The company, based in Danville, VA, commissioned a study whose results were presented in poster form at the recent Scripps Annual Conference on Supplements in San Diego, CA.
The research, conducted by Medicus Research, an Agoura Hills, CA-based CRO headed by Dr Jay Udani, measured nasal airflow among participants who were exposed to a variety of commonly breathed-in antigens such as dust and pollen. Nasal airflow was measured against baseline.
More air = less inflammation
“Controlling allergies has been a topic of discussion for years. It’s been a complex and challenging phenomenon for scientists,” Udani said. “Through our clinical research studies, we were able to show that the product improved nasal airflow – and leads to less sneezing.”
The study used a measurement called peak nasal inspiratory flow rate (PNIFR), or how much air a subject can take in through the nose with each breath.
“The higher the flow rate, the more open your nasal passages are,” said Omar Javery, MD, co founder of the company and the partner who worked most closely on the formulation itself. “It’s a way to measure how inflamed your nasal passages are after exposure to a concoction of the most common nasal antigens, such as dust, mites, pollen and pet dander.”
Javery said the idea for the product—and the company—came from a brainstorming session with co-founder Zeeshan Kaba, who describes himself as an entrepreneur. The upshot? A bad allergy attack can ruin your weekend, but the commonly used medications had side effects for some users.
“There is a lot of interest on my part on this alternative therapies,” said Javery, who received his medical training in Atlanta and at Harvard in Boston. “I think it’s naive to ignore that part of medicine. We were thinking, what could we do besides the standard therapies? I started doing concoctions in my kitchen. Then we took it to a next level and hired a PhD chemist and an herbalist.”
The formula the team came up with relies on herbs like eyebright, nettle and elderflower. The team chose the lozenge delivery system because the product is designed to be taken up to 12 times a day as symptoms dictate and the honey lemon flavor made it a pleasing prospect and potentially boosting compliance, Javery said. The company enrolled the assistance of contract manufacturer ProPhase Labs that already had experience formulating lozenges.
Twenty healthy volunteers ≥ 18 years of age (all of whom completed the study) who complained of occasional environmental allergy symptoms were enrolled in the study. Study participants were required to have a minimum amount of nasal airflow at rest (PNIF ≥ 90 L/min nasal airflow) and to demonstrate a decrease in nasal airflow of at least 30 L/min following nasal antigen provocation challenge. Individuals with nasal polyps, chronic sinusitis, severe asthma, history of anaphylactic reactions, or any history of nasal or sinus surgery were excluded from the study.
The duration of the randomized, double-blind, placebo-controlled, crossover study (which, Javery said, is planned for publication) was 3 weeks and entailed 3 visits: an initial screening visit to determine enrollment, followed by a randomization visit where either product or placebo was assigned and administered, followed by a third crossover visit.
Product was administered 30 minutes prior to antigen exposure. PNIF measurements were performed prior to antigen exposure, followed by intervals outlined in the table 1. Visit 3 was performed in a similar manner, with whichever product was not assigned at visit 2.
The results found that the antigenic challenge resulted in a statistically significant reduction in both the active and placebo at 15 minutes, however the percent change was greater in the placebo group. The percent reduction from baseline remained statistically significantly lower at 30 and 60 minutes in the placebo group and was no longer statistically significant in the active group at 30 minutes. The conclusion was that Allergease reduced the expected drop in PINFR after antigen exposure and could hasten recovery.
Kaba said the immediate strategic plan for the company is to concentrate on its connection with consumers through various marketing initiatives.
“Last year we were in 13,000 retail outlets; this year we will grow to about 20,000 retail outlets. We did a lot of on-the-ground marketing. This year we have over 50 events that we will be sponsoring or participating in and we are sponsoring 13 minor league baseball teams,” Kaba said.
“I’ve always been somebody who enjoys building a company form the ground up and we just lucked into fining an idea that helps a lot of people,” he said.