# Presentation: 408845

## FDA

- Anesthetic & Life Support Drugs
- 	Advisory Committee
- Sept. 10, 2003

- 			Art Van Zee,MD
- 			St. Charles Clinic
- 			St. Charles, Va.

## Susstained-release hydromorphone

- 		(Palladone)
- --Risks vs. benefits discussion

## Benefits

- Review
- 	sustained release opioids vs.
- 		IR opioids

##              Comparable

-              Comparable
-          Efficacy & Safety
- Hale  Clin J Pain 9/99    BACK PAIN
- Kaplan R J Clin Oncol 10/98  CANCER
- Stambauugh J.Clin Pharm 5/01  CANCER

## 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

## OxyContin---NDA---1995

- 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 been shown to be as good as current therapy, but has not been shown to have a significant advantage beyond reduction in frequency  of dosing.”
- 				--Curtis Wright,  MRO

## The Medical Letter—9/17/01

-    “OxyContin is a q12h controlled-release formulation of oxycodone that can be used effectively in the treatment of pain due to cancer, and occasionally, other types of chronic pain.  There is 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.”

## CR morphine vs CR oxycodone

- 		Comparable in
- 		Efficacy and Safety
- Heiskanen  Pain   10/97           CANCER
- Mucci-LoRusso  ’98                CANCER
- Bruera  J. Clin Oncol  10/98    CANCER

## 		    Comparable

-           CR hydromorphone (Q12hr)
- 		    Comparable
- 	    Efficacy and Safety
-   Hayes  Cancer   9/94              CANCER
-   Bruera  J. Clin Oncol   5/96   CANCER

## 			Comparable

- 					 (Q12hrs)
- 			Comparable
- 		Efficacy & Safety
-    Hagen   Cancer   4/97            CANCER

## Summary

- 1. IR opioids and SR opioids are
-     comparable in efficacy & safety
- 2. SR preparations appear comparable in efficacy & safety

## Benefits:

- ---CONVENIENCE
- 	of bid or qd dosing
- ---Convenience of less pills
- ---for patients intolerant to other
- 	opioid preparations

## Risks of sustained release

- 	hydromorphone
-   of addiction when taken as
-       prescribed-----Unknown
-   of addiction—when used
-       non-medically—recreationally
-   of overdose and death—high
-       potency opioid dosing-- one pill

##       RISKS of   CR hydromorphone

- Brief over-view of the promotion
-    and marketing of OxyContin
- ---”Aggressive” marketing for chronic non-malignant pain
- ---Aggressive marketing to primary
- 	care physicians

## OxyContin marketing (cont)

- -- Trivializing the risk of addiction for chronic
-     non-cancer pain
- --Use of sophisticated marketing
- 	data to target and influence
-     high opioid prescribing docs

## Slide 16

##         % above national average

- Counties      hydrocodone     OxyContin
- Tazewell,Va            545%                     456%
- Perry, Ky                 415%                      559%
- Logan,WVa             397%                      430%

-         % above national average

## Slide 18

## Slide 19

## Slide 20

## Slide 21

## Personal thoughts:

- Replication of OxyContin problem if “Indications” for use of Palladone, and marketing---are the same as OxyContin
- 2. Unrestricted use in cancer
- Restricted use to a “compassionate use” program
-     in chronic non-cancer pain