Lipocone’s testosterone replacement therapy, Tlando, has been rejected by the U.S. Food and Drug Administration again.
Sometimes men who suffer from erectile dysfunction are given testosterone in hopes that it will serve as a cure to what ails them.
But the erectile dysfunction drug Viagra has been found to work for more than 80% of men and many doctors agree that it’s the best first-choice treatment for erectile dysfunction.
Testosterone for erectile dysfunction
Many of the testosterone treatments to date have been marketed to men with erectile dysfunction and lack of sex drive, but the FDA continues to issue warnings about what testosterone treatments should and shouldn’t be used for.
In March 2015, the FDA wrote, “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”
Concerns over Tlando
This brings us back to Tlando, which the FDA has concerns about regarding dosing and data validity. Specifically, the FDA wants Lipocine to:
• Do a study to show that there is “definitive evidence” that Tlando offers a clinically meaningful increase in blood pressure for me with low testosterone
• Confirm the reliability of testosterone and maximum serum concentration (Cmax) data related to Tlando
• Explain why the Cmax secondary endpoints for Tlando don’t apply here
• Create criteria to identify men who should stop taking Tlando
Viagra for erectile dysfunction
For men with erectile dysfunction, testosterone treatments aren’t usually the first course of action. Instead, most doctors consider prescribing an FDA-approved erectile dysfunction drug, such as Viagra.
Viagra is the most popular erectile dysfunction drug in the world, as well as the most counterfeited, which is why a prescription is required. This helps ensure men are getting real Viagra, and that’s it’s effective and not tainted with toxic ingredients.
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