Recently, the only methods to deliver testosterone replacement therapy (TRT) were to receive an injection, swallow pills or apply a topical gel.
However, a new approach has emerged that is more convenient for some.
TRT is now available using a nasal gel that raises men’s low testosterone levels to normal, with few side effects.
Video Download: Testosterone Nasal Gel A New Form Of Testosterone Replacement Therapy
Video Stream: Testosterone Nasal Gel A New Form Of Testosterone Replacement Therapy
This exciting development is based on the results of the phase 3 clinical trial to be presented at the Endocrine Society’s 97th annual meeting in San Diego.
Last May, the U.S. Food and Drug Administration (FDA) approved the drug called Natesto, which is the only FDA-approved nasal testosterone replacement therapy, according to the manufacturer, Trimel Pharmaceuticals.
Under the terms of the agreement, Trimel will receive an upfront payment of $25 million and could receive additional payments upon the achievement of certain regulatory and sales milestones.
Under the terms of the agreement, Trimel will be solely responsible for the manufacture and supply of Natesto, and Endo receives exclusive commercial rights to the Natesto product in the US and Mexico.
Also, Endo will collaborate on all regulatory and clinical development activities in coordination with Trimel. And, Endo will pay a tiered supply price for the product. Endo expected the transaction to close in 2015.
"We are pleased to acquire the rights to Natesto to enhance our branded pharmaceutical portfolio further and look forward to leveraging our commercial expertise in the areas of men's health and urology to support this highly differentiated product," said Rajiv De Silva, President, and CEO of Endo.
"Natesto offers a unique intranasal delivery system which will expand options for appropriate patients seeking testosterone replacement therapy, and we are focused on getting Natesto to market as expeditiously as possible."
“The unique delivery system makes this a convenient and easy-to-use, self-administered form of testosterone to treat adult males with hypogonadism [low testosterone],” said the study’s lead investigator and a consultant to Trimel, Alan Rogol, MD, Ph.D., who is a professor emeritus at the University of Virginia, Charlottesville.
“Also important is that intranasal testosterone minimizes the risk of unwanted secondary exposure of testosterone to women or children,” Rogol said.
Testosterone products applied to the skin have a potentially huge problem: this method of delivery risks transferring some of the drugs to others with whom the user comes into close contact with.
In contrast, the new formulation sends testosterone directly into the nostril.
The product arrives in a multiple-dose pump dispenser that administers a specified amount of testosterone gel (5.5 milligrams, or mg) inside each nostril.
The phase 3 clinical trial measured the effectiveness and safety of the nasal testosterone gel in 306 men with low testosterone at 39 outpatient centers in the U.S.
Men used the treatment for 90 days in both nostrils either twice a day (228 men) or three times a day (78 men) as randomly assigned, to determine the most efficient dose.
They then stayed on the drug for another 90 or 180 days to evaluate tolerance to the medication and effects of treatment.
After 90 days of treatment, the average testosterone concentration in the blood was in the usual range for 90 percent of men who used the nasal gel three times daily, compared with 71 percent of men using it twice a day.
(This measure was in the intent-to-treat population: all subjects who received the randomized study drug and had at least one valid post-baseline efficacy measurement.)
As a result of the study, the manufacturer’s recommended dosing is now three times a day in each nostril, for a total daily dose of 33 mg.
Additionally, treatment also strongly improved men’s erectile function and mood, Rogol reported.
So far, no severe side effects related to the medicine occurred in either dosing group, according to the investigators.
Rogol said there were few problems with tolerating the nasal gel, with a mere 3.7 percent of men receiving the three-times-daily dose ceasing use of the medication due to side effects.
Of 99 men who completed a survey on their experience with the drug, 84 percent felt confident they were correctly using the pump applicator within two days of beginning treatment.
“These results indicate that nasal testosterone gel is an effective and practical alternative to other available testosterone replacement therapy products,” Rogol said.
Facts you need to know about Natesto Nasal Gel
Indications and Usage
Natesto is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including:
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
Limitations of Use
Safety and efficacy of Natesto™ in males less than 18 years old have not been established
Natesto for intranasal use is available as a metered-dose pump.
One pump actuation delivers 5.5 mg of testosterone.
