New Testosterone Nasal Spray Receives U.S. Patent

The University of Texas at Austin's College of Liberal Arts received their second patent ever from psychology professor Bob Josephs' testosterone nasal spray. This testosterone-containing nasal spray has been designed to help men and women who suffer from depression, anxiety, and sexual dysfunction.

This nasal spray was developed and tested by Professor Robert A Josephs and his graduate students in his Clinical Neuroendocrinology Laboratory over the last seven years. They've taken a look at testosterone's effect on human characteristics such as unethical behavior, leadership, cheating, and anxiety.

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The studies required a fast, safe, and reliable way to administer testosterone to test subjects — a way that did not exist yet. When their first studies started in 2012, it became obvious they were on the hunt for a way to safely and quickly administer testosterone.

Their first studies contained a topical cream and were lead by a Ph.D. candidate Scott Liening, which led to widespread contamination of his lab samples.

As new experiments are conducted by Ph.D. candidate Ellie Shuo Jin are proving the effectiveness of the spray and how it can reduce the anxiety that is evoked by public speaking and test-taking.

Testosterone Nasal Spray Alternative

Patients who suffer from a testosterone deficiency or other ailments such as anxiety may benefit from the fast-acting results. Currently, those who are diagnosed with low testosterone — testosterone deficiency or hypogonadism — could receive hormone supplements via transdermal creams, drops, gels, injections, and subcutaneous "seeds" which could take days or multiple doses to reach full potential.

This new aqueous-based nasal spray initially was developed to address the current market need for comfortable and controlled doses of testosterone for people who suffer from decreased libido or anxiety disorders. Since 2011, prescriptions for testosterone have increased fivefold.

While testosterone therapy has been most often marketed and prescribed to men, UT Austin psychology professor Robert Josephs and MedCara Pharmaceuticals pharmacist Craig Herman developed this nasal spray in response to a long-standing research question about why women are twice as likely to develop anxiety disorders when compared to men.

Some research has shown that while there isn't a difference in anxiety disorders among prepubescents, puberty introduces a sharp uptick in anxiety disorders in girls — who have naturally about one-tenth of the amount of testosterone that boys have. The researchers have speculated that the higher concentration of testosterone in men could protect them against anxiety. Since then, they've begun to develop a treatment to address this issue.

“A growing body of research points to testosterone’s importance in the etiology of anxiety disorders. These findings highlight the potential benefit of rapid increases in testosterone concentration as a means to short-circuit the mechanisms underlying the development of anxiety-related disorders, including panic disorder, social anxiety, and PTSD,” said Josephs, who is also an adjunct professor of psychiatry at the Dell Medical School.

Josephs mentions that testosterone isn't currently prescribed for anxiety, but he hopes that treating these anxiety disorders with short-term fast-acting testosterone product could be prescribed alongside a lower dosage of benzodiazepines — such as Klonopin or Xanax. “Although benzodiazepines work well, they have strong sedative effects,” Josephs said. “Testosterone is not sedating.”

The nasal spray (United States Patent No. 10,258,63, issued on April 16, 2019) has been licensed to Acerus Pharmaceuticals Corporation.

Testosterone and Anxiety

Anxiety and our hormones are related in some ways. Did you know that your hormones may dictate how anxious you feel? When your hormone levels are too low or too high, this influences neurotransmitters and can result in problems such as increased anxiety. Individuals who live with social anxiety disorder may find that levels of certain hormones can relate to feelings of increased or decreased social anxiety.

Researchers suggest that having low testosterone levels could increase anxiety. This is why anxiety often will peak during times of hormonal change such as puberty, certain times of the menstrual cycle in women, and even during menopause in women.

Stress and your sex hormones also have an effect on your anxiety, too. For example, when we are stressed, our cortisol increases. This slows our body's ability to make testosterone. This is a recipe for increased anxiety. What's worse, testosterone also plays some role in the release of cortisol. This means when our testosterone is lower, our cortisol is likely to increase.

It's a cycle that feeds itself and the nasal spray could be the answer to helping us overcome our symptoms. Administration of testosterone has been linked to reducing social anxiety and reduces the socially fearful, avoidant, and submissive behavior. Testosterone boosts the action of gamma-aminobutyric acid and serotonin. These two chemicals are related to social anxiety disorder.

Testosterone has also been shown to reduce the activity of your amygdala, which is the brain structure that is related to fear and initiates your fight-or-flight reaction. An increased amount of testosterone means your amygdala will respond more like a person without an anxiety disorder.