SAN DIEGO—LCPN 1021, a novel oral testosterone formulation, demonstrates a favorable safety and tolerability profile for the long-term treatment of hypogonadal men, study data presented at the American Urological Association’s 2016 annual meeting show.

Notably, the phase 3 study, which previously established the drug’s efficacy in raising testosterone levels, found that LCPN 1021 causes no liver toxicities, a well-recognized problem associated with oral testosterone preparations. The formulation bypasses the liver and is absorbed mainly by the lymphatic system.

The drug is now before the FDA, which on June 28 is expected to rule on the manufacturer’s request for marketing approval.

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Approval of the drug could mark an important advance in the treatment of hypogonadism in men because it would avoid the potential danger of transferring testosterone to family members and others, as is potentially the case with testosterone gels, patches, and implants.

In a 52-week phase 3 open-label randomized trial comparing LCPN 1021 with an active control (testosterone gel [T gel]), a team led by Mohit Khera, MD, of the Baylor College of Medicine in Houston, found comparable rates of adverse events (AEs) in both treatment arms: 67% of LPCN 1021 patients and 65% of T gel patients. No hepatic, cardiac, or drug-related serious AEs occurred, Dr. Khera said.

The study included 315 men: 210 randomized to receive LPCN 1021 twice daily and 105 randomized to receive T gel (Androgel 1.62%). Following a 13-week efficacy phase, men continued to receive their assigned treatment for up to 52 weeks, returning at weeks 26, 39, and 52 for safety assessments.

The effects of the drugs on lipid parameters, such as cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides, were similar between treatment arms at week 52. Androgenic parameters, including hematocrit and hemoglobin, platelet, and PSA levels, showed no significant changes from baseline to the end of study between the treatments.