Call Us: 1.800.873.5297

By

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.

If you suffered injuries after using testosterone therapy, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

 

The choice of a lawyer is an important decision and should not be based solely on advertisements.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.