Alar Pharmaceuticals Inc. (abbreviated as Alar Pharm), a new drug development company focused on long-acting release drug products, has announced that it concluded its End-of-Phase 2 (EOP2) meeting with U.S. Food and Drug Administration (FDA) for ALA-1000 on October 27, 2021.
ALA-1000 is a long-acting new drug under development to treat opioid use disorder (OUD) with a particular dosing interval of subcutaneous injection once every three months.
Based on the findings from Phase I/IIb study, the EOP2 meeting focused on discussing the development plan of ALA-1000 for the proposed Phase III study and NDA submission, such as Chemistry, Manufacturing, and Controls (CMC), Phase III pivotal trial study design, and Phase III long-term safety study.
After the EOP2 meeting, US FDA agreed with the plans for Phase III clinical trials and provided feedbacks for preparing the NDA application. The outcomes of this EOP2 meeting support the advance towards Phase III pivotal study and future NDA submission.