LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions related with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
It is designed to help restore normal testosterone levels in hypogonadal men.
The agency sent a Complete Response Letter (CRL) regarding the company’s New Drug Application (NDA) informing that it cannot be approved in its esisting form.
The CRL found deficiencies associated to the dosing algorithm for the label.
The proposed titration scheme for clinical practice was identified to be significantly different from the titration scheme used in the phase 3 study resulting in discordance in titration decisions between the specified trial and real-world clinical practice.
Lipocine is assessing the content of the CRL, including the actions recommended by the FDA to bring its NDA in a position for approval.
The company said it work with the FDA to identify the appropriate next steps for the NDA.
Lipocine chairman, president and CEO Mahesh Patel said: "We continue to believe that LPCN 1021 has the potential to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners that exist with topical gels."