Reviva Pharmaceuticals, Inc., a privately owned drug innovation and formulation company, today introduced enrollment of patients within its phase 2 clinical study of RP503 for schizophrenia and schizoaffective dysfunction. The aim of this randomized, double-blind, placebo-controlled, four-arm, worldwide multi-center Phase 2 study would be to determine the efficacy, security and tolerability of RP5063 in female and male affected individuals with schizophrenia. The trial intentions to enroll 228 affected individuals from the USA, Philippines, India, Malaysia and Russia. The firm demands to report outcome of this Phase 2 clinical study for RP5063 over the end of the year.
Outcomes from the Phase 1 clinical study of RP5063 performed in America in 55 Caucasian and Asian topics, both healthy members and schizophrenia affected individuals indicated that in fact drug is well tolerated by using a very favorable safety profile, foreseeable pharmacokinetics adequate for once-daily oral dosing schedule. The 32-patient Phase 1b multiple ascending dose (MAD) trial confirmed excellent acknowledgement by subjects in addition to activity in disorder stabilization and cognition. The foremost frequent antagonistic event ended up being mild to average nausea; however no patient reduced from the trial on account of negative effects. At the Positive and Negative Syndrome Scale (PANSS), there is an overall a considerable effect for therapy vs. placebo of the Positive Factor Score. Furthermore, there were also favorable developments in other indications for instance anxiety/depression and impulsivity/hostility.
Neuropsychologist Dr. John Harrison stated "These outcomes recommend that RP5063 could have the tendency to aid executive functionality and, on the flip side to older antipsychotics, is to this point will not cause cognitive negative effects."
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