The recommended dose of Natesto™ is 11 mg of testosterone (two pump actuators, one per nostril), applied intranasally three times daily for a total daily dose of 33 mg.
- Men with carcinoma of the breast or known or suspected prostate cancer must exercise extreme caution, and work in close collaboration with their physician to monitor any adverse developments. Specifically, this includes monitoring serum testosterone, prostate-specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically
- Pregnant or breastfeeding women should not use Natesto, since testosterone may cause fetal harm
Warnings and Precautions
- Nasal adverse reactions: nasal signs and symptoms should be monitored. Natesto is not recommended for use in patients with chronic nasal conditions or alterations in nasal anatomy
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH
- Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE
- Women and children should not use Natesto
- Exogenous administration of androgens may lead to azoospermia, which is defined “the medical condition of a man not having any measurable level of sperm in his semen.”
- Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal (kidney), or hepatic (liver) disease
- Sleep apnea may occur in those with risk factors
- The most common adverse reactions (incidence >/=3%) to Natesto observed in clinical trials were an increase in prostate-specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis, and nasal scab.
- Testosterone levels seen prior to birth in fetus' fingers, jawline - September 16th, 2019
- New Study Finds That Testosterone Does Not Increase Cardiovascular Risk - September 2nd, 2019
- Baby Boomers find “The Fountain of Youth” in Testosterone - September 2nd, 2019
- Dr. Richard Bebb - Testosterone, Diabetes and the Metabolic Syndrome - Video - August 21st, 2019
- Declining Testosterone Levels in Men Not Part of Normal Aging - August 12th, 2019
- Low Testosterone Levels may Affect Man's Sex Drive and Affect his Intimate Relationships - August 11th, 2019
- TEFINA: Nasal Spray That Can Increase Female Orgasms - Video - August 10th, 2019
- Quick Weight Loss Tips and Diet Recommendations for HRT - August 10th, 2019
- Testosterone and Alcohol: Your Health and the Holiday Season - August 9th, 2019
- Testosterone builds muscle but has risks - August 4th, 2019
- Testosterone not always to blame - Sat, 04 Aug 2012 PST - August 4th, 2019
- Testosterone, the Power Hormone - August 1st, 2019
- Behavior and Lifestyle Linked to the Effect of Declining Testosterone, Not Necessarily Natural Aging - July 31st, 2019
- BUSTED: Myths About Testosterone And Its Link To Sexual Desire In Men And Women - July 28th, 2019
- Testosterone shown to help sexually frustrated women - July 20th, 2019
- Green tea could mask testosterone doping - July 14th, 2019
- Some experts say testosterone decline is a normal part of aging in men - July 14th, 2019
- The Secret to Guys’ Sex Appeal: Low Stress, High Testosterone, Strong Immunity - July 7th, 2019
- Low on testosterone? No problem - July 7th, 2019
- Is testosterone the new drug of choice on Wall Street? How traders are using male hormone booster shots to maintain a ... - July 4th, 2019
- The Effects of Parenthood Upon Testosterone Levels - April 22nd, 2019
- Testicular Cancer Survivors are at Risk for Low Testosterone - April 21st, 2019
- Amygdala and it's Relationship to Testosterone and Fear - April 19th, 2019
- Testosterone Does Not Cause Atherosclerosis (Hardening of the Arteries) in Older Men - April 19th, 2019
- Increased Testosterone DOES NOT Cause Prostate Cancer to Spread - April 19th, 2019
- Testosterone Cypionate and Testosterone Enanthate: The Real Facts - April 19th, 2019
- A Surprising Side Effect of Methadone Treatment: Suppressed Testosterone - April 19th, 2019
- Low T - My life was falling apart because I had low testosterone - April 16th, 2019
- Testosterone Replacement Beneficial for Modern Men? - April 2nd, 2019
- What Is Testosterone AndroGel - April 2nd, 2019
