Introduction to Elyxyb
Elyxyb, a celecoxib oral solution, is a groundbreaking medication in the pain management sector, particularly for the acute treatment of migraine with or without aura in adults. It is the only FDA-approved, ready-to-use oral solution in its class, making it a significant player in the non-opioid pain management market[1][3][4].
Market Size and Growth Prospects
The market for acute migraine treatments is substantial and growing. The U.S. oral migraine drug market size was estimated to be $1.8 billion in 2022 and is projected to reach $2.3 billion by 2025[3][4].
On a broader scale, the pain management therapeutics market is expected to reach $101.27 billion by 2029, growing at a CAGR of 4.3% from 2022 to 2030. This growth indicates a robust demand for effective pain management solutions, particularly non-opioid alternatives[1].
Competitive Advantage of Elyxyb
Elyxyb stands out due to its unique formulation and benefits. As a member of the cox-2 inhibitors drug class, celecoxib is known for its fast-acting properties and lower gastrointestinal (GI) side effects compared to other NSAIDs. This makes Elyxyb an attractive option for patients and physicians seeking to avoid opioid-based treatments[1][3].
Commercialization and Distribution
Scilex Holding Company, the majority-owned subsidiary of Sorrento Therapeutics, has a well-established commercial and managed care team. This team has successfully launched and grown market access for other products like ZTlido (lidocaine topical system), covering over 200 million lives in the U.S. The same team is now focused on the commercial launch of Elyxyb, which began in April 2023[2][3].
Scilex is also negotiating a distribution agreement with a major third-party logistics provider to ensure efficient warehousing and distribution of Elyxyb. This strategic approach positions Scilex to effectively market and distribute Elyxyb, leveraging its existing commercial infrastructure[3].
Pricing Strategy
The cost for Elyxyb (25 mg/mL) oral solution is around $931 for a supply of 28.8 milliliters, which translates to approximately $32.31 per unit. This pricing is for cash-paying customers and does not reflect potential discounts or insurance coverage[5].
Given the unique positioning of Elyxyb as a first-line treatment for migraines and its lack of generic alternatives, the pricing strategy appears to balance the need for revenue generation with patient accessibility. However, the high cost may pose a barrier for some patients, highlighting the importance of discount programs and insurance coverage.
Patient Assistance and Discount Programs
To mitigate the high cost, Scilex and other providers offer discount cards and patient assistance programs. For example, the Drugs.com Discount Card can save patients up to 80% off the cost of Elyxyb, making it more affordable for those without comprehensive insurance coverage[5].
Patent Protection and Market Exclusivity
Elyxyb is protected by six Orange Book-listed method-of-use patents that expire in 2036. This patent protection ensures that Scilex will maintain market exclusivity for Elyxyb for several years, allowing the company to maximize its revenue potential without immediate generic competition[1].
Market Projections and Future Outlook
Given the strong market demand for non-opioid pain management solutions and the unique benefits of Elyxyb, the product is expected to contribute significantly to Scilex’s revenue growth. The company anticipates that Elyxyb will diversify its revenue stream, enhance its topline, and drive substantial near- and long-term accretion to its cash flows and earnings[3].
The Canadian market also presents a significant opportunity, with the migraine therapeutics market estimated to reach approximately $400 million by 2025. Scilex has filed a New Drug Submission (NDS) to Health Canada for the approval of Elyxyb in Canada, further expanding its market reach[4].
Key Takeaways
- Market Size: The U.S. oral migraine drug market is projected to reach $2.3 billion by 2025.
- Growth Prospects: The broader pain management therapeutics market is expected to reach $101.27 billion by 2029.
- Competitive Advantage: Elyxyb is the only FDA-approved, ready-to-use oral solution for acute migraine treatment with lower GI side effects.
- Pricing Strategy: Around $931 for a 28.8 milliliter supply, with potential discounts through patient assistance programs.
- Patent Protection: Protected by six Orange Book-listed method-of-use patents until 2036.
- Future Outlook: Expected to significantly contribute to Scilex’s revenue growth and expand into the Canadian market.
FAQs
What is Elyxyb used for?
Elyxyb is used for the acute treatment of migraine with or without aura in adults. It is the only FDA-approved, ready-to-use oral solution in its class.
How much does Elyxyb cost?
The cost for Elyxyb (25 mg/mL) oral solution is around $931 for a supply of 28.8 milliliters, which translates to approximately $32.31 per unit.
Is Elyxyb covered by insurance?
While specific insurance coverage varies, Elyxyb is part of Scilex’s commercial offerings, which include managed care arrangements covering over 200 million lives in the U.S.
What are the benefits of Elyxyb over other NSAIDs?
Elyxyb has the potential to have the lowest GI side effects of all NSAIDs and is fast-acting, making it a preferred option for many patients.
How long is Elyxyb protected by patents?
Elyxyb is protected by six Orange Book-listed method-of-use patents that expire in 2036.
Is Elyxyb available in Canada?
Scilex has filed a New Drug Submission (NDS) to Health Canada for the approval of Elyxyb in Canada, but it is not yet approved for use there.
Sources
- Biospace: Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., acquires rights to FDA-approved Elyxyb in the U.S. and Canada for the acute treatment of migraine.
- GlobeNewswire: Scilex Holding Company Sets Launch Price of $595 per 150ml bottle of Gloperba.
- Biospace: Scilex Holding Company announces the commercial launch of Elyxyb (celecoxib oral solution) in the U.S.
- Scilex Holding Company: Scilex Holding Company Announces Filing of a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate.
- Drugs.com: Elyxyb Prices, Coupons, Copay Cards & Patient Assistance.
