The New Zealand-based over-the-counter therapy will be available for US patients on Amazon's website in 2018.
The US Food and Drug Administration (FDA) has approved an over-the-counter therapy cream for atopic dermatitis.
New Zealand-based company BioNona’s Atopis eczema therapy cream was approved by the FDA, improving on the product’s previous label as a “Dry Itchy Skin Relief Cream.”
The cream, containing novel compound myriphytaseis, has no steroids, parabens, or solvents. It created through a process the company calls “Peptilization,” which fuses components of plant, bacteria, and insects.
According to BioNona, it has been developed in research for over 30 years by chief executive officer Iona Weir, PhD. The natural cream spent another 7 years in development, but Weir called the eventual approval “so rewarding.”
“Now we are going into America, it can help even more,” Weir said. “The FDA accreditation is a coup for our company as well as for New Zealand.”
Weir said the cream contains nutrients extracted from ingredients such as bee pollen, coconut, honeydew, and bacteria from New Zealand forests. The intention of the ingredients is to create immunological response to attack areas affected by dermatitis and repair damaged cells, in a nature similarly seen in plants.
“I wanted to create something completely natural, but that could still get proven results from robust clinical tests on humans,” Weir said. “We’ve gone through the world’s most rigorous clinical testing to prove that this is a natural product which actually works.”
The treatment showed efficacy in New Zealand and US-based clinical trials, according to BioNona, and its primary compound is developed for treating psoriasis and acne, as well.
When the Atopis cream comes to US markets, it will be via Amazon. The shopping website will feature the treatment, as it already does many other over-the-counter therapies. By Weir’s count, about 50% of over-the-counter sales occur online through FDA-approved outlets such as Amazon.
In the annual US market, over-the-counter atopic dermatitis treatments amount to approximately $2 billion, Weir said.
The cream will come to US markets in 2018, according to BioNona. The company intends to pursue FDA consideration for an acne skin care treatment next.
A press release regarding the approval was made available.