Introduction to RIOMET ER
RIOMET ER is a metformin hydrochloride extended-release oral suspension, approved by the U.S. FDA for the treatment of type 2 diabetes mellitus (T2DM) in adults and pediatric patients 10 years of age and older. This formulation is particularly beneficial for patients with potential swallowability issues[1][4].
Clinical Trials and Approval Process
The approval of RIOMET ER was based on a bioequivalence (BE) study that bridged it to Glucophage XR, an existing extended-release metformin product. Since Glucophage XR is indicated for adults only, a further bridge to Glucophage IR (an immediate-release metformin formulation approved for both adults and pediatric patients) was necessary to support the pediatric indication for RIOMET ER. This three-way bridge ensured that the safety and efficacy of metformin extended release could be inferred for both adult and pediatric patients[1].
Pediatric Indication
The FDA required an initial pediatric study plan (iPSP) and a pharmacokinetic (PK) study in pediatric patients with T2DM to support the use of RIOMET ER in this age group. The studies demonstrated that the glycemic control and adverse profile of metformin IR were similar in adults and pediatric patients aged 10-16 years, supporting the extension of RIOMET ER's indication to pediatric patients[1].
Market Analysis
Current Market Size and Forecast
The global metformin hydrochloride market, which includes products like RIOMET ER, was valued at approximately USD 268.95 million in 2022. It is projected to grow to around USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of 4.7%[2].
Regional Market Dynamics
The Asia-Pacific region is expected to emerge as the leading market during the forecast period, driven by increasing prevalence of diabetes and growing healthcare infrastructure in countries like China and India[2].
Key Players
Several pharmaceutical companies are key players in the metformin hydrochloride market, including Shouguang Fukang Pharmaceutical, CR Double-Crane, Wanbury, Keyuan Pharmaceutical, and Sun Pharma, which launched RIOMET ER in the U.S. in 2020[2][5].
Market Projections and Trends
Growing Demand for Diabetes Management
The increasing global prevalence of type 2 diabetes mellitus is a significant driver for the metformin hydrochloride market. As the demand for effective and convenient diabetes management solutions rises, products like RIOMET ER, which offer extended-release formulations and ease of administration, are likely to see increased adoption[2].
Innovations in Diabetes Treatment
Recent years have seen the launch of various new formulations and combinations, such as Glenmark Pharmaceuticals' metformin hydrochloride extended-release tablets and AstraZeneca's Xigduo XR tablets containing metformin HCL and dapagliflozin. These innovations indicate a dynamic market with continuous improvements in treatment options[5].
Clinical Trials Landscape
While RIOMET ER itself was approved through bioequivalence studies rather than large-scale clinical trials, the broader landscape of clinical trials in diabetes treatment is robust. Clinical trials play a critical role in shaping healthcare practices, and the U.S. clinical trials market, which includes trials for new diabetes treatments, is expected to grow significantly from USD 27.07 billion in 2024 to USD 41.57 billion by 2033[3].
Safety and Efficacy Considerations
Renal Function Monitoring
RIOMET ER is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m². Patients with an eGFR between 30 to 45 mL/minute/1.73 m² should be carefully monitored, and the drug should be discontinued if the eGFR falls below 30 mL/minute/1.73 m². Regular assessment of renal function is crucial to avoid complications such as lactic acidosis[4].
Other Precautions
Patients undergoing radiologic studies with contrast agents or surgery should have their RIOMET ER therapy temporarily discontinued to avoid risks associated with volume depletion and renal impairment[4].
Key Takeaways
- Approval and Indication: RIOMET ER is approved for type 2 diabetes management in adults and pediatric patients 10 years and older, based on bioequivalence studies with Glucophage XR and Glucophage IR.
- Market Growth: The global metformin hydrochloride market is projected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030.
- Regional Dynamics: The Asia-Pacific region is expected to lead the market growth.
- Safety and Efficacy: Regular monitoring of renal function is essential to ensure safe use of RIOMET ER.
- Clinical Trials Landscape: The broader clinical trials market for diabetes treatments is expanding, driven by the need for innovative healthcare solutions.
FAQs
What is RIOMET ER used for?
RIOMET ER is used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus[1][4].
How was RIOMET ER approved?
RIOMET ER was approved through a bioequivalence study that bridged it to Glucophage XR and further to Glucophage IR to support its indication in both adults and pediatric patients[1].
What are the key precautions for using RIOMET ER?
Key precautions include monitoring renal function, avoiding use in patients with an eGFR below 30 mL/minute/1.73 m², and temporarily discontinuing the drug during radiologic studies with contrast agents or surgery[4].
What is the projected market growth for metformin hydrochloride?
The global metformin hydrochloride market is expected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030, with a CAGR of 4.7%[2].
Which region is expected to lead the market growth for metformin hydrochloride?
The Asia-Pacific region is expected to emerge as the leading market during the forecast period[2].
What are some recent innovations in diabetes treatment related to metformin?
Recent innovations include the launch of metformin hydrochloride extended-release tablets by Glenmark Pharmaceuticals and Xigduo XR tablets containing metformin HCL and dapagliflozin by AstraZeneca[5].
