Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Regulatory Issues for Approval: File IND/Clinical Studies, File NDA, and Other Approval


Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.

For two of the pharmaceutical companies interviewed, the cost of funding the necessary clinical trials for obtaining FDA approval was seen as a minor barrier to cocaine pharmacotherapy development. However, the pharmaceutical company that reported that the science base was not a barrier also reported that the regulatory aspects of development would not preclude moving ahead, so long as the science base and the financial market potential were evident. Also, one of the VC firms interviewed stated that drug regulation would not be a barrier if the market potential of the drug was very favorable.