HEALTH

Researchers request FDA pull ineffectual decongestant off the market

BY Michael Johnsen

GAINESVILLE, Fla. – Two University of Florida pharmacy researchers earlier this week called on the Food and Drug Administration to remove phenylephrine off the market, not because of any contrary side effects necessarily, but because the decongestant is ineffective. 
 
In an editorial published in the September/October issue of The Journal of Allergy and Clinical Immunology: In Practice, Randy Hatton, a clinical professor of pharmacotherapy and translational research, and Leslie Hendeles, a professor of pharmacotherapy and translational research and professor of pediatrics, concluded that oral phenylephrine is ineffective at treating nasal congestion.
 
The editorial accompanies research findings published in the same journal from a study led by Eli Meltzer of the Allergy & Asthma Medical Group & Research Center in San Diego. The study found that phenylephrine is no more effective than placebo in easing nasal congestion caused by allergies in adults. The study, which evaluated 539 adults with seasonal allergic rhinitis during seven days of treatment, failed to identify a dose of phenylephrine in the range of 10 mg to 40 mg that was significantly more effective than placebo. 
 
Approved OTC labeling recommends taking 10 mg of this non-prescription decongestant every four hours for temporary relief from nasal congestion.
 
“Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective,” Hendeles said. “Patients who seek an over-the-counter remedy should get what they pay for: an effective and safe alternative to a prescription drug.”
 
Phenylephrine gained popularity in the mid-2000s after federal legislation restricted the sale of pseudoephedrine-containing products. Congress moved PSE products behind the counter to curb diversion of the OTC in making illegal methamphetamine. 
 
“I was director of a drug information center in a hospital at the time, and doctors and patients would call me and ask, ‘What is the right dose of phenylephrine?’” Hatton said. “We did not have an answer, but we determined through scientific evidence that the 10-milligram dose was insufficient.”
 
Hatton and Hendeles, along with Almut Winterstein, a professor of pharmaceutical outcomes and policy at UF, conducted a systematic analysis of previous studies and eventually petitioned the FDA to require better proof of efficacy and to reconsider the appropriate dosage of phenylephrine. The FDA convened its Nonprescription Drugs Advisory Committee and after much debate, ultimately requested a dose-response study of the treatment of nasal congestion. Hatton said Meltzer’s research was long overdue and reaffirmed the position that non-prescription oral phenylephrine provided little-to-no relief of nasal congestion.
 
“We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed,” Hatton said. “We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people.”
 
Instead of oral phenylephrine, Hatton and Hendeles suggest patients consider using non-prescription oral PSE, nasal steroids for allergic rhinitis or topical decongestant sprays for nasal stuffiness from a cold or allergies. They contend these alternatives will ultimately provide relief to the millions of Americans who suffer from nasal congestion every year.
 
 
 
 
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Goody’s headache powders gain traction

BY Richard Monks

TARRYTOWN, N.Y. — With eight SKUs on the market and a high-profile stock car driver endorsing its products, Prestige Brands’ line of Goody’s internal analgesics is continuing to gain traction with consumers.

(To view the full Category Review, click here.)

According to IRI data, the brand was one of only a handful in the internal analgesic tablet category to record a sales increase over the past year, increasing 6.5% to $39.4 million.

In a conference call with investors in August, Prestige Brands president and CEO Ron Lombardi cited two factors that have helped fuel that growth — Goody’s tie-in with NASCAR and driver Dale Earnhardt Jr., and the recent launch of two new products.

The debut earlier this year of a mixed-fruit flavored headache powder, the brand’s third headache powder, and a back and body shot that complements the headache relief shot already in the company’s lineup are in keeping with Prestige’s strategy of developing new products to grow its brands, Lombardi said.

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Sleep-pain formulas provide relief

BY Richard Monks

For many people, sleep does not always come easily. Pain and a host of other problems can often make it difficult — if not impossible — to fall asleep. Temporary sleeping problems, in turn, can cause a tired mind and lead to headaches and body pains that make it even harder to get a good night’s sleep.

(To view the full Category Review, click here.)

According to the National Institutes of Health, about 70 million people suffer from a chronic sleep disorder or intermittent sleep problems. Researchers say that a majority of this sleeplessness is the result of headaches, backaches, muscle aches, minor arthritis pain or menstrual cramps.

Sleeplessness and its resulting aches and pains have helped drive sales of nighttime pain relievers that provide short-term relief of the headaches and minor aches and pains that can accompany the inability to fall asleep.

According to IRI data for the 52 weeks ended Aug. 9, four analgesics brands designed to provide nighttime relief rank among the top 20 in the category. Together, the quartet of products — Pfizer’s Advil PM, Bayer Healthcare’s Aleve PM and McNeil Consumer Healthcare’s Tylenol PM and Motrin PM — accounted for $180.4 million, or 5.5%, of the analgesics tablets’ $3.3 billion in sales during the period.

In addition, Bayer has offered Midol PM in the feminine pain reliever category for almost a decade. Bayer said the product is formulated with a maximum-strength pain reliever and a non-habit forming sleep aid to provide relief from occasional sleeplessness associated with menstrual cramps, backache, muscle aches and headache.

While the sales of nighttime analgesics are only about a quarter of the sales of OTC sleep aids, the suppliers of these products said these dual-purpose formulas represent an important niche in the pain relief market.

“For consumers who suffer pain-related sleeplessness, Advil PM combines the No. 1 pain reliever with a soothing sleep aid,” she said. “[It] provides a healing night’s rest by helping you fall asleep fast, stay asleep longer and it’s non-habit forming.”

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