Testosterone replacement therapy (TRT) is indicated for the treatment of androgen deficiency in hypogonadal men. The US Food and Drug Administration (FDA) has approved several testosterone formulations for the treatment of hypogonadism in men, including injectable testosterone esters, transdermal testosterone patch, transdermal testosterone gels and solution, buccal adhesive testosterone tablets, intranasal testosterone, and testosterone pellets. However, each of these modes of testosterone delivery, has significant drawbacks.
A feature common to the currently available delivery methods is the high variability in bioavailable testosterone as patients vary between super- and sub-therapeutic levels. This results in undesirable side effects and high rates of treatment discontinuation. These side effects include large fluctuations in mood and sexual function. In addition, treatment-specific side effects are noted, such as inadvertent contact transfer associated with testosterone gel formulations; women and children are particuarly susceptible to the significant side effects cross-contamination.
Thus, there is an unmet clinical need for improved formulations for testosterone replacement therapy (TRT). The limitations of the currently available testosterone formulations have stimulated tremendous interest in developing long-acting delivery systems that can provide uniform circulating levels of testosterone in the target therapeutic range.
To address the shortcomings of currently available testosterone formulations, the FPT team is in development of a nanoTconsign (nTc) nanoparticle formulation for sustained, consistent release. This novel next-generation formulation offers the promise of superior pharmacokinetics, uniform delivery of testosterone sustained for up to four weeks, improved adherence, and treatment outcomes for patients seeking testosterone replacement therapy.
The nTc is a novel proprietary nanoparticle formulation that utilizes FDA approved biocompatible polymeric materials such as poly (lactic-co-glycolic acid), poly (lactic acid), poly (glycolic acid), poly-l- (glutamic acid), and amphiphilic components. This aqueous formulation eliminates the oil depot related adverse effects, and as shown in preliminary results, delivers testosterone uniformly without the burst release. The formulation has been developed using the components and knowhow of NanoMed technology licensed exclusively by FPT, LLC for the nTc testosterone formulation and is protected by patents (US9545382 B2, PCT/IN2013/000141) for hormone delivery.