About Fast Track Designation
According to the FDA, in order to be granted Fast Track designation, a drug must (1) be intended for the treatment of a serious or life-threatening condition; and (2) demonstrate the potential to address unmet medical needs for the condition.
A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
- More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials;
- Accelerated Approval , i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit;
- Rolling Review, which means that a sponsor can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed; and
- Priority Review, with an FDA goal for completing review within eight months of submission.
About MN-166 Clinical Development in AddictionClinical development of MN-166 is ongoing in both methamphetamine addiction and opioid addiction. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. A Phase 1b clinical trial of MN-166 in methamphetamine dependence is near completion at UCLA. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine dependence, led by investigators at UCLA, has been funded by NIDA. In opioid addiction, a Phase 1b clinical trial of MN-166 in heroin-dependent volunteers was completed at Columbia University/New York State Psychiatric Institute. A NIDA-funded Phase 2a clinical trial of MN-166 in opioid dependence is currently ongoing and led by investigators at Columbia University and the New York State Psychiatric Institute.