SOMERSET, N.J., Jan. 29, 2018 – The Post-Finasteride Syndrome Foundation today announced Phase II of the clinical research on post-finasteride syndrome (PFS) being conducted at the University of Milano.
Led by Roberto Cosimo Melcangi, Ph.D., head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences, the new study will evaluate:
—In PFS patients: possible epigenetic changes in the 5-alpha reductase enzyme.
—In an animal model of PFS: behavioral parameters, and alterations in neurogenesis, neuroinflammation and neurotransmitter pathways involved in the control of sexual function, as well as possible epigenetic changes in 5alpha-reductase. Possible changes of the gut microbiota composition will also be considered.
This research will build on the Neuroendocrinology Unit’s Phase I study, titled Neuroactive steroid levels and psychiatric and andrological features in post-finasteride patients, which was published in the July 2017 issue of The Journal of Steroid Biochemistry and Molecular Biology.
According to that research, PFS patients suffer from altered levels of critical brain-function regulators, including neuroactive steroids, and those with severe erectile dysfunction suffer from neuropathy of the pudendal nerve.
“Thanks to Professor Melcangi and his team, a clearer picture of what PFS looks like at the molecular level is slowly but surely emerging,” said Dr. John Santmann, CEO of the Post-Finasteride Syndrome Foundation, which funded the research.
Post-finasteride syndrome occurs in men who’ve taken finasteride to treat hair loss, or enlarged prostates. Reported symptoms include: loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, insomnia, severely dry skin and tinnitus. The condition often has a life-altering impact on patients and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicide.
The PFS Foundation has also funded clinical research and statistical analyses at other leading institutions, including:
—Brigham and Women’s Hospital (Boston): Characteristics of Men Who Report Persistent Sexual Symptoms after Finasteride Use for Hair Loss, The Journal of Clinical Endocrinology & Metabolism, September 2016
—Northwestern University Feinberg School of Medicine (Chicago): Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors finasteride or dutasteride, PeerJ, March 2017
—Baylor College of Medicine (Houston): Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients
As of January 2018, the World Health Organization Programme for International Drug Monitoring’s database of adverse drug reactions contained 13,900 finasteride ADRs, including 2,477 reports of erectile dysfunction, and 2,956 psychiatric disorders, including 32 suicide attempts and 55 completed suicides.
In May 2017, the UK’s Medicines and Healthcare Products Regulatory Agency issued a drug-safety update titled Finasteride: rare reports of depression and suicidal thoughts. “Depression and suicidal thoughts,” it read, “have been reported in men with and without a previous history of depression.”
Three months later, the European Medicines Association issued a Periodic Safety Update, in which it noted, “Cumulatively 51 cases of suicidal ideation have been received... Taking into account the serious reported cases…[we] recommended to include a warning…to inform that mood alterations, depression and suicidal ideation have been reported with finasteride." In all, there are 31 EMA member states that could potentially issue such warnings, seven of which have done so to date: Belgium, Denmark, France, Germany, Netherlands, Poland and the United Kingdom.
In March 2015, the U.S. National Institutes of Health listed PFS on its Genetic and Rare Diseases Information Center, noting that “some patients who have taken finasteride have referred to side effects such as sexual dysfunction and depression (sometimes severe)… Studies sponsored by the NIH and other organizations are underway to better understand the effects of 5-alpha reductase inhibitor drugs.”
About Roberto Melcangi
Prof. Melcangi received his Ph.D. degree in Chemistry and Pharmaceutical Technology from the University of Milano in 1982. He is currently Professor of Endocrinology and Head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences in the University of Milano, Italy, and serves on the editorial board of Frontiers in Aging Neuroscience. With 186 peer-reviewed publications (H-index = 46), he is a leading authority in the field of neuroendocrinology and neuroactive steroids, and is organizer of the International Meeting on Steroids and the Nervous System, held biannually in Turin, Italy.
About the PFS Foundation
Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS. In July 2015, the PFS Foundation established The Southwest Brain Bank in the Department of Psychiatry at the University of Texas Health Science Center, whose mission is to collect and study post-mortem human brain and spinal cord tissue in patients with PFS in order to better understand the pathology and etiology of the condition.
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Post-Finasteride Syndrome Foundation