweigh the risks. Opana ER has been implicated in outbreaks of a Thrombotic Thrombocytopenic Purpura (TTP)-like illness in northeastern Tennessee and an HIV outbreak in southern Indiana. While Opana ER was not approved for labeling as abuse deterrent, Endo’s marketing of the product referenced the product’s formulation with Grunenthal’s INTAC® Technology which was intended to create a crush resistant product.
In the case of Opana ER, we note that other external factors potentially impacting the severity of the TTP and HIV outbreaks may have included how the drug was prepared for injection, other drugs injected with it, a shortage of syringes, criminal penalties (Indiana only) for possession of syringes, and lack of access to methadone/buprenorphine treatment.
Based on the publicly available information on Opana ER, companies may want to consider the following:
- Completing all abuse potential studies requested by the FDA
- Conducting heat pretreatment studies, with appropriate comparators
- Collecting and analyzing geographic-specific post-marketing surveillance data, including the collection of baseline data
- Conducting thorough surveillance, including field research, in the localities affected, to determine external factors potentially impacting these public health issues
PA scientists and experts prepare preliminary abuse potential assessments to determine gaps in the abuse potential assessment program, develop protocols for laboratory assessment of the abuse characteristics of product formulations, and develop and execute postmarketing surveillance, including field research.
Note: PA did not provide support to Endo on Opana ER development, abuse potential assessment, or regulatory strategy.