Alar Pharmaceuticals has licensed its long-acting buprenorphine injection INDV-6001 (ALA-1000) to international pharmaceutical company Indivior (LSE/Nasdaq: INDV), which has commenced a multi-dose pharmacokinetic clinical trial in the United States. This trial will evaluate the pharmacokinetics, safety, and tolerability of multiple INDV-6001 injections in patients with opioid addiction, serving as a basis for dosing strategies in future Phase III studies, projected to run until October 2025.
This study is an open-label, multi-center trial comprising six experimental groups, with plans to recruit 122 adult patients suffering from moderate to severe opioid addiction. It aims to assess the clinical performance of transitioning from commercially available daily sublingual tablets or monthly injections to the INDV-6001 injection, investigating various dosing regimens and intervals.
Participants in Groups 1-4 will be patients who have not previously received long-acting formulations. After a 7-day treatment with the daily sublingual tablet SUBOXONE, Group 1 will receive a 600 mg INDV-6001 injection every three months; Group 2 will receive the same dose every two months; while Groups 3 and 4 will receive 250 mg or 100 mg INDV-6001 injections, respectively, each month. Groups 5 and 6 will include patients currently receiving monthly injections of SUBLOCADE, transitioning to INDV-6001 injections every three months or every two months, respectively.
The primary endpoint will be the pharmacokinetic parameters at steady state after subcutaneous administration of INDV-6001. Secondary endpoints will include the occurrence of adverse events during treatment and injection site tolerability. Given that opioid addiction treatment often requires a prolonged duration, the trial will also assess the rotation of injection sites (thigh and posterior upper arm) by participants. According to Indivior's announcement, the trial is expected to continue until October 2025, with plans to commence the Phase III clinical trial in the first quarter of 2026.
Resource (mandarin): 昱展長效鴉片類成癮新藥ALA-1000授權夥伴在美展開臨床III期前藥動試驗
