Introduction
DYANAVEL XR, an amphetamine extended-release formulation, is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.
Clinical Trials Update
Ongoing Trials
One of the notable ongoing clinical trials for DYANAVEL XR is focused on treating co-occurring fatigue symptoms in adults with ADHD. This Phase 4 trial, conducted by Tris Pharma Inc., is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of DYANAVEL XR in reducing fatigue symptoms.
- Study Design: The trial involves an 8-week single-center study where subjects are randomly assigned to either the DYANAVEL XR group or the placebo group. The study aims to enroll 50 subjects, with a minimum of 44 subjects expected to complete the trial[1].
- Primary Objective: The primary goal is to determine whether DYANAVEL XR leads to a statistically significant reduction in fatigue symptoms compared to placebo, as measured by the Fatigue Symptom Inventory.
Previous Trials
Previous clinical trials have established the efficacy and safety of DYANAVEL XR in treating ADHD. For instance, a laboratory classroom study in children aged 6 to 12 years showed that DYANAVEL XR significantly improved attention and behavior and reduced impulsivity and hyperactivity compared to placebo. This study demonstrated a statistically significant difference versus placebo starting at one hour and lasting up to 13 hours after dosing[5].
Market Analysis
Current Market Position
DYANAVEL XR is part of the amphetamine extended-release market, which is competitive due to the presence of other ADHD medications. However, its unique formulation and dosing flexibility (available as both oral suspension and chewable tablets) provide it with a distinct market position.
- Dosage Forms: DYANAVEL XR is available in multiple dosage forms, including oral suspension and chewable tablets, which can be swallowed whole or chewed. This versatility can appeal to a broader range of patients[4].
- Side Effects: The side effect profile of DYANAVEL XR is similar to other once-daily ADHD medications with the same active ingredient. Common side effects include epistaxis, allergic rhinitis, and upper abdominal pain[5].
Patent and Exclusivity
DYANAVEL XR is protected by multiple patents, with ten patents currently in effect. The estimated loss of exclusivity (LOE) date is crucial for understanding when generic versions might enter the market.
- Patent Protection: The drug has 21 international patents and 7 U.S. patents, with the generic entry opportunity date estimated based on the last compound-claiming patent and regulatory exclusivity protection[2].
Market Projections
Sales and Revenue
While specific sales figures for DYANAVEL XR are not publicly available without a subscription, the drug's market performance can be inferred from its approval and ongoing clinical trials.
- Market Growth: The ADHD medication market is expected to grow due to increasing diagnoses and the need for effective treatments. DYANAVEL XR, with its proven efficacy and flexible dosing options, is well-positioned to capture a significant share of this growing market.
- Generic Entry: The potential for generic entry will impact future sales. However, the complex formulation of DYANAVEL XR and its patent protection are likely to delay generic competition, allowing the brand to maintain market share for several years[2].
Future Developments
Future developments, including additional clinical trials and potential new indications, could further enhance the market position of DYANAVEL XR.
- Pediatric Studies: There is a requirement for post-marketing studies in pediatric patients aged 4-5 years, which could expand the drug's use in younger populations and increase its market reach[4].
- New Indications: The ongoing trial focusing on fatigue symptoms in adults with ADHD could lead to new indications and broader use of the drug, potentially increasing its market share.
Key Takeaways
- Clinical Trials: DYANAVEL XR is currently being evaluated in a Phase 4 trial for treating co-occurring fatigue symptoms in adults with ADHD.
- Market Position: The drug has a strong market position due to its unique formulation and dosing flexibility.
- Patent Protection: DYANAVEL XR is protected by multiple patents, delaying potential generic competition.
- Future Developments: Ongoing and future clinical trials, including those in pediatric populations, could expand the drug's use and market share.
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.
What are the common side effects of DYANAVEL XR?
Common side effects include epistaxis (nosebleed), allergic rhinitis, and upper abdominal pain.
Is DYANAVEL XR available in different dosage forms?
Yes, DYANAVEL XR is available as both oral suspension and chewable tablets, which can be swallowed whole or chewed.
What is the current status of generic entry for DYANAVEL XR?
The generic entry opportunity date is estimated based on the last compound-claiming patent and regulatory exclusivity protection, but specific dates are not publicly available without subscription.
Are there any ongoing clinical trials for DYANAVEL XR?
Yes, there is an ongoing Phase 4 trial evaluating the efficacy of DYANAVEL XR in treating co-occurring fatigue symptoms in adults with ADHD.
Sources
- ClinicalTrials.gov - A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
- DrugPatentWatch - DYANAVEL XR Drug Patent Profile.
- Taylor & Francis Online - A review of amphetamine extended release once-daily options for the treatment of ADHD.
- FDA - NDA 210526 Dyanavel XR (Amphetamine Extended-Release Tablets).
- Tris Pharma - Tris Pharma Announces the Launch of DYANAVEL™ XR Amphetamine Extended-Release Oral Suspension CII for the Treatment of Children with ADHD.
