FDA Approves First-Ever Nasal Testosterone Treatment, Natesto™
Trimel Pharmaceuticals Corporation recently announced that the U.S. Food and Drug Administration (FDA) approved the first and only low testosterone nasal gel, Natesto™. The self-administered product has been approved for adult males as a replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone.
Tom Rossi, Trimel Pharmaceuticals Corporation President and CEO, touts that “men suffering from ‘Low T’” will now have a different option to raise their testosterone levels. Some physicians applaud the convenience of Natesto™ in that application of the therapy is directly to the skin lining inside the nostril. Dr. Jeffrey Rosen, a family physician and medical director and founder of clinical Research of South Florida, Miami, said “Natesto™ will offer an alternative delivery system [of testosterone] that is safer and more convenient than other currently available options on the market.”
According to a recent study, Natesto™ was tested in a 90-day Phase III clinical trial that consisted of 306 hypogonadal men, ranging from 28-80 years of age. During the trial period, 78 subjects were treated with 33 mg of testosterone daily. Of these patients, 73 men were included in the evaluation for the drug’s effectiveness on day 90. The study reports that 90% of these patients had testosterone levels within the normal range and only 10% of subjects had testosterone levels below the normal range. However, some physicians are still skeptical, including Dr. Bradley D. Anawalt, Chief of Medicine at the University of Washington Medical Center – Seattle and Chair of the Hormone Health Network for the Endocrine Society, who points out that there are few published data on this type of testosterone therapy.
Other testosterone therapies have been linked to increased risk of blood clots, heart attacks, and stroke. In fact, the FDA announced the launch of an investigation of the cardiovascular risks associated with testosterone therapy. New research suggests that certain men may face an increase risk of serious and potentially life-threatening injuries from testosterone drug side effects. According to a November 2013 study published in JAMA that followed 87,000 men, researchers found that men with low testosterone levels who underwent a coronary angiography suffered a 29% higher rate of heart attack, stroke and death if prescribed testosterone therapy. A study released on January 1, 2014 by the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism raises even further concerns, suggesting that many men prescribed testosterone therapy have normal testosterone levels and do not meet treatment guidelines, especially in the United States.
The Pharmaceutical Litigation Department at Schlichter, Bogard & Denton, LLP represent clients nationwide who have suffered serious and fatal injuries as a result of dangerous pharmaceutical medications. At Schlichter, Bogard & Denton, LLP, we are committed to protecting the rights of persons injured by pharmaceutical companies. The attorneys at Schlichter, Bogard & Denton, LLP are offering a free case review with no further obligation to those who have suffered injuries after using testosterone therapy.
The choice of a lawyer is an important decision and should not be based solely on advertisements.