Abstract
Introduction
Two drugs have progressed through the pipeline representing the first two products to receive US FDA approval for use as adjunctive therapies to stimulants: Intuniv (extended release guanfacine; Shire) and Kapvay (clonidine; Shionogi). Interest in the ADHD pipeline remains high as companies continue to attempt to demonstrate differentiation in the increasingly competitive market.
Features and benefits
• Understand key R&D dynamics in the pipeline for new ADHD therapies.
• Benchmark novel and existing therapies using the target product profile identified by Datamonitor.
• Support R&D decision making by evaluating clinical trial designs that have set a precedent.
• Evaluate the most promising new pharmacological targets in early-stage development.
• Access Datamonitor' s prediction of how the treatment landscape may change in the next 20 years.
Highlights
The ADHD drug pipeline has almost doubled since 2008 with 25 candidates in clinical development. Although large and medium sized Pharma are present, the pipeline is dominated by smaller companies that will need licensing partners to bring their products to market.
Trends in the ADHD drug pipeline indicate a growing interest in non-stimulant agents used as add-on therapies to stimulants, with around a quarter of non-stimulants under investigation for adjunctive use. Datamonitor sees this is as a viable market entry point amid high competition.
Increasingly, companies view the adult ADHD population as a more viable target than pediatric ADHD due there being less competition, increasing disease awareness, and fewer challenges in conducting clinical trials.
Your key questions answered
• What are the key trends in the ADHD pipeline?
• What key companies are involved in the pipeline? What encourages and deters companies from investing in this area?
• What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?
• How is the treatment of ADHD likely to evolve over the next 10 to 20 years?
Table of Contents
Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
CLINICAL PIPELINE OVERVIEW
Overview of the ADHD clinical pipeline
Datamonitor has identified 25 candidates in clinical development
Emerging features of the ADHD pipeline
Activity in the ADHD pipeline indicates moderate yet growing industry interest in the market
The number of candidates in development for ADHD has almost doubled since 2008
Phase II is the most populous phase of development
Varied modes of action are being explored, with clear emphasis on non-stimulant mechanisms
Almost one quarter of non-stimulants are under investigation in combination therapies with stimulant medications
Oral formulations continue to dominate the pipeline
Developers are increasingly targeting adult ADHD
Companies involved in the ADHD clinical pipeline
Small specialist pharmaceutical companies dominate the clinical pipeline
Large market players are involved across all phases of clinical development
Late-stage development compounds recently discontinued
Seven candidates in the late-stage ADHD pipeline have been discontinued since 2009
TARGET PRODUCT PROFILE
Adderall XR (mixed amphetamine salts extended release; Shire)
Strong clinical profile and approval for ADHD patients across lifespan makes Adderall XR the most appropriate comparator therapy for both stimulant and non-stimulant medications
Clinical trial data for Adderall XR
Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN ADHD
Clinical trials
Lack of published regulatory guidance on the conduct of clinical trials in ADHD
Typical trial design in ADHD
Commonly used primary clinical trial endpoints in ADHD
Secondary clinical trial endpoints in ADHD
Key challenges in the conduct of clinical trials in ADHD
Future developments in clinical trial design
Size of clinical trials will increase in an attempt to demonstrate efficacy of adjunct therapy with stimulants
Companies will attempt to demonstrate efficacy of adjuncts with lower stimulant doses
Further development of outcome measures that are relevant to adult patients
Functional outcomes and QOL are increasingly important endpoints for product differentiation
INNOVATIVE EARLY-STAGE APPROACHES
Abuse resistant formulations
Reducing substance abuse concerns with stimulant drugs would confer a commercial advantage in ADHD market
Phosphodiesterase inhibitors
Novel mechanism targeting cognition, memory, and motor behavior in ADHD
THE FUTURE OF TREATMENT IN ADHD
The use of adjunctive therapies in ADHD is expected to increase
Identification of likely responders will aid physician selection of treatment of combination therapies
Obtaining reimbursement will be a growing concern, impacting the potential uptake of add-on therapies
Future commercial opportunities lie in reducing the pill burden associated with adjunctive therapies
Amendments to ADHD diagnostic criteria of the upcoming DSM-V
Proposed changes have the potential to increase adult ADHD patient population and create new indications
Biomarkers for ADHD
Biomarkers may have utility in identifying appropriate patients and improving treatment outcomes
Pharmacogenetics and neuroimaging are biomarkers under clinical investigation
Reduced R&D spending has commercial appeal, and a competitive advantage is a bonus
BIBLIOGRAPHY
Journal papers and publications
Websites
Datamonitor reports
APPENDIX
Contributing experts
Conferences attended
Report methodology
