The US Food and Drug Administration (FDA) has refused to approve Lipocine's Tlando, an oral testosterone product candidate for testosterone replacement therapy (TRT).
The specialty pharmaceutical company had submitted a new drug application, seeking approval for Tlando as TRT for adult males with conditions caused by deficiency of endogenous testosterone (hypogonadism).
Lipocine received a complete response letter (CRL) from the regulator, citing multiple deficiencies.
One of the deficiencies as per the FDA is the lack of establishing the extent, if any, of ex vivo conversion of testosterone undecanoate (TU) to testosterone (T) in serum blood collection tubes to confirm T data’s reliability.
The regulator also found deficiency on the company’s part in collecting definitive evidence pre-approval through an ambulatory blood pressure monitoring study as to whether its oral testosterone product candidate demonstrated a clinically meaningful increase in blood pressure in hypogonadal males.
The application was alo found to be short on verifying the reliability of Cmax data and giving justification for non-applicability of the agreed-upon and prespecified Cmax secondary endpoints for Tlando.
It also identified that the application did not determine the suitable stopping criteria that can reproducibly and accurately identify those patients who should stop use of Tlando.
Earlier, this year, an FDA committee had decided not to recommend approval of Tlando with a majority of the panel members voting against the benefit/risk profile of the oral testosterone product candidate.
Lipocine chairman, president and CEO Mahesh Patel said: "While we are disappointed by the FDA's decision, the deficiencies identified in the CRL are within our expectations following the meeting we had on January 10, 2018 with the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the FDA.
“We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies. We remain committed to work with the FDA to bring Tlando to patients.”
Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.