Introduction
TIVORBEX, a low-dose oral formulation of indomethacin, is a non-steroidal anti-inflammatory drug (NSAID) approved by the FDA for the treatment of mild to moderate acute pain. Here, we delve into the market dynamics and financial trajectory of TIVORBEX, examining its position within the pharmaceutical industry, key market factors, and financial performance.
Market Context
TIVORBEX is part of a broader market for NSAIDs, which are widely used for pain management. The approval of TIVORBEX was driven by the need for alternative pain management options, particularly in the context of the opioid crisis in the USA[5].
Approval and Launch
TIVORBEX was approved by the FDA and marketed by Iroko Pharmaceuticals, Inc. The drug is formulated as submicron particles, which increase the surface area, leading to faster dissolution and absorption compared to conventional immediate-release indomethacin capsules[4].
Market Segmentation
The market for TIVORBEX can be segmented based on several factors, including the type of pain being treated, patient demographics, and geographical regions.
Type of Pain
TIVORBEX is specifically approved for mild to moderate acute pain. This segmentation is crucial as it targets a specific need in the pain management market, differentiating it from other NSAIDs and opioids.
Patient Demographics
The target patient population includes individuals suffering from acute pain conditions who are seeking effective and safer alternatives to opioids. This demographic is significant given the ongoing opioid crisis and the increasing awareness of the risks associated with opioid use[5].
Geographical Regions
The market for TIVORBEX is primarily in the United States, where Iroko Pharmaceuticals, Inc. has a strong presence. However, the drug's potential extends to other regions where NSAIDs are commonly used for pain management.
Competitive Landscape
The NSAID market is highly competitive, with several established brands and generic options available. TIVORBEX competes with other low-dose NSAIDs such as ZORVOLEX (diclofenac), also marketed by Iroko Pharmaceuticals, Inc.[4].
Key Competitors
- ZORVOLEX (diclofenac): Another low-dose NSAID from the same manufacturer, targeting similar pain management needs.
- Conventional NSAIDs: Standard doses of indomethacin and other NSAIDs, which, although more potent, come with higher risks of gastrointestinal and cardiovascular side effects.
Financial Performance
The financial performance of TIVORBEX is closely tied to the overall strategy and financial health of its parent company, Iroko Pharmaceuticals, Inc., and later Zyla Life Sciences after the acquisition.
Revenue Contribution
In the first quarter of 2019, following the acquisition of five new products including TIVORBEX by Egalet (later renamed Zyla Life Sciences), the company reported $17.6 million in net product sales. This figure reflects the expanded product portfolio, including TIVORBEX, for two of the three months in the quarter[3].
Cost Structure
The financial reports of Zyla Life Sciences indicate a reduction in sales and marketing expenses, research and development expenses, and interest expenses. These reductions were partly due to the discontinuation of non-essential marketing and R&D activities, which helped in optimizing the financial performance of the company[3].
Future Projections
Zyla Life Sciences projected revenue between $80 and $90 million for 2019, indicating a positive trajectory for the company's product portfolio, which includes TIVORBEX. The company's ability to manage costs and expand its sales force contributed to this optimistic outlook[3].
Strategic Moves
Several strategic moves have been crucial for the market positioning and financial performance of TIVORBEX:
Acquisition and Integration
The acquisition of TIVORBEX by Egalet (Zyla Life Sciences) was part of a broader strategy to expand the company's product portfolio. This move allowed for the integration of new products into the existing sales and marketing infrastructure, enhancing revenue potential[3].
Sales Force Expansion
The expansion of the sales force to 87 representatives and the initiation of promotional activities for the acquired products, including TIVORBEX, were key steps in increasing market penetration and sales[3].
Financial Management
The establishment of a $20 million revolving line of credit and the reduction of various expenses helped in stabilizing the financial health of the company, ensuring a solid foundation for the growth of TIVORBEX and other products[3].
Challenges and Opportunities
Challenges
- Efficacy and Safety Concerns: There are no studies comparing the efficacy of TIVORBEX to standard doses of indomethacin or other NSAIDs, which can affect its adoption rate. Additionally, indomethacin is known for its potential gastrointestinal and cardiovascular risks[4].
- Market Competition: The NSAID market is highly competitive, with many established brands and generic options available.
Opportunities
- Opioid Crisis: The ongoing opioid crisis presents an opportunity for TIVORBEX as healthcare providers and patients seek safer alternatives for pain management[5].
- Innovative Formulation: The submicron particle formulation of TIVORBEX offers faster dissolution and absorption, which can be a selling point in a market looking for more efficient pain relief options[4].
Key Takeaways
- Market Position: TIVORBEX is positioned as a safer alternative in the NSAID market, targeting mild to moderate acute pain.
- Financial Performance: The drug contributes to the revenue growth of Zyla Life Sciences, with positive financial projections driven by cost management and sales force expansion.
- Strategic Moves: Acquisitions, sales force expansion, and financial management have been crucial for the drug's market dynamics.
- Challenges and Opportunities: Efficacy and safety concerns, market competition, and the opioid crisis are key factors influencing the drug's trajectory.
FAQs
What is TIVORBEX used for?
TIVORBEX is used for the treatment of mild to moderate acute pain.
Who manufactures TIVORBEX?
TIVORBEX is manufactured by Iroko Pharmaceuticals, Inc., and later managed by Zyla Life Sciences after the acquisition.
How does TIVORBEX differ from conventional indomethacin?
TIVORBEX is formulated as submicron particles, which increase the surface area, leading to faster dissolution and absorption compared to conventional immediate-release indomethacin capsules.
What are the potential risks associated with TIVORBEX?
TIVORBEX, like other indomethacin formulations, is associated with risks such as gastrointestinal bleeding, increased cardiovascular risk, and kidney damage.
How has the opioid crisis impacted the market for TIVORBEX?
The opioid crisis has created an increased demand for safer pain management alternatives, presenting an opportunity for TIVORBEX to gain market share.
Sources
- The Brainy Insights - Ankylosing Spondylitis Drugs Market Size Report 2028
- 2017 Annual Report - Horizon Pharma
- Biospace - Egalet Reports First Quarter 2019 Financial Results and Plan to Change Company Name to Zyla Life Sciences
- The Medical Letter - In Brief: Low-Dose Indomethacin (Tivorbex) for Pain
- ResearchGate - Effect of non-steroidal anti-inflammatory drugs on post-surgical complications against the backdrop of the opioid crisis
