Introduction
Opana ER, an extended-release formulation of the opioid oxymorphone, has had a complex and tumultuous history in the pharmaceutical market. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual downfall.
Approval and Initial Success
Opana ER was first approved by the FDA in June 2006 for the management of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment for an extended period[3][4].
- The drug quickly gained traction, becoming Endo Pharmaceuticals' second best-selling drug. By 2009, Opana ER generated $172 million in sales, representing about 12% of Endo’s total annual revenues[3].
Market Growth and Profitability
- Opana ER was highly profitable for Endo, with the company selling the drug at prices far above its cost of manufacturing. The profit margin on Opana ER was substantial, even after accounting for other direct expenses related to selling and marketing the product[3].
- The drug's extended-release formulation provided longer-lasting pain relief, making it a preferred option for patients requiring continuous opioid treatment.
Generic Competition and Anticompetitive Practices
- The threat of generic competition posed significant financial risks for Endo. To mitigate this, Endo engaged in anticompetitive practices. In 2010, Endo agreed to pay Impax Laboratories to abandon its patent challenge and delay entering the market with a generic version of Opana ER until January 2013[3].
- This agreement included a "no-AG commitment," where Endo refrained from offering an authorized generic version of Opana ER during Impax’s initial 180 days of marketing, significantly increasing Impax’s revenues during this period.
Reformulation and Abuse Concerns
- In 2012, Endo introduced a reformulated version of Opana ER designed to be resistant to physical and chemical manipulation for abuse by snorting or injecting. However, this reformulation did not meaningfully reduce abuse and instead led to a shift in the route of abuse from nasal to injection[1].
- The injection abuse of reformulated Opana ER was associated with serious public health consequences, including outbreaks of HIV and hepatitis C, and cases of thrombotic microangiopathy.
Regulatory Actions and Market Removal
- Following a review of postmarketing data and a March 2017 FDA advisory committee meeting, the FDA requested the removal of reformulated Opana ER from the market due to the risks associated with its abuse outweighing its benefits. This was the first time the FDA had taken such action against a currently marketed opioid pain medication[1].
- The FDA’s decision was based on the significant unintended consequences of the reformulated product, including serious disease outbreaks.
Financial Impact of Regulatory Actions
- The removal of Opana ER from the market had a significant financial impact on Endo Pharmaceuticals. The loss of this lucrative product line would decimate a substantial portion of Endo’s revenues, highlighting the risks associated with regulatory actions against high-revenue drugs.
Role of Consulting Firms and Marketing Strategies
- Consulting firms like McKinsey played a significant role in the opioid crisis by advising pharmaceutical companies, including Endo, on aggressive marketing strategies. McKinsey’s efforts, such as "Project Turbocharge," helped Purdue Pharma and other opioid manufacturers to significantly increase their sales despite the mounting human costs[2].
Public Health and Legal Consequences
- The opioid crisis, exacerbated by the aggressive marketing and distribution of drugs like Opana ER, has led to numerous legal actions against pharmaceutical companies and consulting firms. Cities like Seattle have filed complaints against McKinsey for its role in the opioid crisis, seeking to hold the firm responsible for its involvement[2].
Key Takeaways
- Opana ER was a highly profitable drug for Endo Pharmaceuticals but faced significant challenges from generic competition and regulatory actions due to abuse concerns.
- The reformulation of Opana ER failed to reduce abuse and led to serious public health consequences.
- The FDA’s decision to remove Opana ER from the market marked a significant shift in regulatory approaches to opioid medications.
- Consulting firms like McKinsey played a critical role in the opioid crisis through their aggressive marketing strategies.
FAQs
What was the primary reason for the FDA's decision to remove Opana ER from the market?
The FDA requested the removal of Opana ER due to the risks associated with its abuse, particularly the shift to injection abuse, which led to serious disease outbreaks such as HIV and hepatitis C[1].
How did Endo Pharmaceuticals respond to the threat of generic competition for Opana ER?
Endo agreed to pay Impax Laboratories to abandon its patent challenge and delay entering the market with a generic version of Opana ER, ensuring a period of exclusivity for Impax and maintaining high revenues for Endo[3].
What was the impact of McKinsey's "Project Turbocharge" on opioid sales?
McKinsey's "Project Turbocharge" significantly increased opioid sales for companies like Purdue Pharma by targeting high-prescribing physicians and reworking incentive programs, despite the mounting human costs of the opioid crisis[2].
How profitable was Opana ER for Endo Pharmaceuticals?
Opana ER was highly profitable, with sales reaching $172 million in 2009 and representing about 12% of Endo’s total annual revenues. The profit margin on Opana ER was substantial, even after accounting for other direct expenses[3].
What were the public health consequences of the reformulated Opana ER?
The reformulated Opana ER led to serious public health consequences, including outbreaks of HIV and hepatitis C, and cases of thrombotic microangiopathy due to injection abuse[1].
Sources
- FDA requests removal of Opana ER for risks related to abuse - FDA
- SeattleMcKinseyComplaint2022 - Seattle.gov
- Impax Laboratories Administrative Complaint - FTC
- Opana ER Drug Monograph - Mass.gov
