Introduction to TOPICORT LP
TOPICORT LP, containing the active ingredient desoximetasone, is a topical corticosteroid used to treat various skin conditions, including plaque psoriasis, dermatitis, and eczema. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.
Clinical Trials Overview
Trial DSXS-1303: Pediatric Safety and Efficacy
A significant clinical trial for TOPICORT LP is Trial DSXS-1303, which was conducted to evaluate the safety and efficacy of desoximetasone topical spray, 0.25%, in pediatric patients with moderate to severe plaque psoriasis. This open-label, safety, and pharmacokinetic trial enrolled 129 subjects aged 2 to less than 18 years and treated them with TOPICORT Topical Spray under maximal use conditions for 4 weeks.
- Key Findings:
- The trial revealed that 35.0% of subjects in the 12- to less-than-18-year age group, 43.3% in the 6- to less-than-12-year age group, and 20.0% in the 2- to less-than-6-year age group demonstrated hypothalamic-pituitary-adrenal (HPA) axis suppression[1].
- Adrenal suppression was reversible in 80.6% of subjects upon retesting at least 4 weeks after treatment cessation[1].
Implications for Pediatric Use
The high incidence of HPA axis suppression observed in this trial led the FDA reviewer to recommend against expanding the indication for TOPICORT LP to the pediatric population. This decision highlights the need for careful consideration of systemic toxicity risks associated with topical corticosteroids in pediatric patients[1].
Market Analysis
Global Topical Corticosteroids Market
The global topical corticosteroids market, which includes products like TOPICORT LP, is experiencing significant growth.
- Market Size and Growth:
- The market was valued at USD 4.85 billion in 2021 and is projected to reach USD 8.19 billion by 2030, growing at a CAGR of 6% during the forecast period[2].
- Regional Dominance:
- North America emerged as the largest market in 2021, with a market share of around 38% and revenue of USD 1.84 billion. The Asia Pacific region is expected to grow at the fastest CAGR during the forecast period[2].
Segment Analysis
- Medication Types:
- The market is segmented by medication types such as ointments, creams, liquids, lotions, gels, oils, pastes, sprays, and others. In 2021, the creams segment dominated the market with a 20% market share and revenue of USD 0.97 billion[2].
- Application:
- Topical corticosteroids, including TOPICORT LP, are widely used to treat skin conditions such as rash, dermatitis, itching, eczema, and psoriasis. The continuous growth of the geriatric population and the increasing prevalence of skin diseases are driving the demand for these products[2].
Market Projections
Future Growth Drivers
- Increasing Awareness and Education:
- The expansion of the topical corticosteroids market is facilitated by an increased level of education regarding the advantages of artificially produced corticosteroids. This awareness is expected to continue driving market growth[2].
- Research and Development:
- The broadening body of knowledge in medical research and the increasing number of product launches or approvals by regulatory agencies are expected to propel the market forward[2].
Regional Growth
- Asia Pacific:
- The Asia Pacific region is anticipated to grow at the fastest CAGR due to increasing government initiatives, medical tourism, expanding research activities, and a large unexplored market. The presence of numerous dermatology clinics and the rising demand for high-quality healthcare in this region are also significant factors[2].
Competitive Landscape
Generic Equivalents
- Lupin’s FDA Approval:
- Lupin Limited received FDA approval for generic versions of Desoximetasone Cream USP, 0.05% and Desoximetasone Cream USP, 0.25%, which are AB-rated generic equivalents of Taro Pharmaceuticals’ Topicort® LP Emollient Cream and Topicort® Cream. This competition can impact the market share of the original product but also indicates the demand and acceptance of desoximetasone-based treatments[5].
Key Takeaways
- Clinical Trials: The pediatric trial DSXS-1303 highlighted significant HPA axis suppression in children, leading to a recommendation against pediatric use.
- Market Size and Growth: The global topical corticosteroids market is projected to grow from USD 4.85 billion in 2021 to USD 8.19 billion by 2030.
- Regional Dominance: North America is currently the largest market, but the Asia Pacific region is expected to grow the fastest.
- Segment Analysis: Creams are the dominant form of topical corticosteroids, driven by their effectiveness in treating various skin conditions.
- Future Growth Drivers: Increased awareness, research, and regulatory approvals will continue to drive market growth.
FAQs
What is the current market size of the global topical corticosteroids market?
The global topical corticosteroids market was valued at USD 4.85 billion in 2021[2].
What is the projected growth rate of the global topical corticosteroids market?
The market is growing at a CAGR of 6% from 2021 to 2030[2].
Which region dominates the global topical corticosteroids market?
North America currently dominates the market, but the Asia Pacific region is expected to grow the fastest during the forecast period[2].
What are the primary uses of TOPICORT LP?
TOPICORT LP is used to treat skin conditions such as plaque psoriasis, dermatitis, itching, eczema, and other inflammatory skin diseases[1][5].
Are there any generic versions of TOPICORT LP available?
Yes, Lupin Limited has received FDA approval for generic versions of Desoximetasone Cream USP, 0.05% and Desoximetasone Cream USP, 0.25%, which are AB-rated generic equivalents of Taro Pharmaceuticals’ Topicort® LP Emollient Cream and Topicort® Cream[5].
What were the key findings of Trial DSXS-1303 for TOPICORT LP in pediatric patients?
The trial found a significant incidence of HPA axis suppression in pediatric patients, leading to a recommendation against expanding the indication for pediatric use[1].
Sources
- FDA Clinical Review and Evaluation: TOPICORT (Desoximetasone) Topical Spray, 0.25% - FDA
- Topical Corticosteroids Market Size, Analysis, Forecasts to 2030 - Spherical Insights
- Clinical Trials Market Size, Share And Growth Report, 2031 - SkyQuest
- Confidential Protocol: Desoximetasone Topical Spray, 0.15% - ClinicalTrials.gov
- Lupin Receives FDA Approval for Generic Topicort® LP Emollient Cream and Topicort® Cream - Lupin Limited
