Introduction to Adhansia XR
Adhansia XR, developed by Adlon Therapeutics, is an extended-release central nervous system stimulant medication approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years and older. The medication contains multi-layered beads with an immediate-release layer and a controlled-release layer, providing efficacy for up to 16 hours[4].
Clinical Trials and Efficacy
FDA Approval and Clinical Studies
Adhansia XR was approved based on four clinical studies that evaluated its efficacy and safety in both adult and pediatric patients. One of the pivotal studies was a randomized, double-blind, placebo-controlled, dose-optimized phase 3 Adult Laboratory Classroom (ALC) study. This study involved 239 adults with ADHD, who were titrated to an optimal dose of Adhansia XR (25 to 100mg/day) for up to 7 weeks and then randomly assigned to either continue their optimal dose of Adhansia XR or receive a placebo for a 1-week double-blind treatment period[1].
Key Findings
The primary endpoint of the ALC study was the mean Permanent Product Measure of Performance Total (PERMP-T) scores across various timepoints. The results showed a statistically significant improvement in ADHD symptoms with Adhansia XR compared to placebo, with a least squares mean difference of 16.3 (95% CI, 7.6-24.9; P = .0003). Significant improvements were observed at multiple timepoints post-dose, from 1 to 16 hours[1].
Safety Profile
The clinical trials also assessed the safety profile of Adhansia XR. The most frequently reported treatment-related adverse events were headache (21%), decreased appetite (21%), and insomnia (16%), with most events being mild or moderate in intensity[1].
Market Analysis
Current Market Size and Growth
The global ADHD therapeutics market, which includes medications like Adhansia XR, was valued at $20.34 million in 2022 and is projected to reach $31.13 million by 2029, growing at a CAGR of 6.27%[2].
Regional Dominance
The North American market is expected to dominate the ADHD therapeutics market, driven by growing mergers and acquisitions among in-vitro diagnostic and life sciences companies. This regional growth is anticipated to be propelled by key market players expanding their product portfolios into various medical specialty domains[2].
Market Projections and Trends
Future Outlook
Despite the discontinuation of Adhansia XR sales by Adlon Therapeutics effective July 20, 2022, the overall ADHD therapeutics market is expected to continue growing. The demand for innovative and effective treatments for ADHD remains high, and new approvals and clinical trials are likely to drive market expansion[4].
Competitive Landscape
The ADHD market is highly competitive, with several key players investing in research and development to enhance their product offerings. The approval of Adhansia XR and other similar medications highlights the industry's focus on providing longer-duration treatments that can better manage ADHD symptoms throughout the day[4].
Impact of Clinical Trials on Market Dynamics
Role of Clinical Trials
Clinical trials play a crucial role in shaping the market for ADHD medications. The rigorous regulatory environment, overseen by the FDA, ensures that new treatments meet stringent safety and efficacy standards. Successful clinical trials, like those conducted for Adhansia XR, can significantly influence market acceptance and adoption of new medications[3].
Example of Adhansia XR's Clinical Impact
The supplemental New Drug Application (sNDA) approval for Adhansia XR, which included additional clinical data in adult patients, demonstrates how ongoing research can enhance the market position of a medication. This approval highlighted the drug's efficacy and safety profile, potentially increasing its appeal to healthcare providers and patients[1].
Discontinuation and Market Implications
Discontinuation of Adhansia XR Sales
Effective July 20, 2022, Adlon Therapeutics discontinued the sale of Adhansia XR. This decision may have been influenced by various factors, including market competition, regulatory considerations, or strategic business decisions. The discontinuation could impact the availability of this specific treatment option for patients but is unlikely to significantly alter the overall growth trajectory of the ADHD therapeutics market[4].
Expert Insights and Patient Impact
Clinical Perspective
According to Andrew J. Cutler, MD, the chief medical officer of Meridian Research and an investigator on Adhansia XR clinical studies, "Adhansia XR offers a methylphenidate treatment option with a longer duration of efficacy, which may be appropriate for these patients." This perspective underscores the clinical value of extended-release formulations in managing ADHD symptoms effectively throughout the day[4].
Patient Benefits
For patients, medications like Adhansia XR provide a convenient and effective treatment option. The extended-release formulation ensures that the medication's effects last up to 16 hours, which can improve adherence and reduce the need for multiple daily doses. This can significantly enhance the quality of life for individuals with ADHD[5].
Key Takeaways
- Clinical Efficacy: Adhansia XR demonstrated statistically significant improvements in ADHD symptoms in clinical trials, with efficacy lasting up to 16 hours.
- Market Growth: The global ADHD therapeutics market is projected to grow at a CAGR of 6.27% from 2022 to 2029.
- Regional Dominance: North America is expected to dominate the market due to increased mergers and acquisitions and product portfolio expansion.
- Discontinuation: Despite the discontinuation of Adhansia XR sales, the overall market for ADHD treatments is expected to continue growing.
- Clinical Impact: Successful clinical trials are crucial for the market acceptance and adoption of new ADHD medications.
FAQs
What is Adhansia XR used for?
Adhansia XR is an extended-release central nervous system stimulant medication approved for the treatment of attention deficit hyperactivity disorder (ADHD) in patients six years and older[4].
What are the key findings from the clinical trials of Adhansia XR?
Clinical trials showed that Adhansia XR significantly improved ADHD symptoms compared to placebo, with efficacy lasting up to 16 hours post-dose[1].
Why was the sale of Adhansia XR discontinued?
The sale of Adhansia XR was discontinued by Adlon Therapeutics effective July 20, 2022, though the exact reasons are not specified in available sources[4].
How does Adhansia XR compare to other ADHD medications?
Adhansia XR offers a longer duration of efficacy compared to some other methylphenidate formulations, making it a convenient option for managing ADHD symptoms throughout the day[5].
What is the expected growth of the ADHD therapeutics market?
The global ADHD therapeutics market is expected to grow from $20.34 million in 2022 to $31.13 million by 2029, at a CAGR of 6.27%[2].
Sources
- Adhansia XR Labeling Updated With Additional Clinical Data - MPR
- ADHD Therapeutics Market- Global Industry Analysis And Forecast - Maximise Market Research
- U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace
- Stimulant ADHD Medication Adhansia XR Approved By FDA - Additude Magazine
- Extended-release Adhansia XR has a clinical effect up to 16 hours - Drug Discovery Trends
