new OTC for asthma-Airozin from Pilot THerapeutics
Can asthmatics benefit from an OTC medical food? Pilot Therapeutics Holdings Inc., Charleston, S.C., thinks so. It is launching Airozin, an over-the-counter medical food for the dietary management of asthma. The product will be available initially in targeted markets in North and South Carolina in April.
Floyd Chilton, president/CEO of Pilot Therapeutics, told Drug Topics, "If you are an asthmatic, you have two to three times higher levels of compounds called leukotrienes than your nonasthmatic counterparts. Airozin reduces levels of blood leukotrienes in asthmatics and is an OTC medical food that regulates whole blood leukotrienes through dietary means."
Chilton said Airozin is available in two SKUsone for children ages six to 11, the other for patients ages 12 and up.
Airozin will be sold in packages containing 14 individual daily doses. Chilton said Airozin is a patented, clinically optimized formulation of gammalinolenic acid and eicospentaenoic acid, two fatty acids found in nature that help control whole blood leukotriene.
This liquid emulsion comes in an orange-peach-mint flavor in a once-a-day foil packet. Consumers can open the packet and squeeze the contents into their mouth or place the contents in water or juice.
The product has been evaluated in five clinical trials at major medical centers, and results have been reported in seven peer-reviewed publications. "This product has been demonstrated to reduce leukotrienes, substances known to give rise to the signs and symptoms of asthma," said Chilton. "I discovered this product while I was at Johns Hopkins University and subsequently at Wake Forest University School of Medicine. The product initially was discovered by placing 230 people in a hospital setting and controlling the fatty acids they take into their body to see if we could control mediators and inflammation."
AC Nielsen Market Decisions will distribute Airozin. "Based on what we learn after we obtain consumer and physician acceptance and volumetric projections of the product, we will take the product nationally," Chilton said.
Airozin will be introduced in a TV commercial in local markets, and consumers will be offered coupons for the product. Chilton said the company will detail physicians and pharmacists and will provide educational literature.
"If you are selling a medical food," Chilton said, "you have to meet an underlying need in a disease population, and the product has to be used under supervision of a physician. We are labeling the product to make sure people adhere to that. There's an educational process consumers will have to go through, and pharmacists can play a critical role in that education."
In conducting research, Pilot Therapeutics found that mothers of asthmatics are concerned about using steroids to treat their asthmatic children. "Mothers of asthmatic children ranked our product a 4.9 on a 5-point scale [5 being the best]. We're not saying this product is to replace any other product. It is adjunct therapy that would be used in conjunction with other therapies for the dietary management of asthma," Chilton said.
Chilton would not disclose the suggested retail price of Airozin, but he did say the product would fit in the cough and cold section of drugstores, food stores, and mass-merchandisers.
Sandra Levy. This new OTC for asthmatics plays up dietary management.