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Art Van Zee, M.D. St. Charles Clinic St. Charles, VA

FDA Joint Meeting of Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees, May 5, 2008 Re: NDA 22-272, OxyContin. Art Van Zee, M.D. St. Charles Clinic St. Charles, VA. ---Review the over-all context: the national prescription opioid problem

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Art Van Zee, M.D. St. Charles Clinic St. Charles, VA

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  1. FDAJoint Meeting of Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees, May 5, 2008Re: NDA 22-272, OxyContin Art Van Zee, M.D. St. Charles Clinic St. Charles, VA

  2. ---Review the over-all context: the national prescription opioid problem ---Review efficacy & safety OxyContin in relation to other available opioids ---Review risks & benefits of an an “abuse resistant” OxyContin ---Possible FDA responses

  3. Unintentional drug overdose deaths by specific drug type, United States, 1999-2004 4

  4. Epidemics of unintentional drug overdose deaths in the United States, 1970-2005 Prescription drugs Crack cocaine Heroin 2

  5. Unintentional drug overdose death rates and total sales of prescription opioid painkillers by year in the United States 8

  6. OxyContin abuse: national Prevalence of abuse nationally OxyContin>hydrocodone>other oxycodone> methadone>morphine>hydromorphone OxyContin abuse the most prevalent Cicero, Inciardi, Munoz. Trends in abuse of OxyContin & other opioid analgesics in the U.S. 2002-2004. J. Pain, 2005

  7. Availability

  8. Opioid Abuse Data

  9. U.S. Summary Retail Drug Purchases in Millions of grams ARCOS--DEA

  10. Quantity of Controlled Substances in the Supply Chain TOTAL DISPENSED PRESCRIPTIONS 2006 2007 Hydrocodone 129,675,900 135,465,900 Oxycodone 42,292,200 45,878,100 Hydromorphone 1,835,400 2,139,200 Fentanyl 7,040,000 7,307,900 Methadone 3,779,000 4,037,000 Alprazolam 39,313,500 41,267,200 IMS Health, C. Gallagher, DEA, Diversion Control 3.08

  11. Quantity of Controlled Substances in the Supply Chain TOTAL DOSAGE UNITS DISPENSED 2006 2007 Hydrocodone 8,096,081,600 8,567,331,900 Oxycodone 2,731,569,000 3,075,119,400 Hydromorphone 144,180,900 166,964,500 Fentanyl 88,028,400 92,017,000 Methadone 495,391,000 528,081,000 Alprazolam 2,380,796,700 2,507,373,600 IMS Health, C. Gallagher, DEA, Diversion 3.08

  12. Reported Source of Pain Relievers by Past Year Users Aged 12 or Older: 2006 Note: Totals may not sum to 100% because of rounding or because suppressed estimates are not shown. 1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.” Source Where Respondent Obtained Drug Dealer/Stranger3.9% Bought on Internet0.1% Source Where Friend/Relative Obtained Other14.9% More than One Doctor 1.6% More than One Doctor3.3% Free from Friend/Relative7.3% One Doctor 19.1% Free from Friend/Relative55.7% Bought/Took fromFriend/Relative4.9% OneDoctor 80.7% Bought/Took from Friend/Relative14.8% Drug Dealer/Stranger1.6% Other 12.2%

  13. How does OxyContin compare in efficacy and safety to other available opioids?

  14. The Medical Letter---9/17/01 “…..no evidence that oxycodone offers any advantage over appropriate doses of other opioids, and it appears to have the same potential for addiction as morphine.”

  15. 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 profile that is as good as the IR. I would not allow a ‘better’ claim.” --Curtis Wright, MRO

  16. OxyContin NDA (cont) Summary of efficacy “CR oxycodone appears to be a BID alternative to conventional QID oxycodone. Approval is recommended. Care should be taken to limit competitive promotion. This product….has not been shown to have a significant advantage beyond reduction in frequency of dosing.” --Curtis Wright, MRO

  17. 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

  18. CR morphine vs. OxyContin Comparable Efficacy & Safety in Cancer Heiskanen, Pain Mucci-LoRusso, Eur Journ of Pain, 1998 Bruera, J Clin Oncol, 1998

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

  20. Risks and Benefits of an “abuse resistant” OxyContin

  21. Benefits: Some Deterrence for abuse: Reduced snorting & injection

  22. Risks of an “abuse resistant” OxyContin --risks of iatrogenic addiction in chronic non-cancer pain patients when taken exactly as prescribed

  23. Risks (cont) Increased risks of addiction when preparation is chewed rather than swallowed

  24. Risks (cont) Risks of inadvertent over-dose and death

  25. Patrick Stewart, 1980-2004

  26. Risks of abuse resistant OxyContin(cont) Risks of a false sense of security, fueling increased opioid prescribing, increased availability, and increased public health problems.

  27. Risks (cont) Risks of the manner in which this drug could be marketed and promoted

  28. “Recovery of morphine from acontrolled-release preparation: a source of opioid abuse”Crews JC; Denson DD CANCER Dec. 15, 1990 “…over the past 18 months, MS-Contin has surpassed hydromorphone…as the most desirable and abused prescription opioid in this area…”

  29. Purdue Pharma OxyContin NDA 1995 68% of the oxycodone could be extracted from an OxyContin tablet when crushed Purdue Pharma, NDA OxyContin, 1995 Pharmacology Review, Abuse liability of oxycodone

  30. Possible FDA Actions • “Abuse resistant” OxyContin to REPLACE,NOT SUPPLEMENT the current preparation • FDA to have much enhanced over-sight over the marketing 3. To re-evaluate and revise the indications given for SR opioids

  31. Possible FDA responses (cont.) • Special called meeting of FDA to formulate new strategies and changes to impact the prescription opioid abuse problem

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