Just days after Endo International agreed to pay $400 million to settle thousands of lawsuits alleging its transvaginal mesh device was defective and caused women injuries, the company announced it has entered an agreement to acquire the rights to Natesto, a testosterone replacement treatment in the form of a nasal gel, from Trimel BioPharma SRL. The transaction is expected to be completed by early 2015.
Endo is one of several manufacturers of transvaginal mesh facing litigation. The devices are used to treat pelvic organ prolapse and stress urinary incontinence. They have been associated with serious injuries including erosion, organ protrusion, infections, bleeding and chronic pain.
Natesto was approved by the Food and Drug Administration (FDA) in May for the treatment of hypogonadism, a condition in which a man’s body does not produce enough testosterone, resulting in symptoms such as low sex drive and muscle loss.
The FDA’s approval came at a controversial time for testosterone treatments. Drug makers have fallen under scrutiny for aggressive marketing campaigns targeting men with advertisements claiming testosterone therapy can reverse other symptoms of aging including weight gain and fatigue. Prescriptions of the drugs skyrocketed in recent years. But studies have begun to shed a different light on the drugs with reports of heart attacks, strokes and death in men who have used the products.
The studies prompted the FDA to launch an investigation into the treatments, which resulted in a new warning for blood clots in the veins. An advisory panel also recommended that the indication for testosterone replacement therapy be revised so that it is limited to patients who are proven to have hypogonadism through testing. The committee also voted to recommend that cardiovascular safety studies be performed to identify cardiovascular risk.
As a result, prescriptions for testosterone drugs are declining.
Manufacturers of testosterone treatments face mounting lawsuits alleging they knew of the cardiovascular risks with the drugs but failed to adequately warn the public. It is not known whether Endo will inherit any lawsuits naming Natesto. The company still faces about 5,000 lawsuits over its allegedly defective transvaginal mesh.