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 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.
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 the 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, the 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 as “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 and Alcohol: Your Health and the Holiday Season - February 27th, 2021
- Testosterone builds muscle but has risks - February 25th, 2021
- New Study Finds That Testosterone Does Not Increase Cardiovascular Risk - February 22nd, 2021
- Evidence Suggests Testosterone Plays Powerful Role in Motivating Revolutionary Change - February 15th, 2021
- How Testosterone Affects the Skin of Men - February 11th, 2021
- The Effects of Parenthood Upon Testosterone Levels - January 9th, 2021
- Testicular Cancer Survivors are at Risk for Low Testosterone - January 6th, 2021
- Amygdala and it's Relationship to Testosterone and Fear - December 25th, 2020
- Testosterone Does Not Cause Atherosclerosis (Hardening of the Arteries) in Older Men - December 24th, 2020
- Increased Testosterone DOES NOT Cause Prostate Cancer to Spread - December 23rd, 2020
- Testosterone Cypionate and Testosterone Enanthate: The Real Facts - December 20th, 2020
- A Surprising Side Effect of Methadone Treatment: Suppressed Testosterone - December 18th, 2020
- The Testosterone Industry Globally is Booming - December 12th, 2020
- Five Benefits of Testosterone That You Need to Know - December 11th, 2020
- New Research Proves Testosterone Replacement Therapy is Safe for the Heart - December 3rd, 2020
- Skinny Bartender with Low Testosterone Becomes a Ripped Bodybuilder - December 3rd, 2020
- Low-T and Your Health - November 30th, 2020
- Low Testosterone Levels may Affect Man's Sex Drive and Affect his Intimate Relationships - November 19th, 2020
- Is Testosterone the New Drug of Choice on Wall Street? How Traders are Using Male Hormone Booster Shots to Maintain a ... - November 12th, 2020
- Shorter course of ADT for high-risk prostate cancer patients yields improved quality of life - November 11th, 2020
- Testosterone Litigation: What You Need To Know - MTMP - Video - November 9th, 2020
- Methadone Lowers Testosterone in Men Only - November 8th, 2020
- Intricate relationship between Oestrogen & Testosterone XXY Guys (Klinefelters' syndrome) - Video - November 7th, 2020
- Should middle-aged men consider 'low T' treatment? - November 5th, 2020
- Testosterone and Crime: What Can Genes Tell Us About Behavior? - Video - October 25th, 2020
- Testosterone shown to help sexually frustrated women - October 22nd, 2020
- Testosterone levels seen prior to birth in fetus' fingers, jawline - October 20th, 2020
- Tri-Blend Testosterone. Understanding the Benefits of Testosterone Oils - October 19th, 2020
- Testosterone levels in older men - October 17th, 2020
- Tlando Testosterone Clinical Trial for Low-T and Fatty Liver Disease - October 4th, 2020
- Testosterone Focus in Diabetes Study – Video - September 30th, 2020
- Testshock Review All Natural Testosterone Enhancement – Video - September 30th, 2020
- Testosterone, Anxiety, and Depression - September 30th, 2020
- Average Testosterone Levels Decreasing Over Time Among Younger American Men - August 21st, 2020
- Testosterone Creams for Low Testosterone Treatment and Andropause - August 10th, 2020
- Testosterone Therapy and Androgen Deficiency Guide - August 6th, 2020
- Testosterone's Surprising Link to Men's 'Love Hormone' Oxytocin - August 5th, 2020
- Fortesta Brand Testosterone Therapy - August 3rd, 2020
- Andropause: Age-Associated Testosterone Decline - August 1st, 2020
- How to Build Muscle Quickly by Boosting Testosterone Levels - July 29th, 2020
- Testosterone Deficiency Strongly Linked to Heart Attack Risk in New Study - July 26th, 2020
- Seven Types of Drugs That Can Inhibit Sex Drive and Libido - July 22nd, 2020
- Testosterone and Geriatric Frailty - July 21st, 2020
- Testosterone and Aggression: How T-Levels Impact Human Response to External, Social Threats - July 12th, 2020
- High-Dose Testosterone Injections May Be a Viable Palliative Late-Stage Prostate Cancer Treatment - July 12th, 2020
- Could Civilization Have Been Formed as a Result of Declining Testosterone Levels in Males? - July 6th, 2020
- Testosterone Therapy Allows Man to Have the Body That He Was Meant to Have - July 5th, 2020
- Testosterone Injections for Low-T and Andropause - July 4th, 2020
- Testosterone Replacement Therapy (TRT) Reduces the Risk of Serious Adverse Health Consequences! - June 30th, 2020
- More Sex: A Better Way to Boost Your Testosterone Levels - June 29th, 2020
- Testosterone not always to blame - Sat, 04 Aug 2012 PST - June 28th, 2020
- Five Facts About Testosterone (That Maybe You Didn't Know) - June 27th, 2020
- Manhood Washed Away: You Could Unknowingly be Annihilating Your Testosterone - June 23rd, 2020
- Testosterone: Should You Take it to Regain Your Libido and Youthful Energy? - June 22nd, 2020
- Testosterone Replacement Therapy Boosts Aerobic Capacity - June 15th, 2020
- Physiology of Testosterone - June 9th, 2020
- The Truth Behind Common Male Sex Myths - May 26th, 2020
- Dr. Andre Berger on Testosterone Deficiency in Men - Andropause Symptoms and Treatment By Doctor's Desk Series - May 21st, 2020
- How to Raise Testosterone Naturally. Sermorelin - Some Have Called It A The New Fountain of Youth. A Natural Cure for Anxiety and Depression. - May 9th, 2020
- Are Athletes Using Green Tea to Mask Testosterone Doping? - May 7th, 2020
- Some Animal Research Suggests that High Testosterone May Increase Prostate Cancer Risk - May 5th, 2020
- Eleven Foods that Can Drain Your Libido - May 4th, 2020
- Testosterone Can Make Us Generous, But Only When We Do Not Perceive a Threat - May 3rd, 2020
- A New Link Between Testosterone and the Prevention of Dementia in Women - May 3rd, 2020
- Why Women Make Better Money Managers - April 30th, 2020
- Is Being a Lumberjack More Manly Than a Football Player? It's All in the Testosterone! - April 28th, 2020
- Testosterone Drug, Androxal, Helped Gay Cubans Have More Sex - April 10th, 2020
- Androxal Meets its Testosterone Study Goals - April 1st, 2020
- Testosterone Replacement Beneficial for Modern Men? - February 11th, 2020
- Low on Testosterone? No Problem! - February 10th, 2020
- Dr. Richard Bebb - Testosterone, Diabetes and the Metabolic Syndrome - Video - January 21st, 2020
- Baby Boomers find “The Fountain of Youth” in Testosterone - September 2nd, 2019
- Declining Testosterone Levels in Men Not Part of Normal Aging - August 12th, 2019
- TEFINA: Nasal Spray That Can Increase Female Orgasms - August 10th, 2019
- Quick Weight Loss Tips and Diet Recommendations for HRT - August 10th, 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
- 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
Word Count: 1054