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

09/12/1997

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
 

Strategy

Case Study Drugs
  Naltrexone  
LAAM Trexan ReVia Clozapine Nicorette
Discovery          
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
   
Marketing          
Mandated coverage      
✓ HCFA(now known as CMS) mandated coverage
 
Source: The Lewin Group