FDA Public Meeting on Patient-Focused Drug Development for Chronic Pain
FDA is interested in hearing patients' perspectives on chronic pain, views on treatment approaches, and challenges or barriers to accessing treatments for chronic pain. FDA is particularly interested in hearing from patients who experience chronic pain
that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.
Topics for Discussion at the Public Meeting
Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to Patients
1. How would you describe your chronic pain? (Characteristics could include location, radiation, intensity, duration, constancy or intermittency, triggers etc.)
2. What are the most significant symptoms that you experience resulting from your condition? (Examples may include restricted range of motion, muscle spasms, changes in sensation, etc.)
3. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your chronic pain? (Examples of activities may include work or school activities, sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
4. How has your chronic pain changed over time? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)
Topic 2: Patients' Perspectives on Current Approaches to Treatment of Chronic
1. What are you currently doing to help treat your chronic pain? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies.)
a. How has your treatment regimen changed over time, and why? (Examples may include change in your condition, change in dose, or treatment side effects.)
b. What factors do you take into account when making decisions about selecting a
course of treatment?
2. How well does your current treatment regimen manage your chronic pain? (Considerations include severity and frequency of your chronic pain and the effects of chronic pain on your daily activities.)
3. What are the most significant downsides to your current treatments, and how do they affect your daily life?
4. What challenges or barriers to accessing or using medical treatments for chronic pain have you or do you encounter?
5. What specific things would you look for in an ideal treatment for your chronic pain?