It's a bad day for Big Pharma when it comes to new testosterone formulations. Two new drugs, Tlando and Jatenzo did not gain approval by an FDA advisory panel. Both are oral forms of testosterone undecanoate, meant to be taken daily. The two new drugs were turned down over fears of side effects on cardiovascular health and cholesterol levels. The financial press has the news:
Lipocine arrived at the FDA meeting armed with data from two phase 3 trials showing Tlando moves average serum testosterone concentrations up into the normal range in most people. That result was enough for the studies to meet their primary endpoints. But the overall dataset failed to quell fears about cardiovascular adverse events and the drug’s effect on blood pressure.
Lipocine arrived at the FDA meeting armed with data from two phase 3 trials showing Tlando moves average serum testosterone concentrations up into the normal range in most people. That result was enough for the studies to meet their primary endpoints. But the overall dataset failed to quell fears about cardiovascular adverse events and the drug’s effect on blood pressure.
