US-based specialty pharmaceutical company BioPharmX has received approval from Health Canada to undertake phase 4 study of its Violet molecular iodine supplement for treatment of fibrocystic breast condition (FBC) and cyclic mastalgia.
Last month, the company that develops products for use in dermatology and women’s health received US FDA approval from to perform the study in the US.
To conduct the study, BioPharmX has selected KGK Synergize, an Ontario, Canada-based clinical research organisation focused on nutraceutical, biotechnology and pharmaceutical product research.
Under the randomised, double-blind, placebo-controlled and multi-centre study, the safety, tolerability and potential benefits of the molecular iodine dietary supplement, Violet, on breast health in women with cyclic breast pain and tenderness, will be assessed.
Results from the study are expected by the end of this year.
BioPharmX clinical and regulatory affairs executive vice president AnnaMarie Daniels said: "At least 875 million reproductive-age women around the world suffer from breast pain and discomfort due to fibrocystic breast condition.
"Previous studies have shown that molecular iodine results in a significant reduction in the symptoms of FBC.
"The goal of this study is to learn more about the safety and potential benefits of molecular iodine to expand claims and support commercialisation of Violet iodine in international markets, where the number of women with this condition is expected to grow to over a billion by 2050."
Last month, the company had obtained institutional review board (IRB) approval to begin a phase 4 study of Violet molecular iodine supplement.
The sample size for this study is expected to cover 120 females, with around 80 subjects receiving Violet iodine and around 40 subjects receiving the placebo in a double-blind manner.