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news.Lipocine(LPCN), a specialty pharmaceutical company, has announced the completion of the last patient visit in the safety assessment portion of its Study of Oral Androgen Replacement (SOAR) pivotal Phase III clinical study evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone (Low T).
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Lipocine previously announced positive top line efficacy from the SOAR clinical study in September 2014 and expects to announce top-line results from the 52 week safety assessment portion of the SOAR clinical study by mid-year as well as file the New Drug Application (NDA) with the US Food and Drug Administration in the second half of this year.
"Completion of the last patient visit has Lipocine positioned well to file our New Drug Application with the Food and Drug Administration in line with our previous guidance," said Dr Mahesh Patel, chairman, president and CEO of Lipocine.
Dr Patel further stated, "We are pleased to report that no drug or cardiac related adverse events were observed during this one year study and look forward to sharing top-line results from this safety portion of the study."
The current testosterone market is dominated by topical products that are associated with poor patient compliance and FDA "black box" warnings related to inadvertent transfer of testosterone.
LPCN 1021 is a twice-a-day, oral product candidate with three simple oral dosing options that we expect will overcome the major shortcomings of existing products.