FDA moves aggressively on low-T drugs, but replacement pill still aims to enter market

Last week the FDA cracked down hard on low-T therapies. Its expert panel voted to advise the agency to restrict the use of such drugs for a specific medical need. And a majority wanted cardiovascular studies to assess age-related risks. Then the agency voted to reject Clarus Therapeutics' Rextoro, which was aiming to become the first oral therapy in a market dominated by gels. This week Lipocine is talking up the Phase III results of its testosterone replacement pill, but the timing is downright horrible, given the agency's turn against the market generally. Story | More