Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Existing Government Strategies to Lower Market Barriers


The government was involved in aspects of development and marketing for each of the four case study drugs. These phases, adapted from the 1995 IOM report, include discovery, clinical studies, NDA phase, and marketing.

Figure 23: Overview of Past Government Strategies to Lower Market Barriers


Case Study Drugs
LAAM Trexan ReVia Clozapine Nicorette
Funding of basic science research
✓ for Nicorette and other nicotine replacement therapies
Clinical Studies          
Funding of clinical trials
✓ through NIDA
✓ through NIDA
✓ through NIAAA
NDA Phase          
Fast-track approval
✓ given informally
not known
not known
✓ given informally
✓ given informally
Orphan drug status
✓ small market size
✓ small market size
Other market exclusivity    
✓ 3-years post-approval
✓ due to lengthened approval process
✓ limited exclusivity for both the prescription and OTC forms
Less stringent phase IV clinical trial requirements    
✓ requirements based on annual prescriptions
Mandated coverage      
✓ HCFA(now known as CMS) mandated coverage
Source: The Lewin Group