The FDA has cautioned about the use of testosterone products for low testosterone due to aging. The agency is also concerned about safety issues. There is certainly a risk associated with existing testosterone products, which include topical gels, patches and invasives. However, many of the problems associated with existing products do not exist with LPCN 1021, which is an oral TRT.
Given that many of the problems associated with existing products do not exist with oral TRT, it is likely that the FDA might give a nod to LPCN 1021 despite it being cautious about testosterone replacement therapies. And given that an oral therapy is more convenient than topical gels and invasives, LPCN 1021 has the potential, if approved, to capture a significant portion of the $2.3 billion testosterone replacement market.
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