BioPharmX Corporation Initiates Post-Market Phase
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Posted On: 03/22/2016 8:53:20 AM
BioPharmX Corporation Initiates Post-Market Phase IV Study for Fibrocystic Breast Condition (FBC) and Cyclic Mastalgia
Study to evaluate the impact of Violet® molecular iodine on reducing frequency and severity of cyclic breast discomfort and improvement in health-related quality of life
MENLO PARK, Calif., March 22, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for use in dermatology and women's health, today announced it has received institutional review board (IRB) approval to initiate a Phase 4 study of its Violet® molecular iodine supplement for fibrocystic breast condition (FBC) and cyclic mastalgia.
KGK Synergize, a London, Ontario based clinical research organization focused on nutraceutical, biotechnology and pharmaceutical product research, will conduct the study. The study is randomized, double-blind, and placebo controlled to evaluate the safety, tolerability and potential benefits of the molecular iodine dietary supplement, Violet, on breast health in women with cyclic breast pain and tenderness.
The planned sample size for this study is 120 females, with approximately 80 subjects receiving Violet iodine and approximately 40 subjects receiving the placebo in a double-blind manner. Participants will be instructed to take Violet iodine or placebo daily for six months. Participants receiving placebo in the first study phase will be offered three months of Violet iodine at the conclusion of their participation in the six month study period. Participants will record symptoms daily using a smart phone app and complete a more in-depth on-site questionnaire and receive a blood draw prior to the study, at three months, and again at six months. Results from this study are expected by the end of 2016.
"A significant number of American women suffer from breast discomfort due to fibrocystic breast condition," said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX Corporation. "The goal of this study is to learn more about the safety and potential benefits of Violet."
Study to evaluate the impact of Violet® molecular iodine on reducing frequency and severity of cyclic breast discomfort and improvement in health-related quality of life
MENLO PARK, Calif., March 22, 2016 /PRNewswire/ -- BioPharmX Corporation (NYSE MKT: BPMX), a specialty pharmaceutical company developing products for use in dermatology and women's health, today announced it has received institutional review board (IRB) approval to initiate a Phase 4 study of its Violet® molecular iodine supplement for fibrocystic breast condition (FBC) and cyclic mastalgia.
KGK Synergize, a London, Ontario based clinical research organization focused on nutraceutical, biotechnology and pharmaceutical product research, will conduct the study. The study is randomized, double-blind, and placebo controlled to evaluate the safety, tolerability and potential benefits of the molecular iodine dietary supplement, Violet, on breast health in women with cyclic breast pain and tenderness.
The planned sample size for this study is 120 females, with approximately 80 subjects receiving Violet iodine and approximately 40 subjects receiving the placebo in a double-blind manner. Participants will be instructed to take Violet iodine or placebo daily for six months. Participants receiving placebo in the first study phase will be offered three months of Violet iodine at the conclusion of their participation in the six month study period. Participants will record symptoms daily using a smart phone app and complete a more in-depth on-site questionnaire and receive a blood draw prior to the study, at three months, and again at six months. Results from this study are expected by the end of 2016.
"A significant number of American women suffer from breast discomfort due to fibrocystic breast condition," said AnnaMarie Daniels, executive vice president of clinical and regulatory affairs at BioPharmX Corporation. "The goal of this study is to learn more about the safety and potential benefits of Violet."
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