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 Avinza Opana ER

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

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

OxyContin--NDA 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

IR morphine vs. CR morphine in Cancer Comparable Efficacy and safety Deschamps, J Pain Symptom1992 Walsh, Am J Clin Oncol, 1992

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

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

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

Patrick Stewart,

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

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

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

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

Advanced Dispensing System GW Pharmaceuticals

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