China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the completion of all subject enrollment in a multi-center Phase III clinical study for its Ryaltris compound nasal spray (GSP301). This compound is under evaluation as a potential treatment for seasonal allergic rhinitis (SAR) in patients aged 12 years and older.
Design and Scope of the Phase III Study
The Phase III study, which is randomized, double-blind, double-simulation, and parallel-controlled, enrolled over 535 SAR patients aged 12 and above. The study’s objective is to assess the efficacy, safety, tolerability, and pharmacokinetics of GSP301 in adults and adolescents suffering from SAR.
GSP301: A Fixed Combination Therapy with Global Approvals
GSP301 is a fixed combination of olopatadine and mometasone, which received its initial approval in the US in January 2022. Following this, the compound has gained approvals in Australia, South Korea, Russia, the UK, and the European Union. The therapy’s global recognition underscores its potential impact on the treatment of SAR.-Fineline Info & Tech
