- A small Illinois drugmaker has once again placed its investigational hormone therapy at the Food and Drug Administration's doorstep, hoping new data — and a name change — will give the treatment a better shot at advancing to market.
- Clarus Therapeutics, the private, clinical-stage biotech, on Monday resubmitted its New Drug Application (NDA) for Jatenzo (testosterone undecanoate), an oral medicine aimed at boosting testosterone levels in men who have deficiencies, which usually arise from genetic conditions or chemotherapy treatment. The fresh filing comes on the heels of the Phase 3 inTUne trial that showed 87% of men taking the drug developed normal amounts of testosterone.
- Jatenzo was initially submitted back in early 2014 under the name Rextoro. But following an starkly negative opinion about the drug's risk-benefit profile from an FDA advisory panel in September of that year, the agency rejected it a couple months later. The panel also voted 12-8 against the drug's efficacy.
Getting medicines for diminished testosterone levels, often referred to as "low-T," to pharmacy shelves has become increasingly difficult in recent years.
The FDA, for one, has cracked down on the labeling for testosterone products, pushing for greater transparency about their potential cardiovascular risks. Recently published research also underscores the prominent role direct-to-consumer ads played in upping testosterone replacement prescriptions and off-label use. Now, drugmakers such as AbbVie are facing thousands of lawsuits over the adverse side effects of their hormone therapies and the lack of warnings presented in their marketing campaigns.
In spite of that pushback, drugmakers are still ushering their candidates forward, if for no other reason than the potential payoffs. Market intelligence firm Technavio last year projected the global testosterone replacement therapy market would hit $2 billion by 2020, while Global Industry Analysts predicted in April that the market would hit $3.4 billion by 2022, aided by a rise in hypogonadism stemming from aging male populations.
With money on the line, several pharmas and biotechs are hoping to get their potential products to market. Salt Lake City-based Lipocine filed its own oral testosterone replacement medication, LPCN 1021, for approval in 2015, though it too received a complete response letter. The rejection pertained to the drug's dosing regimen, so the company has enacted a dosing validation and flexibility study to right the issues.
Given that most testosterone replacement products come in either topical or injectable forms, offering an oral medication — considered by many in the healthcare continuum to be an easier, more adherence-friendly option for patients — could be a big win for either company.
"An oral T-replacement product would not only be convenient, but would avoid many of the safety issues associated with accidental transfer of T to women or children that can occur from transdermal T products," Clarus' Chief Medical Officer Theodore Danoff said in a June 26 statement. "Moreover, published data indicates that men on transdermal T products often do not adhere to their treatment plan and we believe an oral option may improve this."