Penn Researchers Start Trial of Pheromone-Based Treatment

(Philadelphia, PA) - Sometimes, a good deep, cleansing breath can really do a world of good to change your mood. Now researchers at the University of Pennsylvania School of Medicine are testing a nasal spray medication designed to do just that for sufferers of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD), a severe form of PMS featuring significant depression and other mood problems. Ellen Freeman, PhD, of the Penn department of Obstetrics and Gynecology, is seeking women to participate in the Phase-II clinical trial of the medication, called PH80.

PH80 uses molecules that, like certain pheromones, can influence physiology and behavior when breathed in through the nose. While researchers are only beginning to understand the workings of pheromones in humans, this is one of the first pharmaceuticals developed to use the pheromone method of drug delivery.

"This is a decidedly unique approach to treating the symptoms of PMS and PMDD," said Freeman, research professor and co-director of Penn's Center for Human Behavior and Reproduction. "The nasal spray is designed to provide near-instant relief on-demand, and this trial will determine whether it is a promising treatment for clinically significant PMS."

PH80 uses pheromone-like molecules to stimulate nerve receptors in the vomeronasal organ (VMO), which is located just inside the nasal passages. When stimulated, the receptors send a signal to the hypothalmus, a region of the brain that regulates the endocrine and central nervous system. The medication is produced by Pherin Pharmaceuticals, a corporation that specializes in the production of pheromone-based pharmaceuticals.

"One of the possible benefits of a drug like PH80 is that it may produce quick relief in small dosages," said Freeman, "which means that women suffering from PMS and PMDD can treat the symptoms as they occur."

Currently, the only FDA-approved treatment for the symptoms of PMS and PMDD are SSRIs - or Selective Serotonin ReUptake Inhibitors - medications that were initially designed for the treatment of depression. Unlike SSRIs, women using PH80 do not need to take the drug on a regular basis, but can use it as they feel symptoms, such as mood swings and irritability, develop. This Phase-II study is part of the ongoing research into PH80, examining the efficacy of the drug in treating the symptoms of PMS and PMDD.

To participate in this study, women must be between 21 and 37 years old and have regular menstrual cycles. Qualified volunteers will receive free medications, lab tests, office visits, valet parking, and travel reimbursement. Daytime appointments are available Monday through Friday at the Hospital of the University of Pennsylvania office. Evening appointments are available on several weekdays. Appointments are also available at offices in Radnor and Chestnut Hill, Pennsylvania and in Marlton and Egg Harbor Township, New Jersey.

For more information, please contact the Premenstrual Syndrome Program at Penn at 1-800-662-4487 or 215-662-3329.

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Editor's Note: Dr. Freeman has no financial interest in Pherin Pharmaceuticals, Inc.

The University of Pennsylvania Health System is distinguished not only by its historical significance - first hospital (1751), first medical school (1765), first university teaching hospital (1874), first fully integrated academic health system (1993) - but by its position as a major player on the world stage of medicine in the 21st century. Penn ranks second among all American medical schools that receive funds from the National Institutes of Health, perhaps the single most important barometer of research strength.

Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 20 years, according to U.S. News & World Report’s survey of research-oriented medical schools. The School is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $405 million awarded in the 2017 fiscal year.

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Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2017, Penn Medicine provided $500 million to benefit our community.

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