- How long does it take for Testosterone replacement treatments and therapy to work? - April 2nd, 2019
- The Testosterone Industry Globally is Booming - April 1st, 2019
- Five Benefits of Testosterone That You Need to Know - March 31st, 2019
- Testosterone: Should You Take it to Regain Your Libido and Youthful Energy? - March 17th, 2019
- Manhood Washed Away: You Could Unknowingly be Annihilating Your Testosterone - March 17th, 2019
- New Research Proves Testosterone Replacement Therapy is Safe for the Heart - March 17th, 2019
- Skinny Bartender with Low Testosterone Becomes a Ripped Bodybuilder - March 16th, 2019
- Five Facts About Testosterone (That Maybe You Didn't Know) - March 16th, 2019
- Testosterone's Surprising Link to Men's 'Love Hormone' Oxytocin - March 16th, 2019
- More Sex: A Better Way to Boost Your Testosterone Levels - March 15th, 2019
- Testosterone Replacement Therapy Boosts Aerobic Capacity - March 15th, 2019
- Testosterone Replacement Therapy (TRT) Reduces the Risk of Serious Adverse Health Consequences! - March 15th, 2019
- Eleven Foods that Can Drain Your Libido - September 6th, 2018
- Some Animal Research Suggests that High Testosterone May Increase Prostate Cancer Risk - September 6th, 2018
- The Truth Behind Common Male Sex Myths - August 27th, 2018
- Physiology of Testosterone - August 26th, 2018
- Testosterone Injections for Low-T and Andropause - August 26th, 2018
- Testosterone Therapy Allows Man to Have the Body That He Was Meant to Have - August 26th, 2018
- Could Civilization Have Been Formed as a Result of Declining Testosterone Levels in Males? - August 26th, 2018
- Testosterone and Aggression: How T-Levels Impact Human Response to External, Social Threats - August 21st, 2018
- Testosterone Deficiency Strongly Linked to Heart Attack Risk in New Study - August 19th, 2018
- Testosterone and Geriatric Frailty - August 18th, 2018
- Seven Types of Drugs That Can Inhibit Sex Drive and Libido - August 18th, 2018
- Low-T and Your Health - August 17th, 2018
- How to Build Muscle Quickly by Boosting Testosterone Levels - August 9th, 2018
- Andropause: Age-Associated Testosterone Decline - August 5th, 2018
- High-Dose Testosterone Injections May Be a Viable Palliative Late-Stage Prostate Cancer Treatment - August 5th, 2018
- Fortesta Brand Testosterone Therapy - August 3rd, 2018
- Testosterone Therapy and Androgen Deficiency Guide - August 2nd, 2018
- Testosterone Creams for Low Testosterone Treatment and Andropause - August 1st, 2018
- Testosterone, Anxiety, and Depression - July 9th, 2018
- What is Testosterone? What does Testosterone do? Find on - August 9th, 2016
- The Truth About Testosterone | The Dr. Oz Show - June 9th, 2016
- How Men Work | HowStuffWorks - May 28th, 2016
- 6 Ways to Increase Testosterone Levels Naturally - wikiHow - May 4th, 2016
- Testosterone: Common Questions | Testosterone Test: Total ... - May 4th, 2016
- Adrenalast Testosterone Booster | Boost Muscle Sexual ... - April 6th, 2016
- How to Lower Testosterone in Women | eHow - February 8th, 2016
- Testosterone Booster Reviews - Consumers Guides - February 8th, 2016
- A Harvard expert shares his thoughts on testosterone ... - February 8th, 2016
- Does Andro 400 Work; does it increase testosterone? - February 8th, 2016
- All About Testosterone! - Bodybuilding.com - February 8th, 2016
- 5 Natural Testosterone Boosters - Healthline - November 2nd, 2015
- Testosterone - Low-T and Androgen Replacement Therapy - November 2nd, 2015
- Effect of vitamin D supplementation on testosterone levels ... - October 17th, 2015
- Testosterone nasal gel works best at three doses a day, study finds - October 4th, 2015
- Testosterone: The Test | Testosterone Test: Total ... - October 1st, 2015
- Testosterone: A Major Breakthrough for Menopausal Women - October 1st, 2015
- Testosterone (film) - Wikipedia, the free encyclopedia - October 1st, 2015
- Low Testosterone Treatment, Low T - AXIRON (testosterone ... - September 16th, 2015
Contact Us Now
How useful was this post?
Click on a smiley face to rate it!
Average rating / 5. Vote count:
Word Count: 1057