Syntex Given OK to Sell Naprosyn Over the Counter : Medicine: The FDA approves a non-prescription version of the popular pain reliever, setting the stage for a competitive battle.
The Food and Drug Administration has approved a popular prescription arthritis drug for marketing as an over-the-counter pain reliever--a move that will cause competitive headaches for the makers of Advil, Tylenol and other pain remedies.
The drug, naproxen sodium, is the first non-prescription pain reliever to win FDA approval since ibuprofen a decade ago.
“Naproxen’s long record of use clearly indicated that the drug could be sold over the counter, provided the manufacturer modified its dosage and labeling,” FDA Commissioner David A. Kessler said Tuesday.
Manufactured by Syntex Corp. of Palo Alto, the drug has been sold by prescription in the United States under the brand name Naprosyn since 1976, mostly for arthritis and inflammation. The non-prescription version, to be marketed for Syntex by Cincinnati-based Procter & Gamble, will be sold under the brand name Aleve.
The FDA’s approval sets the stage for a spirited fight in the $2.3-billion-a-year over-the-counter pain reliever market. The Syntex-Procter & Gamble product will go up against such established ibuprofen brands as Advil, produced by American Home Products Corp., and Upjohn Corp.’s Motrin IB. Another competitor will be Johnson & Johnson’s Tylenol, whose active ingredient is acetaminophen.
“We’re in for a real marketing battle, and we want to do it the right way,” said Syntex Chairman Paul E. Freiman, explaining why his firm formed a joint venture with consumer giant P&G; in 1988 to seek FDA approval for a non-prescription version of Naprosyn.
Analysts said the marketing costs for Aleve will be steep enough to erase any profits from the sale of the product for the first few years. Freiman agreed with that view.
“It’s a different chemical compound than previous pain medicines, but you have to educate the consumer,” said Kristine E. Bryan, an analyst at S.G. Warburg & Co. in New York. “Just like any new branded entity, it costs a lot of money to gain that shelf space.”
Bryan estimated that Aleve will generate U.S. revenue of $250 million during Syntex’s 1995-96 fiscal year, but said the actual figure will depend on the success of P&B;’s marketing effort.
A spokeswoman for American Home Products said the company is “confident that Advil’s proven record of safety and efficacy will remain unchallenged by the introduction” of Aleve.
Syntex and Procter & Gamble will have exclusive rights to market the non-prescription drug for three years.
Syntex shares gained 37.5 cents to $16.375 in New York Stock Exchange trading Tuesday. The stock has traded as high as $23.250 during the past 52 weeks.
Naprosyn and another naproxen-based drug, Anaprox, generated $928 million, or 32%, of Syntex’s worldwide sales of $2.13 billion for its fiscal year ended July 31. Syntex’s patent for Naprosyn expired in December. Since then, more than half a dozen manufacturers have begun marketing generic versions of Naprosyn. To preempt its rivals, Syntex’s Hamilton Parma Inc. unit began marketing its own generic version of Naprosyn in August.
Freiman said the generic versions have caused a “rapid falloff” in sales for the more costly Naprosyn brand. Syntex expected a sales decline, but the rate has been “on the fast end” of its estimates.
The FDA’s announcement Tuesday was therefore welcome news for Syntex. It followed a recommendation in June by FDA advisory committees that naproxen sodium not be approved for non-prescription use. The panels were concerned that because the drug acts slowly, consumers might take too much. There was also concern about misuse of the drug by children and the elderly.
In approving the drug for non-prescription use, the FDA asked Syntex to reduce the daily dose, extend the time between doses and add label warnings for children and the elderly.
The FDA said naproxen sodium can be taken for headaches, colds, toothaches, muscle aches, backaches, menstrual cramps and arthritis, and to reduce fever.
