Autism spectrum disorder (ASD) is a collection of development disorders of unknown etiology characterized by difficulties in social interaction, verbal and nonverbal communication and repetitive behaviors. In addition to social deficits, ASD can also result in intellectual delays, irritability, problems with motor coordination, and additional physical ailments including gastrointestinal issues. It is estimated that there are over 4M patients worldwide with ASD and the incidence rate is rising rapidly. The estimated lifetime healthcare and societal cost of ASD is $3.2MM per patient indicating a real need for effective ASD therapies. The therapeutic market for ASD is expected to grow to over $700M by 2017.
The two FDA approved therapeutics for ASD (Risperdal® and Abilify®) treat only the irritability component of ASD. As an NMDA receptor antagonist, memantine is thought to be able to treat additional ASD core characteristics including the social and communication deficits associated with the disorder. Dr. Hollander and colleagues validated the use of memantine to treat ASD and associated disorders in a pilot human proof-of-concept study. The self-reported outcomes indicated treatment with memantine improved social and communication deficits. Additional human clinical trials conducted by additional third parties are underway studying the safety and efficacy of memantine in ASD.
Current Development Status
- Initial human proof-of-principle studies completed (n=18; 17 had self-reported improvement in behavioral symptoms associated with ASD and associated disorders)
- Additional human clinical trials underway or completed by third parties
Applications
- Autism spectrum disorder
- Other impulsivity disorders such as obsessive compulsive disorder and attention deficit hyperactivity disorder
Advantages
- Memantine (Namenda®); FDA approved for Alzheimer’s disease
- Generic (available in tablet, extended release capsule, and liquid)
Publications
- Not available
Patent Status
- International Application PCT/US2005/033467 filed September 19, 2005
- Status: Published. International Publication No. WO 2006/034187 A2
- US Utility Application 11/575,483 filed March 15, 2007
- Status: Issued. US Patent No. 8,461,148
- US Continuation Application 13/912,402 filed June 7, 2013
- Status: Published. Publication No. 2014-0088083
Contact Information
Lisa Placanica, PhD
Business Development Director
Mount Sinai Innovation Partners | Icahn School of Medicine at Mount Sinai
Phone: 646.605.7325