Bionorica Steers U.S. Consumers To Natural Products Through Science

Natural product marketer Bionorica looks to science to convince parents about the efficacy of natural remedies for children while they become more aware of possible risks associated with OTC cough and cold formulas.

Though the U.S. mass market is inundated with products touting natural product claims, few offer scientific support for their efficacy and consumers are wary of their ability to work, Scott Bukow, president of the Germany-based firm's Bionorica U.S. division.

"In the U.S., you have anything and everything on the market, so it is very hard for consumers to differentiate what is what," Bukow noted during an April 1 interview.

"There's a huge awareness issue and there's a lot of confusion as to what to take and what not to take," he added, indicating that task becomes even more daunting when it comes to children's cold products.

Many parents are hesitant in turning to natural product remedies because there is a lack of scientific research supporting their efficacy and safety, he suggested.

Bionorica expects to help fill that void by launching its natural remedies in the U.S. mass market, beginning with the introduction last year of Sinupret for Kids, a product marketed to treat upper respiratory ailments in children.

"Whatever you put in your child's body should be safe, well-researched, around for a number of years with no side effects," Bukow said.

The firm believes it has carved a niche because its products are supported with scientific data as appropriate alternatives for consumers who struggle with whether to give children OTC cough and cold medications, which are under review by FDA.

In response to a 2007 citizen petition stating that nonprescription pediatric cold medicines are not safe or effective for children under 6 years old, FDA began considering revising its OTC cough/cold monograph and asked about switching the pediatric products to prescription status (¹ (Also see "Pediatric Cough/Cold “Reverse Switch” Will Not Increase Safety – CHPA" - Pink Sheet, 22 Dec, 2008.), p. 3).

The lead author of the petition, Josh Sharfstein, has since been appointed FDA principal deputy commissioner and is acting commissioner pending the confirmation of President Obama's nominee, Margaret Hamburg (see story p 3).

The petition led to a joint meeting of the Nonprescription Drug and Pediatric advisory committees, which recommended children up to 6-years-old should not use OTC cough/cold medicines, but said the products are safe for children 6- to 12-years old.

The industry has voluntarily revised pediatric cough/cold product labels to warn consumers not to give the drugs to children under 4 years of age and not to use antihistamine products to sedate a child.

Kids Still Getting Cough/Cold OTCs

Bionorica-commissioned research that Harris Interactive conducted in March found that although 90 percent of parents claim to be at least somewhat knowledgeable about the level of effectiveness and risks associated with children's OTC cough and cold products, 62 percent still give the products to their children.

The survey contacted 2,315 consumers 18 and older, including 633 who are parents or legal guardians of a child aged 17 or younger, according to the firm.

The survey also found a lack of knowledge among consumers on the risks associated with pediatric OTC cough and cold products - 16 percent of the public had not heard about the possible dangers.

According to the survey, 84 percent of the public say they are "at least somewhat knowledgeable" about where to find credible information about OTCs, and 70 percent cited the media and Internet as sources of information on the possible dangers of pediatric OTC medicines.

The survey also suggested that doctors are not communicating the possible risks of pediatric OTCs to patients - less than half (41 percent) of parents said doctors broached the topic with them.

While 60 percent of adults would be more likely to use a natural remedy if it was recommended by a doctor, 83 percent had never discussed natural remedies with a physician and only 27 percent had discussed the potential for dangerous drug interactions, according to the research.

More Stateside Expansion For Bionorica

While multiple Bionorica products are available online, so far only Sinupret is available at U.S. stores. Sinupret, made with European elder, common sorrel, cowslip, European vervain and gentian, is available in 30,000 stores including Wal-Mart, CVS, Rite Aid and Walgreens chains.

Bukow said the product is made with the "most widely recommended, scientifically tested nasal and sinus support formula" in Germany for children.

The firm will continue expanding distribution of the product in the U.S. and will introduce an adult version, Sinupret Plus, in the fourth quarter.

Sinupret Plus, recommended for adults and children 12 and older, contains the same extracts as the children's version, and is promoted to support the upper respiratory system and to strengthen the immune system and nasal passages.

The company plans later to introduce child and adult lower respiratory products under the brand name Bronchipret , according to Bukow.

Bronchipret for Kids will be available in tablets containing thyme and primrose and in a thyme and ivy syrup.

Tested in a multi-center study of 7,000 patients ages 4 to 12 in Germany, the product was found to demonstrate "significant clinical efficacy and excellent tolerability compared to synthetics and other plant-based products," according to Bionorica.

Bronchipret for adults and children 12 and older contains thyme and primrose in a formula also tested in double-blind, placebo controlled studies.

Bionorica also plans to introduce women's products under the Menopret brand. Menopret is a formula containing black cohosh to treat symptoms of menopause including night sweats, sleeplessness and irritability and mood swings.

Bionorica' s women's offerings also will include Cyclopret , a formula that contains chaste tree berry to treat symptoms associated with menopause, including irritability, moodiness, bloating and headaches, the firm claims.

- Eileen Francis