Clinical Studies

Spectrix utilizes proprietary multi-particulate technologies to improve current drug therapies. The strategy for gaining FDA approval for these novel drug products is through a New Drug Application (NDA) using the 505(b)(2) regulatory pathway. This pathway allows for Spectrix to reference prior drug approvals that provide information about the active pharmaceutical ingredient and its prior use. This regulatory approach is efficient, in terms of time and expense, in gaining approval of an NDA for a branded pharmaceutical product.