TLANDO, Oral Testosterone Replacement Therapy without Dose Titration Requirement Introduction: Most marketed testosterone replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugo

TLANDO, Oral Testosterone Replacement

Therapy without Dose Titration Requirement

Introduction: Most marketed testosterone

replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugonadal testosterone (T) levels.

For the majority of patients, typical titration of TRT takes 3-6 months with multiple blood draws and titrations (mostly up titrations)

to reach an efficacious dose (e.g., ANDROGEL 1.62 and JATENZO ). The additional dose adjustment visits are burdensome

for patients and physicians. Moreover, a major reason for discontinuation is possibly related to inadequate therapeutic response

within 3-6 months of therapy. Selection of an efficacious dose from the start of therapy with no potential for titration decision

errors remains an unmet need. TLANDOTM (LPCN 1021, testosterone undecanoate) is an easy to use oral TRT option

designed to enable effective T replacement in hypogonadal males from the start of therapy without dose titration requirement. The

oral, fixed-dose regimen of TLANDOTM may offer additional advantages over most existing TRT options, including

absence of accidental transfer risk, absence of application site reactions or need for self-injections, consistent inter-day performance,

no additional clinic/pharmacy visits, favorable liver safety profile, and low hematocrit (HCT) increase. TLANDOTM

may essentially improve patient adherence and persistence to TRT.

Objective: The objective was to

assess whether TLANDOTM, an oral fixed-dose regimen TRT option, can safely and effectively restore testosterone

levels in hypogonadal men without need for any dose adjustment.

Methods: A 24 day, open-label, single-arm,

multicenter study with TLANDOTM in hypogonadal men (NCT03242590) was conducted. Subjects (N=95) received 225

mg testosterone undecanoate orally twice a day. At the end of study, blood samples were collected over a 24-hour period for pharmacokinetic

analysis. The primary endpoint was the percentage of TLANDO-treated subjects who achieved a 24-hour average serum T concentration

(T Cavg) within the eugonadal range of 300 to 1080 ng/dL after 24 days of treatment. Key safety endpoints included incidence of

adverse events (AEs), physical examination results, clinical laboratory test results, and changes in HCT and prostate-specific

Results: 94 subjects completed the

study with mean age of 56.0 years, mean BMI of 32.8 kg/m2, and baseline T level 202 75 ng/dL. The vast majority, 81% (95%

CI 72% - 88%), of hypogonadal subjects achieved T Cavg within the normal range post ~3 weeks of treatment without requiring dose

adjustment. T Cavg and the mean peak serum T concentration were 476 174 ng/dL and 1178 484 ng/dL, respectively.

The incidence of treatment emergent adverse events (TEAEs) was 21%. Decrease in lipids was observed (-8.9 mg/dL for triglycerides,

and -10.6 mg/dL for total cholesterol). The most frequent TEAEs were blood prolactin increase (6.3%), weight increase (2.1%), headache

(2.1%), and musculoskeletal pain (2.1%). Increase in hematocrit (0.9% CBL) and PSA (0.2 g/L CBL) were observed.

Conclusions: Safety and efficacy

of TLANDOTM, a clinically easy to use oral TRT without dose titration requirement, was confirmed. TLANDOTM

is well suited to improve persistence rates in TRT therapy.

Authors: Anthony DelConte*, Nachiappan Chidambaram, Kongnara

Papangkorn, Benjamin J. Bruno, Kilyoung Kim, Mahesh V. Patel