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Analgesic Drug Development for Chronic Pain A Brief to DAAODP & AAC July 29, 2002

Analgesic Drug Development for Chronic Pain A Brief to DAAODP & AAC July 29, 2002. Najib Babul, PharmD TheraQuest Biosciences nbabul@theraquestinc.com. Conflict of Interest Statement. Pharmaceutical sponsors with submissions or pending submissions before Divisions 550 and 170.

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Analgesic Drug Development for Chronic Pain A Brief to DAAODP & AAC July 29, 2002

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  1. Analgesic Drug Development for Chronic PainA Brief to DAAODP & AACJuly 29, 2002 Najib Babul, PharmD TheraQuest Biosciences nbabul@theraquestinc.com

  2. Conflict of Interest Statement • Pharmaceutical sponsors with submissions or pending submissions before Divisions 550 and 170. • Views expressed are solely those of TheraQuest Biosciences TheraQuest

  3. Analgesic Drug Development: Regulatory Framework FDA • Guideline for the Evaluation of Analgesic Drugs (December, 1992) EMEA • Guidance on Clinical Investigation of Medicinal Products for Treatment of Pain (CPMP Draft, November 2001) TheraQuest

  4. Supportive Guidelines • Clinical development programs for drugs, devices and biological products intended for the treatment of osteoarthritis (FDA Guidance, July 1999) • Clinical investigation of medicinal products used in the treatment of osteoarthritis (CPMP PTC, July 1998) TheraQuest

  5. Gaps in Regulatory Framework • Multidose evaluation in acute pain • Slow-onset drugs with utility in acute pain • Drugs for neuropathic pain • Drugs for cancer pain • Guidance for CLBP, fibromyalgia, myofascial pain • Chronic pain as an indication TheraQuest

  6. Potential Models of Chronic Pain • Myofascial pain • Low back pain • Osteoarthritis • Fibromyalgia • Mixed-model population • Neuropathic pain* • Cancer pain* TheraQuest

  7. Response Assessment in Chronic Pain: Challenges • Diverse etiology • Heterogeneous population within diagnosis • Referral patterns • Psychological overlay • Disability payments and litigation • “Unrealistic” outcomes expectations TheraQuest

  8. It has recently been suggested that replicate evidence in 3 chronic pain states (models) may be required for a chronic pain indication …. What are the potential implications of this?

  9. Chronic Pain Indication • Do we have three well established and robust models of chronic pain? • Replicate evidence for a specific sub-indication may be appropriate • Replication in two models of chronic pain OR robust and internally consistent evidence in single trials in three models may be reasonable • If burden is too high for a broad indication, will we get sub-indications, with attendant off-label use? TheraQuest

  10. Additional Issues • Use of co-primary endpoints - Pain, function, global - Some precedence in OA - Increased statistical burden? - Unrealistic pharmacologic expectation for complex disorders? • Placebo-control vs. active control • Clinimetric flexibility TheraQuest

  11. Important Considerations • DAAODP and DACCADP face somewhat different issues: - Abuse liability, neuropathic pain - GI and CV outcomes, inflammatory pain, disease modification • However, “harmonized” development guidelines may help assure cost-effective development, parity and timely patient access • Sponsors with clinical development/submissions underway may need special considerations

  12. Analgesics Drug Development for Chronic PainA Brief to DAAODP & AACJuly 29, 2002 Najib Babul, PharmD TheraQuest Biosciences nbabul@theraquestinc.com

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