Melbourne-based Acrux (ASX: ACR) has responded to the FDA's decision to require label changes for all prescription testosterone products.
The company's testosterone replacement therapy, AXIRON, which is based on its innovative technology that delivers drugs through the skin, is marketed by Lilly under a global agreement with Acrux. It was originally developed by researchers at Monash University and allows for the continuous delivery of testosterone over the 24-hour dosing interval following application to the underarm.
Acrux confirmed in a statement that Lilly "will continue to work closely" with the FDA.
"Based on the FDA's statement, the agency is requiring labelling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone risk. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy," it said.
According to the FDA's statement, "We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products."
It said that it was "encouraging" manufacturers with testosterone products to work together on a clinical trial.