Sudafed

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Sudafed is a brand name and registered trademark for a family of over-the-counter (OTC) decongestants based on pseudoephedrine hydrochloride and manufactured by Pfizer Inc. for sale in the United States and United Kingdom.

Switch to phenylephrine

In late 2004, Pfizer started publicly disclosing its plans to make available a new OTC product, Sudafed PE, which does not include pseudoephedrine. Sudafed PE contains a different decongestant called phenylephrine, in a formulation sold for years in Europe. The new product became available on January 10, 2005. Sudafed products which combine the decongestant with other ingredients will be completely converted to phenylephrine later in 2005, though original Sudafed will still be offered.

The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products. State laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to produce the illegal and highly addictive stimulant methamphetamine.

Pfizer and its predecessor Warner-Lambert had studied at least two alternatives to its current formula in anticipation of pressure from state regulators and the Food and Drug Administration:

In 1996, the company began testing a patented decongestant ingredient known as "minus" pseudoephedrine. The company claimed animal tests showed this altered version offered sinus relief comparable to the current "plus" pseudoephedrine. The difference was that it couldn't be converted to meth. Pfizer did not bring the new ingredient to market back then because of the cost and time involved in gaining regulatory approval.
Pfizer spent $12 million trying to develop additives for Sudafed that might make it harder to remove the pseudoephedrine it contains. They abandoned the project in 2003, seven years after announcing its existence.

According to L. Hendeles of the University of Florida, "Phenylpropanolamine, pseudoephedrine, and phenylephrine are the most common decongestants. Although all are sympathomimetic amines, their efficacy varies. In particular, phenylephrine is subject to first-pass metabolism and therefore is not bioavailable in currently recommended doses."[link]

External links and sources

[Sudafed® Nasal Decongestant], a summary from the manufacturer
[Sudafed maker cuts meth ingredient], a December 2004 article from CNN
[Remedy that defies meth will join market], a December 2004 article from The Oregonian
[Meth bill may get 2nd look in state], a November 2004 article mentioning Sudafed PE from the Des Moines Register
[Walden seeks FDA help on meth], a November 2004 article from the office of U.S. Representative Greg Walden
[Was the West's methamphetamine epidemic allowed to happen?], a five-part series published in The Oregonian in October 2004

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