Altasciences

HUMAN ABUSE POTENTIAL

Altasciences has conducted over 50 human abuse potential (HAP), abuse deterrent formulation (ADF), or substance abuse studies since 2008, including through repeated multi-year contracts with the NIH and the FDA. HAP studies may be required by the FDA as part of the safety evaluation for New Chemical Entities (NCEs) that are CNS-active, chemically or pharmacologically similar to other drugs with known abuse potential, or produce psychoactive effects such as sedation or euphoria. ADF trials are often pursuant to a 505(b)(2) or Hybrid strategy. The complicated regulatory pathway for HAP and ADF protocol designs (selection of comparator, recruiting, etc.) requires individualized consulting for each type of study.