PHARMACISTS APPLAUD ALEVE APPROVAL

JANICE ZOELLER

Supermarket pharmacists greeted the news that the Food and Drug Administration had approved low-dose naproxen sodium as a general-purpose analgesic with enthusiasm. Most think this latest switch from prescription to over-the-counter status will be a big seller.

The new OTC analgesic, named Aleve, contains 200-milligram naproxen and 20-milligram sodium. It was approved by FDA Jan. 11, and is being manufactured by Syntex, Palo Alto, Calif., and marketed by Procter & Gamble, Cincinnati. Aleve, which is a low-dose version of the prescription drug Anaprox, will be available "in the spring," according to the two companies, in bottles of 24, 50 and 100 tablets and caplets. Syntex/P&G will have three years' exclusivity to market naproxen sodium as an OTC analgesic.

The key to the success of this product in supermarkets with pharmacies will be the extent to which health and beauty care buyers and merchandisers work with pharmacists, say pharmacists and others.

"The switch will be beneficial for us because our pharmacists are already spending a lot of time on the health and beauty aids floor," said Mark Polli, director of pharmacy at Hannaford Bros., Scarborough, Maine. "It's a significant event. Our pharmacists will have another option to recommend to customers. Because our pharmacists are accessible, he or she will be a resource for customers to get any clarification they may need."

"It's going to be a big market," said Mark Caldwell, pharmacy coordinator at Haggen, Bellingham, Wash. He added that OTC naproxen sodium "will offer a real therapeutic benefit" for customers because it needs to be taken only twice a day.

"It will do well because of the compliance factor," added Jerry Zable, director of pharmacy at Gooding's Super Markets, Altamonte Springs, Fla. "People will be more willing to choose it for the same reason that they'll select a long-acting antihistamine over a short-acting one."

Aleve provides pain relief lasting eight to 12 hours. For adults and children age 12 and over it will be indicated for temporary relief of minor aches and pains associated with the common cold, headaches, toothaches, muscular aches, backaches, the minor pain of arthritis, menstrual cramp pains, and reduction of fever. Patients who are allergic to ibuprofen or aspirin are advised not to use Aleve.

Pharmacists expect they will get a lot of questions about this newest OTC analgesic ingredient. They are also gearing up to help their supermarket companies make the most of the naproxen sodium switch.

"It's always good for people to have more options," said Polli. "It's a matter of the information they receive surrounding those options, and that's where our pharmacists can be of value in answering questions, such as, 'What's the difference between naproxen and ibuprofen?' and make recommendations. Our pharmacists are going to be the key ingredient."

"I expect that we will handle the switch similar to Tavist and get the product in the stores quickly," said Glen Davis, director of pharmacy at Randall's Food Markets, Houston. "We'll be one of the first in Houston to have it out on the shelves." Davis said he was about to meet with his HBC counterpart to discuss the switch.

Caldwell also was preparing to alert his company's HBC buyers. "We'll probably do the same thing we did when ibuprofen went OTC," he said. "I was asked to talk about the drug at a meeting of variety managers, including how big of a product it was on prescription." "Our HBC people are aware that this switch has happened and they understand how big it is," said Polli, speaking only two days after FDA approved the switch. "They understand that this is a fourth ingredient in what has been a three-ingredient market up until now. The decision of where to stock the product hasn't been made. It will probably come out in a shipper and be located near the analgesic area. Eventually, it will be right in the section."

Despite the obvious need for the pharmacy and HBC departments to work together to make the switch a success for supermarkets, such cooperation is not a given.

One pharmacy director said he sometimes has difficulty convincing the HBC department to order new switches right away. Instead, products such as Tavist were ordered initially by the pharmacy and stocked in the pharmacy. Eventually, after the product took off, the HBC department "woke up" and took it over.

Pharmacy consultant Ed Heckman, who is president of Heckman & Associates, Chicago, said supermarkets are often "slow on the draw" when it comes to switches, and wait to see what the drug chains will do. "Whoever gets market share first," he stressed, "usually has a better time of holding it."

Heckman said supermarket pharmacies need to promote more and link promotion of switches to the pharmacy. "Merchandise it under the professional direction of the pharmacist," he advised. "Advertise the connection of the product to the pharmacy. Have pharmacists available to help patients choose the right product."

Supermarkets can expect help in understanding the significance of this latest switch from the General Merchandise Distributors Council.

Ronald Turner, GMDC's vice president of member affairs and education, said the association was preparing to alert its 105 supermarket member companies about the naproxen sodium switch.

"We have asked manufacturers such as Procter & Gamble to produce what we call a store bulletin, which is a selling message about the switch's attributes and history, including its past performance on prescription, so food store executives can readily see the impact and know when it's shipping, to make sure the product is coming to their store."

The idea, said Turner, is to get this information to supermarket headquarters and to stores before the product actually ships. "We want to have as many people ready at retail, excited for that first ship date."

Pharmacists said that the main use for OTC naproxen sodium is likely to be for menstrual cramps. They also expect that the new analgesic will take sales from ibuprofen.

"I see it diluting sales of the current OTC analgesic products," said Zable. "It may take share from ibuprofen. There are only so many sales out there."

"It's going to give ibuprofen a run for its money," said Caldwell.

The impact also will be felt in prescriptions for Anaprox and Naprosyn, said pharmacists.

"We should see the naproxen market impacted and definitely the Anaprox market," said Zable, "but probably no more than ibuprofen was. We still see prescriptions for ibuprofen." A lot will depend, he said, on whether third-party plans continue to cover Naprosyn and Anaprox. Zable has alerted pharmacy managers not to build substantial inventory of Anaprox.

Pharmacists have some concern over the safety of having a product such as naproxen sodium available for general use.

"I think that there is a potential for gastric upset, even severe gastric upset with both ibuprofen and naproxen," said Caldwell, "but naproxen is not as hard on the kidneys as ibuprofen, so there is some advantage there."

Naproxen sodium is only the fourth ingredient to be available as an OTC analgesic, the other three being aspirin, acetaminophen and ibuprofen. Pharmacists also can expect the entire category to gain visibility as manufacturers of competing products try to blunt Aleve's impact with advertising and promotions of their own.

Aleve will be sold in a child-resistant package called Safety Squease, developed by Procter & Gamble. Aleve bottles of 24 and 50 tablets and caplets will feature a fold-out label attached to the container.

Observers expect Aleve will be priced lower than on prescription, but higher than other comparable OTC analgesics.