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The National Crisis of Prescription Opiate Abuse: How can the FDA respond?

The National Crisis of Prescription Opiate Abuse: How can the FDA respond?. Anesthetic & Life Support Drugs Advisory Committee March 29, 2007 Art Van Zee,MD St. Charles Clinic St. Charles, VA. Since the advent of the OxyContin tragedy— FDA approval of: Palladone

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The National Crisis of Prescription Opiate Abuse: How can the FDA respond?

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  1. The National Crisis of Prescription Opiate Abuse: How can the FDA respond? Anesthetic & Life Support Drugs Advisory Committee March 29, 2007 Art Van Zee,MD St. Charles Clinic St. Charles, VA.

  2. Since the advent of the OxyContin tragedy— FDA approval of: Palladone Avinza Opana ER

  3. Sustained release opioids vs.immediate release opioids Efficacy, safety and risks

  4. IR oxycodone vs CR oxycodone Comparable Efficacy & Safety Hale Clin J Pain ’99 BACK PAIN Kaplan J Clin Oncol ’98 CANCER Stambaugh J Clin Pharm ’01 CANCER

  5. OxyContin--NDA--1995 MEDICAL OFFICER REVIEW (MOR) Summary of Safety “ The best conclusion is that the efficacy of the CR (oxycodone) is equivalent to the IR, with an adverse event profile that is as good as the IR. I would not allow a ‘better’ claim” --Curtis Wright, MRO

  6. IR morphine vs. CR morphinein CancerComparable Efficacy and safetyDeschamps, J Pain Symptom1992 Walsh, Am J Clin Oncol, 1992

  7. IR hydromorphone vs CR hydromorphone (Q12hr) Comparable Efficacy & Safety Hays Cancer ’94 CANCER Bruera J Clin Oncol ’96 CANCER

  8. Comparative efficacy and safety of long- acting opioids for chronic non-cancer pain: a systematic review J Pain Symptom Manage, 2003 Chou, et al

  9. Risks of sustained release opioids higher than IR opioids ---higher addiction risk when abused --higher risk of inadvertent over-dose and death

  10. Patrick Stewart, 1980-2004

  11. FDA Change the indications for sustained release opioids— ---available to all cancer patients ---in chronic non-cancer pain, available on a “compassionate” use program

  12. FDA set the standard that only opioid products that are abuse resistant could be brought to the marketplace

  13. FDA • An empowered FDA with more capacity and capability to review and regulate the marketing and promotion of controlled drugs

  14. FDA • require the use of a secure and tamper proof means of dispensing controlled drugs

  15. Advanced Dispensing System GW Pharmaceuticals

  16. FDA Have a meeting dedicated to review the pertinent issues of the opiate abuse crisis and craft a bold and meaningful response

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