FDA/CDC

Endo removes Opana ER from market


 

Even as it defended the product’s safety when appropriately used, Endo International withdrew from the market its long-acting opioid agonist Opana ER, in compliance with a June 8 Food and Drug Administration request. The company “continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the company has taken significant steps over the years to combat misuse and abuse,” according to a news release posted on Endo’s website. “Nevertheless, after careful consideration and consultation with the FDA following [its] June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”

FDA made the request in the wake of an upsurge in abuse of the medication, which began after a 2012 reformulation of the drug. Ironically, the reformulation was an antiabuse move, intended to make Opana ER resistant to the chemical and physical changes necessary for snorting or injecting the drug. But postmarketing data did not support the company’s claim that the new formula would “meaningfully reduce abuse.”

In fact, the data showed a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a thrombotic microangiopathy.

Endo said it will work with FDA to coordinate a smooth removal of the product, and insisted that the drug is safe and effective.

“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”

Opana ER was first approved in 2006 for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012, with the intent of making it “resistant to physical and chemical manipulation for abuse by snorting or injecting,” according to the FDA release.

msullivan@frontlinemedcom.com

Recommended Reading

10 tips to mitigate legal risks of opioid prescribing
MDedge Rheumatology
Pediatric psoriasis linked to multiple psychiatric comorbidities
MDedge Rheumatology
Latest CDC data: Opioid deaths still rising
MDedge Rheumatology
VIDEO: Compassionate care, decriminalization crucial to mitigating addiction epidemic
MDedge Rheumatology
Evidence for medical marijuana largely up in smoke
MDedge Rheumatology
Mortality rate was 10-fold higher in opioid use disorder patients
MDedge Rheumatology
FDA asks drug maker to shelve Opana ER
MDedge Rheumatology
For opioid-related hospitalizations, men and women are equal
MDedge Rheumatology
Follow five tips to mitigate opioid prescribing risks
MDedge Rheumatology
New on the streets: Drug for nerve pain boosts high for opioid abusers
MDedge Rheumatology