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Aiming to improve outcomes using neurocircuitry

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Publications

Fasedienol | Itruvone | Refisolone| AV-101

Fasedienol

Fasedienol (PH94B) Publications

Salmán, E., et al (2025). Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal Spray. 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Conference

September 26, 2025

Baker, R., et al (2025). Social Anxiety Disorder among Young Adults (18 – 22 years): A Cross-Sectional Study Using Data from the US National Health and Wellness Survey. ADAA Annual Conference

April 7, 2025

Salmán, E., et al (2025). Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal Spray. 2025 ADAA Annual Conference

April 7, 2025

Anderson, T and Hong, C (2024). Pherines in Psychiatry: A Potential New Paradigm for the Treatment of Mental Disorders. The American Journal of Psychiatry Residents’ Journal | December 2024

December 6, 2024

Baker, R. et al. (2024). Prevalence Trends and Demographic Profiles of Social Anxiety Disorder. 2024 Neuroscience Education Institute (NEI) Congress.

November 11, 2024

Liebowitz, M. et. al. (2024). Fasedienol (PH94B) Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD): Results from the Phase 3 PALISADE-2 Trial. American Society of Clinical Psychopharmacology (ASCP) 2024 Annual Meeting.

May 29, 2024

Liebowitz, M. et. al. (2024). Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Acute Treatment of Social Anxiety Disorder. Anxiety and Depression Association of America (ADAA) 2024 Conference.

April 13, 2024

Monti, L., et. al. (2024). Effect of fasedienol (PH94B) pherine nasal spray and steroidal hormones on electrogram responses and autonomic nervous system activity in healthy adult volunteers. Human Psychopharmacology: Clinical and Experimental, e2892. http

February 5, 2024

Liebowitz, M., Salmán, E., et. al. (2023). Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder. Neuroscience Education Institute (NEI) Annual Meeting

November 10, 2023

Lappalainen, J., Salmán, E., et. al. (2023). A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults With Social Anxiety Disorder (SAD). Neuroscience Education Institute (NEI) Annual Meeting

November 10, 2023

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Itruvone

Itruvone (PH10) Publications

Monti, L. et al. (2025). Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy Subjects. 2025 American Society of Clinical Psychopharmacology (ASCP

September 26, 2025

Anderson, T and Hong, C (2024). Pherines in Psychiatry: A Potential New Paradigm for the Treatment of Mental Disorders. The American Journal of Psychiatry Residents’ Journal | December 2024

December 6, 2024

Monti, L. et al. (2024). Itruvone Nasal Spray Depolarizes Electrogram of Nasal Receptors and Increases Gamma Bandwidth of the Olfactory Bulb Electrogram in Health Subjects. 2024 Neuroscience Education Institute (NEI) Congress.

November 11, 2024

Cato, J., Baker, R., & Monti, L. (2024). Brain and Peripheral Tissue Distribution of Intranasal Radio-labeled Itruvone (PH10) in Laboratory Rats. American Society of Clinical Psychopharmacology (ASCP) 2024 Annual Meeting.

May 29, 2024

Monti, L., & Liebowitz, M. (2022). Neural Circuits of Anxiolytic and Antidepressant Pherine Molecules. CNS Spectrums, 2022 Feb;27(1):66-72. doi: 10.1017/S109285292000190X

October 23, 2022

Monti, L., Smith, M., & Hanover, R. (2022). PH10: A new intranasal neuroactive steroid with rapid onset of antidepressant effect but a mechanism of action different from GABA‐A allosteric modulator antidepressants. Anxiety and Depression Association of Am

March 19, 2022

Monti, L., Nicolini, H., Liebowitz, M., & Hanover, R. (2019). “A Placebo Controlled Trial of PH10: Test of a New Rapidly Acting Intranasally Administered Antidepressant.” Br J Phar Med Res 4(6): 2157-2168.

November 13, 2019

Jancin, B. Novel intranasal antidepressant shows results after 1 week; Clinical Psychiatry News, Jun 20 2013.

June 20, 2013

PH10 May be a new rapidly acting Intranasally administered antidepressant; New Clinical Drug Evaluation Unit (NCDEU), 2013: 35-36.

May 28, 2013

PH80

Refisolone (PH80) Publications

Monti, L., et al (2025). Refisolone PH80 Nasal Spray Effects on In Vitro Receptor Binding, Reproductive Organs in Mice, and Pharmacokinetic Profile in Humans. The Menopause Society 2025 Annual Meeting.

