DYANAVEL XR: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections
Introduction to DYANAVEL XR
DYANAVEL XR, developed by Tris Pharma, is an amphetamine extended-release tablet designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. This medication employs Tris’s unique LiquiXR® platform technology, allowing for both immediate-release and extended-release characteristics, facilitating once-daily dosing.
Clinical Trials and Efficacy
Phase 3 Clinical Trials in Adults
A significant Phase 3 clinical trial published in the Journal of Clinical Psychiatry demonstrated the efficacy and safety of DYANAVEL XR tablets in adult patients with ADHD. This randomized, double-blind, placebo-controlled, fixed-dose study assessed the efficacy and safety through the administration of serial Permanent Product Measure of Performance (PERMP) tests at various time points post-dose. The results showed statistically significant improvements in PERMP Total (PERMP-T) scores in the DYANAVEL XR group compared to the placebo group, indicating efficacy as early as 0.5 hours and lasting up to 13 hours post-dose[1].
Clinical Trials in Pediatric Patients
The efficacy of DYANAVEL XR in pediatric patients was established through previous clinical results, particularly with the DYANAVEL XR oral suspension. The FDA review process for the extended-release tablets relied on the established efficacy of the oral suspension, with a single-dose bioequivalence study bridging the two formulations. Additional post-marketing studies are required for pediatric patients aged 4-5 years to further assess safety and efficacy[4].
Safety Profile
The clinical trials revealed a safety profile consistent with other central nervous system stimulants. Common adverse events included headache, decreased appetite, irritability, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea. Most of these adverse events were mild to moderate in severity, with no serious adverse events reported during the study[1].
Market Analysis
Promotional Activities and Physician Engagement
Tris Pharma has been actively promoting DYANAVEL XR through various channels, including sales rep detailing, physician education, and paid speaking engagements. Reports from 2019 and 2020 indicate that DYANAVEL XR reached a significant number of physicians, with a notable depth of coverage in key specialties such as Pediatric Medicine, Psychiatry, and Family Medicine. The promotional mix included a variety of activities, with a median spend on each type of activity, and frequent paid meals and speaking engagements for physicians[5][2].
Market Positioning
DYANAVEL XR is well-positioned in the growing ADHD market, particularly with its approval for both children and adults. The drug's unique LiquiXR® technology and once-daily dosing regimen make it an attractive option for patients and healthcare providers. The market analysis suggests that DYANAVEL XR competes effectively with other ADHD medications such as Adhansia XR, Adzenys XR, and Vyvanse, among others[3][5].
Market Projections
Generic Entry and Patent Protection
DYANAVEL XR is protected by four US patents, with the earliest estimated generic entry date based on the last compound-claiming patent. However, various factors such as new patent filings, patent extensions, or early generic licensing could influence the actual generic entry date. This protection is crucial for maintaining market exclusivity and preventing early generic competition[3].
Growth Potential
Given the increasing prevalence of ADHD and the growing demand for effective treatments, DYANAVEL XR is poised for significant market growth. The drug's efficacy, safety profile, and convenient once-daily dosing regimen are key factors that will drive its adoption. Additionally, the ongoing promotional activities and strong physician engagement are expected to further boost its market presence[2][5].
Key Takeaways
- Efficacy and Safety: DYANAVEL XR has demonstrated efficacy and safety in both adult and pediatric patients with ADHD, with significant improvements in PERMP scores.
- Market Positioning: The drug is well-positioned in the ADHD market due to its unique technology and once-daily dosing.
- Promotional Activities: Tris Pharma has been actively engaging physicians through various promotional activities.
- Generic Protection: DYANAVEL XR is protected by four US patents, with an estimated generic entry date based on the last compound-claiming patent.
- Growth Potential: The drug has significant growth potential due to its efficacy, safety, and market demand.
FAQs
What is DYANAVEL XR used for?
DYANAVEL XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
How does DYANAVEL XR work?
DYANAVEL XR employs Tris’s unique LiquiXR® platform technology, allowing for both immediate-release and extended-release characteristics, facilitating once-daily dosing.
What are the common adverse events associated with DYANAVEL XR?
Common adverse events include headache, decreased appetite, irritability, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea.
When is the estimated generic entry date for DYANAVEL XR?
The estimated generic entry date is based on the last compound-claiming patent, but actual entry could be influenced by various factors such as new patent filings or early generic licensing.
How is DYANAVEL XR promoted in the market?
DYANAVEL XR is promoted through sales rep detailing, physician education, paid speaking engagements, and frequent paid meals for physicians.
Sources
- Tris Pharma Announces Publication of Study Results Highlighting the Efficacy and Safety of DYANAVEL® XR (amphetamine) Tablets for the Treatment of the Symptoms of ADHD in Adults. Tris Pharma.
- Dyanavel XR 2020 report. MDDetails.
- DYANAVEL XR 10 Drug Patent Profile. DrugPatentWatch.
- NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets). FDA.
- Dyanavel XR 2019 report. MDDetails.
