Producer positions PPA for regulatory approval

Pensacola, Fla.- PRN Pharmacal is urging the Food and Drug Administration (FDA) to fully approve phenylpropanolamine (PPA) as a new animal drug and pledges $2 million to study it for exclusive label rights - a move that's caught the attention of at least one manufacturing competitor.

Pensacola, Fla.-based PRN is one of three pharmaceutical companies marketingPPA products to treat urinary incontinent dogs. In January 2001, FDA officialspulled the drug from the market after a study linked its presence in dietarysupplements and nasal decongestants to hemorrhage stroke cases in women.Consequently, veterinarians lost their off-label PPA sources.

But it wasn't long before PRN and at least two other manufacturers, Europe-basedVétoquinol and Veterinary Products Laboratories (VPL) out of Phoenix,Ariz., resumed PPA production. As PRN received regulatory discretion withthe FDA's Center for Drug Evaluation and Regulation (CDER) to manufacturethe PPA drug Proin, so did Vétoquinol and VPL, which market Propalinand Cystolamine, respectively.

PRN representatives suggest widespread need for PPA in the companionanimal market, citing urinary incontinence in nearly 20 percent of all spayedfemale dogs.

"We knew when PPA was removed from over-the-counter human productsthat this would put many dogs at risk," says Gary Cushing, PRN vicepresident of sales. "Many pet owners will only put up with so muchdribbling. So PRN made the decision to finance the testing that would berequired to keep Proin PPA available for veterinary use."

Facing the competition

Of course, the companies each have their own marketing literature. WhilePRN officials maintain the company is "by far the market leader"in PPA sales with Proin effective in more than 94 percent of dogs tested,Vétoquinol representatives challenge the competitor's claims. Bothprivate companies won't publicize actual sales data, but Vétoquinolspokesman Rich Shavelson says his company has long-remained the world'sPPA production leader with its most recent addition of U.S. and Canadianveterinary markets.

"We're by far the largest marketer worldwide," he says. "Itis registered in every country in the world and presently under regulatorydiscretion for the U.S. We definitely think we've got a good product.

"Our mission is to educate the client. We have better selling aidsand educational materials than our competitors."

VPL representatives did not return phone calls seeking comment.

Race to label?

PRN spokesman Matt DeWeese admits the regulatory process likely willtake several years before Proin is fully approved for veterinary use, butinsists "the company will get a label on it."

In the meantime, Shavelson says he's not too concerned.

"We were going to try and get it approved, but when we found out(PRN) was doing it, we figured 'what's the point?'" he says. "Urinaryincontinence in dogs is huge; it's like a mini heartworm market. It'll takeyears before the FDA makes any decisions on this." n

PPA FOR SALE

n No less than three pharmaceutical companies manufacture phenylpropanolamine,commonly known as PPA, in the United States as a treatment for urinary incontinencein dogs. For years, the drug was prescribed off-label by veterinarians beforethe Food and Drug Administration (FDA) removed it from the human drug marketin 2001. Since then, federal drug regulators have temporarily reprievedPPA for veterinary use only. The following is currently available:

Proin, manufactured by PRN Pharmacal, Pensacola, Fla. The drug comesavailable in 75-milligram, 50-milligram and 25-milligram liver-flavoredchewable tablets and 25-milligram drops. Package sizing ranges from 60-countto 180-count bottles.

Cystolamine, manufactured by Veterinary Products Laboratories, Phoenix.The drug comes in 75-milligram capsules packaged in 60-count and 500-countbottles.

Propalin, manufactured by European company Vétoquinol. The drugcomes 60-count bottles of 25-milligram chewable tablets as well as 30-milliliterto 100-milliliter syrup vials.