2020/08/21 Alar Pharmaceuticals Inc. Completes Pre-IND Meeting with US FDA for ALA-3000

      Alar Pharmaceuticals Inc., a new drug development company focused on long-acting release drug products, has announced that it concluded its pre-Investigational New Drug (pre-IND) meeting with U.S. Food and Drug Administration (FDA) for ALA-3000 on August 21, 2020.

      ALA-3000 is a developing long-acting new drug to treat patients with treatment-resistant depression (TRD), which is designed with specific features to have safety benefits. In the written response, US FDA agrees with the development plans of Chemistry, Manufacturing, and Controls (CMC), nonclinical studies, and phase 1 clinical study for ALA-3000, and also provides feedback beyond the studies required for opening phase 1 study. The outcomes of this pre-IND meeting deem the development of ALA-3000 through 505(b)(2) regulatory pathway, and advance towards an IND submission.