Synjardy XR: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections
Introduction
Synjardy XR, a combination of empagliflozin and metformin hydrochloride, is a significant treatment option for adults with type 2 diabetes. Approved by the U.S. FDA in December 2016, this medication has been designed to improve glycemic control when used along with diet and exercise.
Clinical Trials and Approval
The FDA approval of Synjardy XR was based on results from multiple clinical trials that examined the co-administration of empagliflozin and metformin, either alone or in combination with other medications like sulfonylurea, in the treatment of adults with type 2 diabetes[4][5].
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Pivotal Bioequivalence Studies: The approval was supported by bioequivalence studies comparing the fixed-dose combination (FDC) of empagliflozin and metformin XR tablets to the co-administration of empagliflozin and metformin hydrochloride extended-release in healthy volunteers. Specifically, studies 1276.15 and 1276.28 demonstrated bioequivalence for the 25mg/1000mg and 10mg/1000mg tablet strengths, respectively[3].
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Clinical Efficacy: These trials showed that the combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, effectively improved blood glucose levels in adults with type 2 diabetes. Empagliflozin works by removing excess glucose through the urine, while metformin lowers glucose production by the liver and its absorption in the intestine[4].
Mechanism of Action and Indications
Mechanism of Action
- Empagliflozin: Blocks glucose re-absorption in the kidneys, leading to the removal of excess glucose through the urine.
- Metformin: Reduces glucose production by the liver and its absorption in the intestine[4].
Indications
- Synjardy XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate. It is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis[1].
Market Analysis
Market Position
- Synjardy XR is marketed by Boehringer Ingelheim and Eli Lilly and Company, making it the eighth FDA-approved treatment to emerge from their partnership. This collaboration has significantly expanded the treatment options for adults with type 2 diabetes[4].
Patent and Generic Landscape
- Synjardy XR is protected by nine patents in the U.S. and has 209 patent family members in 41 countries. The drug was eligible for patent challenges starting August 1, 2018, and there have been several patent litigation cases, indicating strong interest in generic launch[2].
Sales and Forecast
- While specific global sales figures for Synjardy XR are not publicly available in the provided sources, the drug's approval and its position as a convenient once-daily treatment option suggest a strong market presence. The combination of empagliflozin and metformin addresses a significant need for adults with type 2 diabetes who often take multiple medications daily[4].
Projections and Future Outlook
Market Growth
- Given the increasing prevalence of type 2 diabetes and the need for effective, convenient treatment options, Synjardy XR is likely to continue to be a significant player in the diabetes treatment market. The drug's once-daily dosing regimen and the complementary mechanisms of action of its components make it an attractive option for both patients and healthcare providers[4].
Generic Entry
- The potential for generic entry, with 63% of patent challenges decided in favor of generic patent challengers, could impact the market dynamics in the future. However, the complexity of developing generic versions of combination drugs like Synjardy XR may delay such entries[2].
Clinical Trials and Post-Market Studies
- While the initial clinical trials supported the FDA approval, ongoing and future post-market studies will continue to provide insights into the long-term efficacy and safety of Synjardy XR. These studies are crucial for establishing the drug's position in the treatment guidelines for type 2 diabetes[3].
Key Considerations for Healthcare Providers
Dosage and Administration
- Synjardy XR is available in several strengths (5mg/1000mg, 10mg/1000mg, 12.5mg/1000mg, and 25mg/1000mg) and should be taken once daily. Patients with renal impairment require careful assessment and monitoring of renal function before and during treatment[1].
Safety and Precautions
- Healthcare providers should be aware of potential side effects such as urosepsis, pyelonephritis, hypoglycemia, genital mycotic infections, and vitamin B12 deficiency. Monitoring and prompt treatment of these conditions are essential[1].
Key Takeaways
- Clinical Efficacy: Synjardy XR has been shown to effectively improve glycemic control in adults with type 2 diabetes through the combination of empagliflozin and metformin.
- Market Position: Marketed by Boehringer Ingelheim and Eli Lilly and Company, Synjardy XR offers a convenient once-daily treatment option.
- Patent Landscape: Protected by multiple patents, but eligible for generic challenges.
- Future Outlook: Likely to remain a significant treatment option due to its efficacy and convenience, with ongoing post-market studies providing further insights.
FAQs
What is Synjardy XR used for?
Synjardy XR is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate[1].
How does Synjardy XR work?
Synjardy XR works through the combination of empagliflozin, which blocks glucose re-absorption in the kidneys, and metformin, which reduces glucose production by the liver and its absorption in the intestine[4].
What are the potential side effects of Synjardy XR?
Potential side effects include urosepsis, pyelonephritis, hypoglycemia, genital mycotic infections, and vitamin B12 deficiency. Monitoring and prompt treatment of these conditions are essential[1].
Is Synjardy XR approved for type 1 diabetes or diabetic ketoacidosis?
No, Synjardy XR is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis[1].
What is the dosage regimen for Synjardy XR?
Synjardy XR should be taken once daily, with available strengths including 5mg/1000mg, 10mg/1000mg, 12.5mg/1000mg, and 25mg/1000mg[1].
Sources
- FDA Label: SYNJARDY XR (empagliflozin and metformin hydrochloride) extended-release tablets[1].
- Drug Patent Watch: SYNJARDY XR Drug Patent Profile[2].
- FDA Clinical Pharmacology Review: 208658Orig1s000 ClinPharmR.pdf[3].
- PR Newswire: U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride) extended-release tablets for adults with type 2 diabetes[4].
- Lilly Investor Relations: U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride) extended-release tablets for adults with type 2 diabetes[5].
