FDA NEEDS MORE DATA TO MAKE PRILOSEC AN OTC DRUG

STEPHANIE LOUGHRAN

WASHINGTON -- Prilosec, a prescription heartburn remedy, has reached an important goal in making the possible switch from prescription to over-the-counter use.

A joint Food and Drug Administration advisory panel here on Oct. 20 confirmed the safety and efficacy of Prilosec for over-the-counter use, according to Jim Coyne, senior manager of gastro-intestinal public affairs for AstraZeneca, the drug's manufacturer based in Wilmington, Del. However, he stressed the FDA needs more data before they could recommend final approval for OTC application.

The notion of the possible switch to OTC use excited some grocery retailers. John Beckner, director of pharmacy and whole health, Ukrop's Super Markets, Richmond, Va., said, "It's going to be a significant impact, a huge impact on over-the-counter sales and probably a negative impact on prescription sales."

"Prilosec would be a best seller for OTC, because it seems to be more effective and agrees with more people," said a pharmacy technician contacted at a Foodtown, Ocean Township, N.J. The technician also said the price decrease would make sales jump.

The drug has already made an impact as a prescription medication as the top-selling drug in dollar sales volume, reaching $4.4 million from July 1999 to June 2000, according to IMS Health, Westport, Conn. It is also the fifth most dispensed prescription on the market, accounting for 31,830 prescriptions from July 1999 to June 2000, said IMS Health.

"This is an important first step for AstraZeneca and Proctor & Gamble [the would-be marketing and distributing arm based in Cincinnati]," said Coyne. "It will be a good opportunity for P&G and AstraZeneca to sit down with the FDA in providing that additional information and move forward in the process."

Meanwhile, the $1.4 billion heartburn remedy category can expect a new entry with Pepcid Complete following the FDA's approval earlier this month.

The new OTC from Johnson & Johnson/Merck Consumer Pharmaceuticals, Ft. Washington, Pa., combines two medicines in one chewable tablet. The formula consists of a fast-acting antacid that neutralizes acid on contact and the acid-controller Pepcid AC to prevent the production of excess acid at the source while continuing to control acid for up to 12 hours. Coyne said Prilosec would fare well in the already crowded category of OTC stomach remedies. "Prilosec is in a different class of drugs than some other OTC heartburn drugs because it works in a fundamentally different way," he noted. Coyne explained the drug works at the final step where acid is produced regardless of the source, whereas other antacid medications work as acid blockers to only one receptor. Coyne also said one pill could provide 24-hour heartburn relief, an important aspect for consumers.

A P&G spokesperson said that with over 50 million heartburn sufferers in the U.S., Prilosec is the "gold standard."