Introduction
SMOFLIPID 20% is a lipid injectable emulsion developed by Fresenius Kabi, approved by the FDA on July 13, 2016, for use in adults as a source of calories and essential fatty acids for parenteral nutrition. This article provides an update on the clinical trials, market analysis, and projections for SMOFLIPID 20%.
Clinical Trials Update
Adult Clinical Trials
The initial approval of SMOFLIPID 20% was based on several clinical trials that evaluated its safety and efficacy in adult patients. Studies such as FE-SM-04-CH and 05-SMOF-006 compared SMOFLIPID 20% with other standard-of-care lipid emulsions like Lipovenös 20% and Intralipid 20%. These trials showed similar increases in mean triglyceride levels and no significant differences in safety and tolerance between the treatment groups[1][4].
Pediatric Clinical Trials
Following the initial approval, the FDA required additional clinical trials to assess the safety and efficacy of SMOFLIPID 20% in pediatric patients under the Pediatric Research Equity Act (PREA). Studies like 00-SMOF-002 and 00-SMOF-004 were conducted to evaluate the safety and tolerance in pediatric patients, including neonates. These trials found that the adverse events were generally mild to moderate, with no serious adverse events leading to death directly attributed to the study medication. However, there were some deaths in both treatment groups, which were considered related to prematurity rather than the study drug[1][4].
Post-Marketing Requirements (PMRs)
The FDA mandated several post-marketing requirements to further assess the safety of SMOFLIPID 20%, particularly focusing on the effects of phytosterols and the risk of parenteral nutrition-associated liver disease (PNALD) and intestinal failure-associated liver disease (IFALD). These include randomized clinical trials in hospitalized adult patients and pediatric patients to evaluate clinical safety outcomes such as sepsis, mortality, and liver injury[1][4].
Market Analysis
Market Position
SMOFLIPID 20% is currently marketed by Fresenius Kabi USA and is protected by one FDA Regulatory Exclusivity but has no US patents. This exclusivity affects the timing of potential generic entries, which are estimated to be possible after the regulatory exclusivity period ends[2].
Competitive Landscape
The market for intravenous lipid emulsions is competitive, with other products like Intralipid 20% and Omegaven. SMOFLIPID 20% differentiates itself with a unique blend of soybean oil, medium-chain triglycerides (MCT), olive oil, and fish oil, providing a balanced mix of essential fatty acids and omega-3 fatty acids[4][5].
Sales and Revenue
While specific global sales figures for SMOFLIPID 20% are not publicly disclosed, the product's unique formulation and the growing demand for parenteral nutrition solutions contribute to its market presence. The lack of direct competitors with the same multi-component lipid blend positions SMOFLIPID 20% favorably in the market.
Projections
Market Growth
The demand for parenteral nutrition solutions is expected to grow due to increasing cases of malnutrition, particularly in hospitalized patients. SMOFLIPID 20%, with its balanced fatty acid profile and lack of significant safety concerns, is well-positioned to capture a significant share of this growing market.
Generic Entry
The earliest date for a generic version of SMOFLIPID 20% is dependent on the expiration of the FDA Regulatory Exclusivity. However, factors such as new patent filings, patent extensions, or early generic licensing could influence the actual generic entry date. This uncertainty makes it challenging to predict exactly when generics will enter the market, but it is likely to be after the current exclusivity period[2].
Clinical Trial Outcomes
The ongoing and required clinical trials will provide further insights into the safety and efficacy of SMOFLIPID 20%, particularly in pediatric populations. Positive outcomes from these trials could strengthen the product's market position and expand its indications, while any adverse findings could impact its market share.
Pharmacodynamic and Pharmacokinetic Profile
Components and Effects
SMOFLIPID 20% is a mixture of soybean oil, MCT, olive oil, and fish oil, providing a balanced source of energy, essential fatty acids, and omega-3 fatty acids. The pharmacodynamic effects include the provision of energy, the synthesis of eicosanoids, and the structural support of cell membranes. The inclusion of MCT reduces the risk of lipid peroxidation and hepatic dysfunction, while fish oil contributes to anti-inflammatory effects[5].
Metabolism
Intravenous lipid emulsions like SMOFLIPID 20% are metabolized similarly to naturally occurring chylomicrons, leading to an increase in plasma triglyceride levels. These triglycerides are then hydrolyzed by lipoprotein lipase to release free fatty acids, which serve as a substrate for energy production through beta oxidation[4].
Key Takeaways
- Clinical Trials: Ongoing and required trials focus on pediatric safety and the effects of phytosterols, with positive outcomes expected to strengthen the product's market position.
- Market Analysis: SMOFLIPID 20% holds a unique position in the market due to its multi-component lipid blend and regulatory exclusivity.
- Projections: The product is expected to grow in market share due to increasing demand for parenteral nutrition solutions, though generic entry dates are uncertain.
- Pharmacodynamic Profile: The balanced fatty acid composition provides a favorable pharmacodynamic effect, including energy provision and anti-inflammatory properties.
FAQs
What is SMOFLIPID 20% used for?
SMOFLIPID 20% is used as a source of calories and essential fatty acids for parenteral nutrition in patients where oral or enteral nutrition is not possible, insufficient, or contraindicated.
What are the components of SMOFLIPID 20%?
SMOFLIPID 20% is a mixture of soybean oil, medium-chain triglycerides (MCT), olive oil, and fish oil.
What are the post-marketing requirements for SMOFLIPID 20%?
The FDA has mandated several post-marketing requirements, including randomized clinical trials to evaluate the safety outcomes of sepsis, mortality, and liver injury in both adult and pediatric patients.
When can generic versions of SMOFLIPID 20% enter the market?
Generic versions can enter the market after the expiration of the FDA Regulatory Exclusivity, although the exact date may be influenced by various factors such as new patent filings or early generic licensing.
What are the pharmacodynamic effects of SMOFLIPID 20%?
The pharmacodynamic effects include the provision of energy, the synthesis of eicosanoids, and the structural support of cell membranes, with a balanced omega-6 to omega-3 fatty acid ratio.
Sources
- FDA: 207648Orig1s000 SumR - accessdata.fda.gov
- DrugPatentWatch: SMOFLIPID 20% Drug Patent Profile
- Wiley Online Library: Material Trends and Clinical Costings in Systematically Identified ...
- FDA: Office of Clinical Pharmacology Review - FDA
- Fresenius Kabi: PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION - SMOFLIPID 20%
