The FDA issued a complete response letter (CRL) to Lipocine ($LPCN) for its testosterone replacement treatment, citing issues with the drug’s dosing algorithm for the label.
The regulatory agency sends a CRL when a new drug application cannot be approved in its present form.
In the notification sent to Lipocine, the FDA said the proposed titration scheme for clinical practice for the company’s LPCN 1021 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, the company said.
Lipocine has touted LPCN 1021 as a testosterone-replacement therapy for treating hypogonadism in men with the potential to both improve patient compliance and overcome inadvertent testosterone transference risk. It is a twice a day oral treatment versus the more common topical cream form on the market.
In recent years, the FDA began to zero in on low-T treatments, taking a hard look at controversial evidence that testosterone therapy can lead to elevated risks of heart attack and other events. In 2014, a panel of agency advisers voted 14-1 in favor of restricting such drugs to use only in specific medical conditions.
“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,” Dr. Mahesh Patel, chairman, president and CEO of Lipocine, said in a statement.
The company said it will request a meeting with the agency to get more information and work toward gaining approval of the drug.
An FDA panel sided against approval for Clarus Therapeutics' oral low-T treatment in 2014, pointing out that while the drug didn't seem any more dangerous than other testosterone replacements, the fact that it's a pill may make patients more likely to take more of it, putting them at greater risk of the cardiovascular events tied to the whole class.
-here’s the release