Introduction to Zohydro ER
Zohydro ER (hydrocodone bitartrate) is an extended-release (ER) opioid medication approved by the FDA for the management of severe, chronic pain that requires around-the-clock, long-term treatment and for which alternative treatments are inadequate. It is a single-entity hydrocodone product, which means it does not contain acetaminophen, reducing the risk of severe liver damage associated with acetaminophen-containing products[1].
Market Positioning
Zohydro ER is positioned as an alternative to other opioid medications, particularly for patients who are already on opioid therapy. The FDA has clarified that Zohydro ER is not intended to increase the number of patients treated with opioids but rather to provide another option for prescribers. This means that Zohydro ER is expected to capture a share of the existing opioid market rather than expanding it[1].
Sales Organization and Strategy
Pernix Therapeutics, the company behind Zohydro ER, has undertaken significant strategic changes to focus on this product. In 2018, Pernix reorganized its sales force into 74 sales territories, primarily focusing on Zohydro ER and another product, Silenor. This reorganization was aimed at maximizing the long-term growth potential of Zohydro ER, leveraging its strong intellectual property portfolio and lengthy exclusivity period. The company anticipated annualized cost savings of $7-$8 million from this realignment[2].
Availability and Dosage Options
Zohydro ER is available in various strengths, including 10mg, 15mg, 30mg, 40mg, and 50mg, which align with the morphine milligram equivalents recommended by the Centers for Disease Control and Prevention (CDC) for chronic pain management. However, there have been temporary stockouts, such as the 20mg strength being on back order until the first quarter of 2018 due to manufacturing issues. Despite these challenges, the other strengths have continued to be marketed and distributed, ensuring a wide range of dosage options for patients[5].
Sales Projections and Financial Impact
The reorganization and focus on Zohydro ER were part of Pernix Therapeutics' strategy to enhance financial flexibility and drive growth. The company expected increased usage of Zohydro ER, along with other core products, to contribute to future revenue growth and profitability. The cost savings from the reorganization were also intended to support potential future acquisitions and product opportunities[2].
Market Challenges and Opportunities
One of the significant challenges for Zohydro ER is the ongoing scrutiny and regulatory environment surrounding opioid medications. The FDA requires post-market studies to assess the risks of misuse, abuse, addiction, overdose, and death associated with long-term use of ER/LA opioids like Zohydro ER. This ongoing monitoring can impact public perception and prescribing practices[1].
However, the opioid market remains substantial, and the need for effective pain management solutions continues. For instance, the global opioid-induced constipation market, which is closely related to the opioid therapy market, is projected to grow at a CAGR of 4.76% from 2023 to 2033, reaching a value of USD 2.15 billion by 2033[3].
Competitive Landscape
Zohydro ER competes in a crowded opioid market, but its unique positioning as a single-entity hydrocodone product without acetaminophen offers a distinct advantage. The development of abuse-deterrent technologies, although still in its early stages, is a priority for the FDA and could further differentiate Zohydro ER in the market[1].
Clinical Efficacy and Safety
Clinical studies have demonstrated the efficacy of Zohydro ER in reducing chronic pain. The drug has shown superiority over placebo in reducing average daily pain intensity scores and has been supported by various secondary endpoints such as Subject Global Assessment of Medication and Worst Pain Intensity[4].
Conclusion
Zohydro ER is a significant player in the opioid market, particularly for the management of severe, chronic pain. With its unique formulation, wide range of dosage options, and strategic focus by Pernix Therapeutics, the drug is well-positioned for continued market presence. However, it must navigate the complex regulatory and public health landscape surrounding opioid use.
Key Takeaways
- Market Positioning: Zohydro ER is designed to capture a share of the existing opioid market rather than expanding it.
- Sales Strategy: Pernix Therapeutics has reorganized its sales force to focus on Zohydro ER and Silenor, anticipating cost savings and growth.
- Dosage Options: Available in various strengths, aligning with CDC guidelines for chronic pain management.
- Financial Impact: Expected to contribute to revenue growth and profitability, with cost savings supporting future opportunities.
- Market Challenges: Ongoing regulatory scrutiny and public health concerns surrounding opioid use.
- Clinical Efficacy: Demonstrated effectiveness in reducing chronic pain in clinical studies.
FAQs
Q: What is Zohydro ER used for?
Zohydro ER is used for the management of severe, chronic pain that requires around-the-clock, long-term treatment and for which alternative treatments are inadequate.
Q: What is unique about Zohydro ER compared to other opioid medications?
Zohydro ER is a single-entity hydrocodone product, meaning it does not contain acetaminophen, which reduces the risk of severe liver damage.
Q: How has Pernix Therapeutics strategized to promote Zohydro ER?
Pernix Therapeutics has reorganized its sales force to focus on Zohydro ER and Silenor, aiming to maximize long-term growth potential and reduce costs.
Q: What are the available dosage strengths of Zohydro ER?
Zohydro ER is available in 10mg, 15mg, 30mg, 40mg, and 50mg strengths, aligning with CDC guidelines for chronic pain management.
Q: What are the potential financial benefits of focusing on Zohydro ER for Pernix Therapeutics?
The focus on Zohydro ER is expected to contribute to revenue growth and profitability, with anticipated annualized cost savings of $7-$8 million.
Sources
- FDA Provides Facts About Zohydro - FDA
- Pernix Announces Reorganization of Sales Force to Focus on Zohydro ER and Silenor - GlobeNewswire
- Global Opioid Induced Constipation Market Size, Forecasts to 2033 - Spherical Insights
- Zohydro ER Division Director’s Review and Summary Basis for Approval - FDA
- Pernix Provides Update On Availability Of Zohydro ER With BeadTek 20mg Strength - GlobeNewswire
Last updated: 2024-12-30
