Naprosyn Sales Suffer a Setback : Pharmaceuticals: A prescription drug for pain relief has hit a snag with the FDA for over-the-counter use.
A popular prescription drug for pain relief that was expected to challenge the likes of Tylenol, Advil and Bayer aspirin for the $2.2-billion-a-year over-the-counter market suffered a setback Wednesday when government advisory committees recommended against non-prescription sales.
Palo Alto-based Syntex Corp. has been selling naproxen by prescription in the United States for 17 years and over-the-counter in Australia for a decade.
But the Food and Drug Administration’s two over-the-counter committees said they had “insufficient data to lead us to the conclusion that the drug was safe and effective enough for over-the-counter use,” FDA spokeswoman Susan Cruzan said.
The advisory vote, though not binding on the FDA, sent Syntex’s stock down $1.25 to close at $19.75 on the New York Stock Exchange in trading of more than 2 million shares.
The committees’ rejection “definitely came as a surprise,” NatWest Securities drug analyst Jack Lamberton said. “The company and most analysts suspected it would not have a problem being recommended for approval.”
Traditionally, the FDA has followed its committees’ recommendations.
Cruzan said the panels had concerns about naproxen’s proper dosage and particularly its effect on elderly users.
It was unclear Wednesday whether Syntex and its marketing partner, Procter & Gamble, would have to redo clinical trials of the drug--sold by prescription under the brand name Naprosyn--a potentially long and costly process, or simply repackage the data already submitted.
Syntex had signed the joint venture agreement with Cincinnati-based P&G; to market a weaker, over-the-counter version of the prescription formula for a variety of ailments, including headaches, backaches and muscular pain as well as minor arthritis pains.
Syntex, a pharmaceuticals firm, and Procter & Gamble declined to comment on the advisory vote until they could meet with FDA officials.
Timing is critical to Syntex because its patent on naproxen expires in December.
If it obtains FDA approval while the patent is in force, Syntex can sell the drug exclusively over-the-counter for three years.
But if the drug becomes available for generic sales first, it will be extremely difficult for Syntex to sell a non-prescription formula at a reasonable price, analysts said.
Syntex’s sales of Naprosyn totaled $745 million in 1992, or 36% of its overall 1992 sales of $2.1 billion, said Kristine Bryan, a drug analyst with S.G. Warburg of New York.
Syntex and P&G; were hoping that non-prescription naproxen would repeat the success of Advil, which until 1984 was a prescription drug based on the ibuprofen formula sold for relief of arthritis pain. American Home Products obtained FDA permission to sell it over the counter and sales now total about $300 million per year.
