Testosterone Replacement Therapy Rejected by FDA

The FDA has sent a complete response letter to Lipocine for its potential oral testosterone product.

If it’s ever approved by the FDA, LPCN 1021 would serve as testosterone replacement therapy for men with a deficiency or absence of endogenous testosterone, which is also known as hypogonadism.

The rejection letter from the FDA noted deficiencies in the dosing algorithm for the label.

“Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the phase 3 trial leading to discordance in titration decisions between the phase 3 trial and real-world clinical practice,” Lipocine wrote in a press release.

The manufacturer plans to meet with the FDA to resolve the issues so that LPCN 1021 can be approved.

“We remain committed to bringing LPCN 1021 to patients who will benefit from its intended use,” said Mahesh Patel, chairman, president, and CEO of Lipocine, in a press release. “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.”

The product candidate would be a twice-daily oral therapy. Currently, most of the available products on the market for hypogonadism are short-acting injectable products or topical products that carry black box warnings, Lipocine noted.