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McNeil Motrin Migraine Pain, Aflexa Supplement National Ads Breaking Soon

This article was originally published in The Tan Sheet

Executive Summary

McNeil Consumer Healthcare's Motrin Migraine Pain is reaching food, drug and mass store shelves now; the product began shipping nationwide April 5.

McNeil Consumer Healthcare's Motrin Migraine Pain is reaching food, drug and mass store shelves now; the product began shipping nationwide April 5.

National TV, print and radio ads are expected to break in the next few weeks and will feature a new product tagline. Lowe Lintas is the ad agency of record.

Motrin Migraine Pain - the first ibuprofen-based migraine headache pain treatment approved for over-the-counter sale - comes in 24-, 50- and 100-caplet bottles, retailing for approximately $3.69, $5.79 and $7.79, respectively. Packaging features the same orange color used for other Motrin products.

Adults are directed to take one or two caplets for treatment of migraine headache pain, and not more than two in 24 hours "unless directed by a doctor."

"If symptoms persist or worsen, ask your doctor," states outer packaging, which carries the "Drug Facts" box as required under FDA's OTC labeling regs. Labeling also contains allergy alerts and pregnancy and breast-feeding warnings.

Consumers are advised to "Ask a doctor before use if you have never had migraines diagnosed by a health professional...a headache that is different from your usual migraines...the worst headache of your life," or "fever and stiff neck."

FDA, which approved McNeil's supplemental NDA for the migraine indication Feb. 25, has taken a cautious approach to labeling for OTC analgesics indicated for migraine.

Bristol-Myers Squibb's Excedrin Migraine (aspirin/ acetaminophen/caffeine), the first OTC cleared for a migraine indication, was approved in January 1998 for "Temporary relief of mild to moderate pain associated with migraine headache." In October 1999, BMS received approval for the broader indication "Treats migraine," referring to all migraine symptoms.

Whitehall-Robins received FDA clearance for Advil Migraine Liqui-Gels in March (1 (Also see "Advil Migraine Liqui-Gels" - Pink Sheet, 20 Mar, 2000.)). The product - 200 mg solubolized ibuprofen in liquid-filled capsules - will carry the claim "Treats migraine," which is less restrictive than Motrin's indication because it encompasses symptoms such as nausea and light/sound sensitivity.

McNeil consumer information pamphlets, entitled "Living with Migraine: Ways to Take Control," are available at retail outlets in free-standing displays near Motrin Migraine Pain.

The brochure lists five symptoms characterized by migraines: intense pain and throbbing usually on one side of the head; headaches accompanied by nausea or vomiting; sensitivity to bright light; sensitivity to loud noises and some odors, and diminished ability to work, study or be with others.

"If you answered yes to two or more of these questions, your headache may be a migraine. To find out for sure, write down your symptoms and talk to your doctor," the brochure advises. The pamphlet lists dietary, hormonal and lifestyle factors that can trigger migraine attacks and offers tips on exercise and healthy eating to avoid migraines.

Motrin Migraine Pain "provides an alternative for those who may be sensitive to the aspirin and caffeine ingredients found in some other over-the-counter migraine pain relievers," the pamphlet states.

McNeil also began nationwide shipments in early April of Aflexa, a glucosamine dietary supplement launched in Florida in January (2 (Also see "J&J Supplement Offerings Grow With McNeil Aflexa Launch" - Pink Sheet, 21 Feb, 2000.)). National TV, print and radio ads are expected in June; the ad agency is Saatchi & Saatchi.

Aflexa is expected to retail for approximately $13.99 for a 50-count bottle. The debut of the product in Florida, where McNeil said it performed well, also featured a 110-count bottle, as well as a 250-count size available in warehouse stores.

During the first quarter, Johnson & Johnson, McNeil's corporate parent, posted worldwide consumer sales of $1.75 bil., up 1.4% from the year ago period. U.S. consumer sales rose 1.7% to $943 mil., led by "continued strength" in the firm's skin care franchise.

American Home Products reported first quarter consumer health care sales of $595.9 mil., up 6% over a year ago. The firm attributed the increase primarily to higher sales of nutritional supplements, including Centrum vitamins and Caltrate, as well as Advil.

AHP's Whitehall currently is offering a free .75 oz. tube of Colgate Total Fresh Stripe toothpaste in 80-count boxes of Advil Liqui-Gels. Colgate-Palmolive approached Whitehall about the co-promotion, which began in January.

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