Introduction to Dextroamphetamine
Dextroamphetamine, a central nervous system (CNS) stimulant, is widely used in the treatment of attention deficit hyperactivity disorder (ADHD) and other conditions such as narcolepsy. It is the active ingredient in several FDA-approved medications, including Adderall.
Recent Clinical Trials: ADAIR by Vallon Pharmaceuticals
Phase III SEAL Trial
Vallon Pharmaceuticals recently announced the results of its Phase III SEAL trial for ADAIR, an abuse-deterrent formulation of immediate-release (IR) dextroamphetamine. The trial aimed to evaluate the efficacy and safety of ADAIR in preventing abuse by recreational drug users.
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Primary Endpoint: The trial failed to meet its primary endpoint, which was Emax Drug Liking. Although ADAIR's score was consistent with earlier trials, the reference dextroamphetamine did not score as high as expected, leading to a lack of statistical significance[1].
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Secondary Endpoints: Despite the primary endpoint failure, ADAIR performed well on pharmacodynamic (PD) secondary endpoints. It showed significantly lower drug liking scores compared to reference dextroamphetamine at multiple time points. Additionally, ADAIR demonstrated higher scores on the Subject Rated Assessment of Intranasal Irritability (SRAII), indicating it was more irritating and less comfortable to snort than crushed dextroamphetamine[1].
Market Analysis of Dextroamphetamine
Current Market Landscape
The ADHD market, which is a significant segment for dextroamphetamine, is expected to decline from $11.9 billion in 2022 to $10.9 billion by 2032, primarily due to patent expiries and the launch of generic products. Vyvanse, a leading branded ADHD product, saw its US patent expire in 2023, leading to the introduction of generic lisdexamfetamine dimesylate products[3].
Key Players in the Dextroamphetamine API Market
The global dextroamphetamine sulfate API market involves several key players, including Johnson Matthey, Cambrex, Curia Global, Mallinckrodt Pharm, and others. These companies are crucial in the supply chain for manufacturing dextroamphetamine-based medications[2].
Market Drivers and Restraints
Drivers
- Increasing Awareness of Adult ADHD: The growing awareness of adult ADHD is expected to increase the number of treated cases, potentially boosting the demand for ADHD medications like dextroamphetamine[3].
- Launch of New Products: Although the new pipeline agents are not expected to show significant improvements in efficacy, they may offer differentiation in terms of duration of action and reduced side effects. Products like Cingulate’s CTx-1301 and Axsome Therapeutic’s solriamfetol hydrochloride are anticipated to launch in the US market by 2026[3].
Restraints
- Patent Expiries and Generic Launches: The expiration of patents for branded ADHD products and the subsequent launch of generics are significant barriers to market growth. Generic products are often preferred by payers, which can erode the sales of branded products[3].
- API Shortages: Shortages of active pharmaceutical ingredients (APIs) required for the manufacturing of generic ADHD products have affected the market. However, these shortages are expected to be resolved by 2027[3].
Market Projections
CNS Stimulant Drugs Market
The Central Nervous System Stimulant Drugs Market, which includes dextroamphetamine, is anticipated to grow during the forecast period despite some challenges. Strategic activities such as product launches and mergers are expected to contribute to this growth. For example, Tris Pharma Inc.'s launch of Dyanavel XR, an amphetamine extended-release tablet, is a recent development in this market[5].
Forecast and Trends
- Growth Forecast: The CNS stimulant drugs market is expected to grow, driven by the rise in CNS disorders and an increasing geriatric population. However, the growth will be hindered by the numerous side effects associated with these drugs[5].
- Regional Analysis: The market is segmented geographically, with North America being a significant region. The growth in this region will be influenced by the launch of new products and the ongoing demand for ADHD treatments[5].
Pipeline and Future Developments
Upcoming Products
Several pipeline agents are expected to launch in the US market by 2026, including Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These products will compete with existing treatments and may offer improved profiles in terms of duration of action and side effect reduction[3].
Practice-Changing Drugs in 2025
While not specifically focused on dextroamphetamine, the broader pharmaceutical landscape in 2025 is expected to see significant advancements. New therapies and drug classes will be introduced, including some that may indirectly impact the ADHD and CNS stimulant markets by offering alternative treatments or improving existing ones[4].
Key Takeaways
- Clinical Trials: Vallon Pharmaceuticals' ADAIR trial failed to meet its primary endpoint but showed promising results in secondary endpoints, indicating potential for abuse deterrence.
- Market Analysis: The ADHD market is expected to decline due to patent expiries and generic launches, but growing awareness of adult ADHD and new product launches may mitigate this decline.
- Market Projections: The CNS stimulant drugs market, including dextroamphetamine, is expected to grow despite challenges from side effects and API shortages.
- Pipeline and Future Developments: New pipeline agents and future drug launches will continue to shape the market, offering potential improvements in treatment options.
FAQs
What was the outcome of Vallon Pharmaceuticals' Phase III SEAL trial for ADAIR?
The trial failed to meet its primary endpoint of Emax Drug Liking, although it showed positive results in secondary endpoints related to drug liking and intranasal irritability[1].
Who are the main players in the dextroamphetamine sulfate API market?
Key players include Johnson Matthey, Cambrex, Curia Global, Mallinckrodt Pharm, and several others[2].
Why is the ADHD market expected to decline between 2022 and 2032?
The decline is primarily due to patent expiries and the launch of generic products, which are preferred by payers over branded products[3].
What new products are expected to launch in the ADHD market by 2026?
Products such as Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR are anticipated to launch in the US market by 2026[3].
How will API shortages impact the ADHD market?
API shortages are expected to be resolved by 2027, which will help normalize the uptake of generic products and stabilize the market[3].
Sources
- Vallon's Anti-Abuse ADHD Drug Formulation Flunks Clinical Trial - Biospace
- Global Dextroamphetamine Sulfate API Market Research Report 2024 - Valuates Reports
- ADHD market forecast to decline by $1bn between 2022 and 2032 - Clinical Trials Arena
- The practice-changing drugs that will land in 2025 - Norstella
- CNS Stimulant Drugs Market - Companies, Size & Share - Mordor Intelligence
