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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

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

slide2
---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

epidemics of unintentional drug overdose deaths in the united states 1970 2005
Epidemics of unintentional drug overdose deaths in the United States, 1970-2005

Prescription drugs

Crack cocaine

Heroin

2

slide5
Unintentional drug overdose death rates and total sales of prescription opioid painkillers by year in the United States

8

oxycontin abuse national
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

slide9

U.S. Summary Retail Drug Purchases in

Millions of grams

ARCOS--DEA

slide10

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

slide11
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

slide12

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%

the medical letter 9 17 01
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.”

oxycontin nda 1995
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

oxycontin nda cont
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

slide17

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

cr morphine vs oxycontin
CR morphine vs. OxyContin

Comparable

Efficacy & Safety

in Cancer

Heiskanen, Pain

Mucci-LoRusso, Eur Journ of Pain, 1998

Bruera, J Clin Oncol, 1998

slide19
Comparative efficacy and safety of long- acting opioids for chronic

non-cancer pain: a systematic review

J Pain Symptom Manage, 2003

Chou, et al

slide20
Risks and Benefits of

an “abuse resistant” OxyContin

slide21
Benefits:

Some Deterrence for abuse:

Reduced snorting & injection

risks of an abuse resistant oxycontin
Risks of an “abuse resistant” OxyContin

--risks of iatrogenic addiction in chronic

non-cancer pain patients when

taken exactly as prescribed

risks cont
Risks (cont)

Increased risks of addiction when

preparation is chewed rather than swallowed

risks cont1
Risks (cont)

Risks of inadvertent over-dose

and death

risks of abuse resistant oxycontin cont
Risks of abuse resistant OxyContin(cont)

Risks of a false sense of security, fueling increased opioid prescribing, increased availability, and increased public health problems.

risks cont2
Risks (cont)

Risks of the manner in which this drug

could be marketed and promoted

slide28
“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…”

purdue pharma oxycontin nda 1995
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

possible fda actions
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

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