Pharmaceutical company Endo is terminating its agreement with Acerus Pharmaceuticals Corporation to market the nasal testosterone treatment NATESTO in the United States, effective June 30, 2016.
NATESTO was approved in May 2014 and is the first and only testosterone nasal spray gel sold in the U.S. for the treatment of hypogonadism, a condition in which men do not produce enough testosterone due to injury or disease. The gel is available as a metered dose pump containing 60 actuations. Each pump delivers 5.5mg of testosterone in 0.122g gel.
“While we are disappointed with Endo’s previously announced strategic business decision to realign their U.S. branded resources from urology retail to their pain franchise, we are fully committed to the continued success of NATESTO in the U.S.,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Our immediate focus is on finding a new NATESTO partner in the U.S., the largest market for testosterone replacement therapy.”
The U.S. leads the world in sales of testosterone replacement therapy due largely to heavy promotion by manufacturers of testosterone treatments. Drug companies coined the phrase “Low T” and told men they could suffer from the condition if they experienced symptoms such as low sex drive, muscle loss, weight gain, and mood swings. While the push was successful for drug companies, resulting in millions of dollars of sales in the U.S. alone, men were left to suffer testosterone side effects, some of which were deadly.
Studies revealed that men who took testosterone replacement treatments had an increased risk of heart attack, stroke or death. The risk appears greater in the first 90 days after men begin treatment.
Makers of testosterone treatments are facing hundreds of lawsuits alleging their failure to warn about heath risks associated with their hormone treatments.