# Presentation: 762286

## Summary

- Oral PE at 10 mg:
- No more effective than placebo
- No systemic effects
- Poor oral bioavailability
- Dose-response studies needed
- TV ads – grossly misleading

## Phenylephrine Nasal Spray

**Dressler et al.  Ann Otol Rhinol Laryngol 1977;86:310. **

**n=10**

**n=16**

**n=15**

## Symptom Scores

**NOSTRIL FEELS CLEAR** – no difficulty at all in 	breathing through this nostril.
**ALMOST CLEAR** – can breathe through this nostril 	quite easily.
**STUFFY** – with some hindrance to breathing through 	this nostril, but not enough to make me 	uncomfortable.
**QUITE STUFFY** – nostril feels blocked, and it is not 	comfortable breathing through this nostril.
**VERY STUFFY** – can barely breathe through this 	nostril at all and have to breathe through my mouth 	much of the time.
**COMPLETELY BLOCKED** – cannot breathe through 	this nostril at all.

**Dressler et al.  Ann Otol Rhinol Laryngol 1977;86:310.**

## Symptom Score (% Difference)

*****

*****

*****

*****

**PL**

**PE**

*******p<0.005 PE v Pl**

**Dressler et al.  Ann Otol Rhinol Laryngol 1977;86:310.**

**(57)**

**(54)**

**(47)**

**(46)**

## Bickerman.  www.jacionline.org

**Bickerman.  www.jacionline.org**

**Thomas et al.  Br J Clin Pharmac 1991;32:705-11.**

**○ ****-- PPA**
**● ****-- PE**
**+ -- PL  **

**Approx 0.2 – 1.6 mg**

**Martinsson et al.  Eur J Clin Pharmacol 1986;30:427-31.**

**IV PE**

## Dose Adjusted AUCFree 3H-Phenylephrine

- Dose Adjusted AUCFree 3H-Phenylephrine

**ng.min**
**  ****mL**

**F=38%**

**n=4**

**n=3**

**Hengstmann et al.  Pharmacokinetics of 3H-phenylephrine in man.  Eur J Clin Pharmacol 1982;21:335-41. **

## 	Randy C. Hatton, PharmD, FCCP, BCPS Co-Director, Drug Information and    	Pharmacy Resource Center
   Shands at the University of Florida

   Clinical Professor, College of Pharmacy
   University of Florida 
   Gainesville, FL

- 	**Randy C. Hatton**, PharmD, FCCP, BCPS Co-Director, Drug Information and    	Pharmacy Resource Center
-    Shands at the University of Florida
-    Clinical Professor, College of Pharmacy
-    University of Florida
-    Gainesville, FL

## Hatton\PLAYER.HTM

- _[Hatton\PLAYER.HTM](file:///Hatton/PLAYER.HTM)_

## 	Jonathan Shuster, PhD
   Research Professor
	Division of Biostatistics
   Department of Epidemiology and Health 	Policy
   College of Medicine
   University of Florida 
   Gainesville, FL

- 	**Jonathan Shuster**, PhD
-    Research Professor
- 	Division of Biostatistics
-    Department of Epidemiology and Health 	Policy
-    College of Medicine
-    University of Florida
-    Gainesville, FL

## Shuster\PLAYER.HTM

- _[Shuster\PLAYER.HTM](file:///Shuster/PLAYER.HTM)_

## Schering Protocol P04579 – Change inNasal Sx Score Over 6 hr in Vienna Chamber

- Schering Protocol P04579 – Change inNasal Sx Score Over 6 hr in Vienna Chamber

**Placebo**

**PE – 12 mg**

**PSE – 60 mg**

**% Change**

**p=0.6**

**p=0.01**

**n=30**

**p=0.01**

**Clinicalstudyresults.org (unique ID P04579)**

**R,DB,CO**

## Schering Protocol P04822 – Average 6 hr Mean Change in Nasal Congestion in Canadian Chamber

**Placebo**

**PE 10 **

**M + L**

**% Change**

**p=0.2**

**n=127**

**p=0.007**

**Clinicalstudyresults.org (unique ID P04822)**

**R,DB,PAR**

**n=126**

**n=126**

**p=0.001**

**n=379 subjects**

## Summary

- Oral PE at 10 mg:
- No more effective than placebo
- No systemic effects
- Poor oral bioavailability
- Dose-response studies needed
- TV ads – grossly misleading

## Leslie Hendeles, Pharm.D.

**Leslie Hendeles, Pharm.D.**
**University of Florida**
**Health Science Center (Box 100486)**
**Gainesville, FL  32610-0486**
**Phone:  (352) 273-6027**
**Fax:  (352) 273-6120**
**Email:  hendeles@cop.ufl.edu**