Lipocine announced the dosing of the first subject in the ambulatory blood pressure (ABPM) clinical study for Tlando, the company's oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. This study was initiated after receiving FDA feedback on the ABPM clinical study protocol and is being conducted to definitively characterize Tlando's blood pressure effect, if any.
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"We are pleased to have dosed the first subject in the ABPM study for Tlando, which is expected to provide data by year end. We expect this additional data will address the blood pressure related concern cited in the Complete Response Letter," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.