Role of Pharmacovigilance in Drug Repurposing

Pharmacovigilance plays a crucial role in drug repurposing by monitoring and assessing the safety profiles of existing medications when used for new therapeutic indications. This process involves the collection and analysis of adverse event data from real-world use and clinical studies to ensure that repurposed drugs do not pose unexpected risks to patients. By leveraging existing safety data and continuously monitoring new evidence, pharmacovigilance helps to mitigate potential safety concerns, optimize benefit-risk profiles, and support regulatory decision-making in the context of drug repurposing, ultimately contributing to patient safety and public health.

1. Welcome Pharmacovigilance-Based Drug Repurposing Fareed Pharm.D www.clinosol.com | follow us on social media @clinosolresearch 1 19/08/2024

2. Index What is Drug repurposing? Introduction The Challenge: Traditional Drug Development The Promise of Drug Repurposing Solution Real-Life Examples Conclusion 19/08/2024 www.clinosol.com | follow us on social media @clinosolresearch 2

3. What is Drug repurposing? www.clinosol.com | follow us on social media @clinosolresearch 3 Definition: Drug repurposing is the process of identifying new medical uses for existing drugs. It involves studying how a drug’s known mechanisms of action might benefit other conditions beyond its original intended use. Purpose: The primary goal is to expedite the availability of treatments for diseases by repurposing drugs that have already been tested for safety and efficacy in other conditions. This can be particularly valuable when addressing urgent medical needs or when developing new treatments for rare or complex diseases. 19/08/2024

4. Pharmacovigilance, traditionally focused on evaluating adverse drug effects to ensure patient safety, has emerged as a significant player in drug repurposing. Drug repurposing involves finding new therapeutic uses for existing drugs, and pharmacovigilance data can be instrumental in this process. By analyzing adverse event reports and other pharmacovigilance data, researchers can uncover novel uses for drugs that are already on the market www.clinosol.com | follow us on social media @clinosolresearch 4 Introduction 19/08/2024

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6. The Challenge: Traditional Drug Development Drug development is known for its complexity and cost: Lengthy Process: Developing a new drug typically takes over a decade, from initial discovery through clinical trials to regulatory approval. High Costs: The process can cost billions of dollars, considering the resources required for research, development, and clinical testing. High Failure Rate: Many new drugs fail during clinical trials due to inefficacy or unexpected adverse effects. Given these challenges, leveraging existing drugs for new purposes presents a compelling alternative. Existing drugs have known safety profiles and established manufacturing processes, which can streamline the development process for new indications www.clinosol.com | follow us on social media @clinosolresearch 6 19/08/2024

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8. The Promise of Drug Repurposing 1. Mining Big Datasets Pharmacovigilance Data: Monitoring adverse drug reactions generates extensive datasets that include information about the safety and efficacy of drugs. These datasets often contain valuable insights that can be used to identify new therapeutic indications. Data Analysis: By analyzing adverse event reports, researchers can discover previously unknown drug–event combinations that might suggest new uses for a drug. This can lead to identifying drugs that may be effective for conditions other than their original indications. 2. Four Approaches to Drug Repurposing Serendipity: Sometimes, valuable drug repurposing opportunities arise by chance. For example, sildenafil (Viagra) was initially developed to treat hypertension but was later found to be effective for erectile dysfunction. Mechanistic Profiling: This involves using a drug based on its observed pharmacological effects. For instance, sulfonylureas were initially developed to treat diabetes but were repurposed due to their hypoglycemic effects. Signature Matching: Researchers examine the characteristics shared among approved drugs to identify new therapeutic indications. This approach looks for patterns or “signatures” that suggest a drug might be effective for different conditions. Inverse Signaling: This method involves evaluating existing drugs for a range of conditions based on their known mechanisms of action. Current research is exploring repurposing drugs for conditions such as Raynaud’s phenomenon, COVID-19, and Alzheimer’s disease. 3. Advantages of Drug Repurposing Time and Cost Savings: Repurposing drugs with established safety profiles can significantly reduce the time and cost associated with bringing a new treatment to market. The drug's safety and dosing information are already known, so only efficacy needs to be demonstrated. Risk Reduction: Utilizing drugs with existing safety data reduces the risk of discovering new adverse effects, as the safety profile of the drug is already well understood. Patient Benefit: Drug repurposing can lead to the rapid introduction of new treatment options, potentially benefiting patients who have limited choices or who need new therapies. www.clinosol.com | follow us on social media @clinosolresearch 8 19/08/2024

9. Real-Life Examples Sildenafil (Viagra): Initially developed as a treatment for hypertension, sildenafil was found to be effective for erectile dysfunction, leading to its successful repurposing and commercialization in this new indication. Thalidomide: Originally infamous for causing birth defects when used as a sedative, thalidomide was repurposed to treat multiple myeloma and leprosy, demonstrating its potential in different therapeutic areas despite its troubled past. Metformin: Initially used to treat diabetes, ongoing research is exploring metformin’s potential in cancer prevention and longevity. Its widespread use and established safety profile make it a candidate for further investigation into new therapeutic roles. 9 19/08/2024

10. Conclusion Pharmacovigilance-based drug repurposing offers a promising strategy for expanding the therapeutic applications of existing drugs. By leveraging data from adverse event monitoring and other pharmacovigilance activities, researchers can uncover new indications for drugs that have already proven their safety. This approach not only helps address the high costs and long timelines associated with traditional drug development but also provides patients with potentially new and effective treatment options. Embracing drug repurposing allows us to harness the wisdom of experience and discovery to improve patient outcomes and advance therapeutic innovation. As Sir James Black once said , “The most fruitful basis for discovering a new drug is to start with an old one.” By applying pharmacovigilance insights to drug repurposing, we can continue to find innovative solutions and enhance patient care. www.clinosol.com | follow us on social media @clinosolresearch 10 19/08/2024

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