2021/11/09 Alar Announce Results from ALA-1000 Single Ascending Dose Study in Opioid Dependent Patients
TAICHUNG, November 09, 2021 / — Alar Pharmaceuticals Inc. (6785.TWO) announced the positive results of single-ascending-dose study assessing safety, tolerability, and pharmacokinetics of ALA-1000 in opioid dependent patients. A total of 59 patients were enrolled in the study conducted at a single clinical center in the US. 46 subjects met the completer criteria for the 27-week study period. All drug-related AEs were mild or moderate in severity and were consistent with what is to be expected for subjects experiencing opioid withdrawal and known pharmacology effects of buprenorphine. The most commonly reported adverse events deemed treatment-related were
2021/10/28 Alar Pharmaceuticals Inc. Completes Successful End-of-Phase 2 Meeting with US FDA for ALA-1000 for the Treatment of Opioid Use Disorder
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