This study for drug repositioning has been performed for the drugs which are in the market since more than a decade and they are approved with their well-established efficacy and safety in human being. Objective of this study was to reposition the existing non-cancer drug therapy for cancer treatment, which is having well characterized pharmacologic profile with more efficacy and least toxicity as anti-neoplastic agent. We have retrieved the source data from FDA Adverse Event Reporting System (FAERS) for the last 13 years covering duration from 2004 to 2016 and analysed those using pharmacovigilance approach ‘a proposed future novel pharmaceutical tool for drug reposition’. Signal management activity was performed for statistical analysis. Result of statistical analysis derived that propranolol; metformin; pioglitazone; dabigatran and nitroglycerin are the existing non-cancer drugs which deserved for their direct / indirect reposition for cancer treatment and anti-neoplastic activity. Further studies retrieving the source data from other regulatory database (e.g. Eudravigilance of EMA and VigiFlow of WHO) and post-marketing surveillance study with the same objective may adjuvant our results for the reposition of existing drugs by pharmacovigilance approach.

This study was aimed to find drug-repurposing opportunity of anti-diabetic drugs for treatment of neurodegenerative diseases using pharmacovigilance approach. We have retrieved the source data from United States FDA Adverse Event Reporting System for the last 15 years covering duration from 2004 to 2018. Medical dictionary for Regulatory Activities, version 19.1 was used to decode the relevant preferred terms for reported indications and side-effects. We have targeted reposition of anti-diabetic drugs for neurodegenerative disease. A primary target was set to identify anti-diabetic drug, which has therapeutic or prophylactic effect for neurodegenerative disease. Molecular mechanism of drugs and phenotypic characteristic of reported side-effects were compared with 'very common' side-effects of approved drugs for treatment of 'neurodegenerative disease'. Statistical analysis includes quantitative methods to calculate proportional reporting ratio for confirmed signal. Signals calculated with proportional reporting ratio value more than two, were only considered as positive result outcome. Through our systematic review of safety data, we have identified rosiglitazone, insulin (intranasal administration) and exenatide as convincing molecules for them reposition to treat neurodegenerative disease as novel therapeutic indication. Through this study, we have proposed to create a novel opportunity to find anti-diabetic drug that fully convinced for treatment of neurodegenerative disease. In future, well-designed, double-blind randomized controlled trials with large samples are required to conclude the efficacy of proposed reposition for anti-diabetic drugs.