November 25, 2025

Monti, L., et al (2025). Refisolone PH80 Nasal Spray Effects on Brain and Autonomic Activity: A Novel, Investigational, Rapid-Onset Non-Hormonal Treatment for Vasomotor Symptoms Due to Menopause. The Menopause Society 2025 Annual Meeting.

November 25, 2025

Monti, L. et al. (2024). Pain Symptom Cluster Analysis from the Daily Symptom Report in a Phase 2a Study of Refisolone PH80 for the Treatment of Premenstrual Dysphoric Disorder (PMDD). 2024 Neuroscience Education Institute (NEI) Congress.

November 11, 2024

Monti, L. et. al. (2024) Refisolone PH80 Nasal Spray for Treatment of Vasomotor Symptoms (Hot Flashes) Associated with Menopause: Phase 2 Randomized, Controlled Study. The Menopause Society 2024 Annual Meeting.

September 10, 2024

Monti, L. et. al. (2024). Refisolone PH80 Nasal Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder: Results from a Phase 2A Study. Anxiety and Depression Association of America (ADAA) 2024 Conference.

April 13, 2024

Monti,L.,Baker,R.,et.al.(2023).A Phase 2A Clinical Study to Investigate the Efficacy,Safety, and Tolerability of Refisolone PH80 for the Acute Management of Menopausal Vasomotor Symptoms (Hot Flashes) in Women.Neuroscience Education Institute (NEI) Annual

November 10, 2023

AV-101

AV-101 Publications

Patel, W. et.al. (2024). Role of Transporters and Enzymes in Metabolism and Distribution of 4-Chlorokynurenine (AV-101). Molecular Pharmaceutics 2024 21 (2), 550-563. DOI: 10.1021/acs.molpharmaceut.3c00700.

May 21, 2024

Bourque, M., Grégoire, L., Patel, W., Dickens, D., Snodgrass, R., & Di Paolo, T. (2022). AV-101, a Pro-Drug Antagonist at the NMDA Receptor Glycine Site, Reduces L-Dopa Induced Dyskinesias in MPTP Monkeys. Cells, 11(22), 3530.

November 8, 2022

Abbasi J. Ketamine Minus the Trip: New Hope for Treatment-Resistant Depression. JAMA. Published online November 08, 2017. doi:10.1001/jama.2017.12975

November 28, 2017

Wallace, M., et al. (2017) “Randomized, double-blind, placebo-controlled, dose-escalation study: Investigation of the safety, pharmacokinetics, and antihyperalgesic activity of L-4-chlorokynurenine in healthy volunteers.” Scandinavian Journal of Pain…

October 1, 2017

Yaksh, T.L., et al. (2017). “Characterization of the Effects of L-4-Chlorokynurenine on Nociception in Rodents.” The Journal of Pain 18: 1184-1196.

April 18, 2017

Gerhard, D. M., et al. (2016) "Emerging treatment mechanisms for depression: focus on glutamate and synaptic plasticity." Drug Discov Today 21:454-464

March 16, 2016

Li, C., et. al. (2016) “Activation of hippocampal BDNF signaling is involved in the antidepressant-like effect of the NMDA receptor antagonist 7-chlorokynurenic acid.” Brain Research 1630:73-82

January 1, 2016

Zanos, P., et al. (2015) "The Prodrug 4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but Not Side Effects, by NMDA/GlycineB-Site Inhibition." J Pharmacol Exp Ther 355:76-85

July 29, 2015

Bay-Richter, C., et al. (2015) "A role for inflammatory metabolites as modulators of the glutamate N-methyl-d-aspartate receptor in depression and suicidality." Brain Behav Immun 43:110-117

January 1, 2015

Murrough, J. W., et al. (2013) "Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial." Am J Psychiatry 170:1134-1142

October 1, 2013

Schwarcz, R., et al. (2012) "Kynurenines in the mammalian brain: when physiology meets pathology." Nat Rev Neurosci 13:465-477

July 1, 2013

Zarate, C. A., Jr., et al. (2006) "A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression." Arch Gen Psychiatry 63:856-864

August 1, 2006

Kemp, J. A., et al. (1988). "7-Chlorokynurenic acid is a selective antagonist at the glycine modulatory site of the N-methyl-D-aspartate receptor complex." Proc Natl Acad Sci USA 85:6547-6550.

May 16, 1988

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