Addyi (flibanserin) / Sprout Pharma - LARVOL DELTA

Oxytocin for male orgasmic disorder: fact or fiction? (AUA 2025) - "This starts with vibratory stimulation, followed by oxytocin, bupropion, and cabergoline, and finally bremelanotide and flibanserin. Intranasal oxytocin failed to significantly improve orgasmic disorder in the majority of men in our cohort. Male orgasmic disorder remains a difficult to treat condition. A significant proportion of patients with orgasmic disorder are co-morbid with erectile dysfunction and a psychiatric diagnosis, most commonly major depressive disorder."

CNS Disorders • Depression • Endocrine Disorders • Erectile Dysfunction • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sexual Disorders

HSDD: Hypoactive Sexual Desire Disorder in Males (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mohit Khera | Trial primary completion date: Oct 2024 ➔ Oct 2025

Trial primary completion date • Sexual Disorders

Novel Pharmacologic Treatments of Female Sexual Dysfunction. (PubMed, Clin Obstet Gynecol) - "We provide clinically relevant applications for Food and Drug Administration (FDA)-approved medications (flibanserin and bremelanotide) and investigational therapies (Lorexys and testosterone combinations). Detailed study outcomes, safety profiles, and clinical strategies guide clinicians in appropriate diagnosis, patient selection, expectation setting, side effect management, and patient education, improving treatment outcomes and patient satisfaction."

Journal • Review • Sexual Disorders

Gap in Sexual Dysfunction Management Between Male and Female Patients Seen in Primary Care: An Observational Study. (PubMed, J Gen Intern Med) - "Primary care patients with FSD are less likely to receive management if they are diagnosed by a PCP than by an OB/GYN. The opposite was true of ED patients, exposing a gap in the quality of care female patients receive."

Journal • Observational data • Erectile Dysfunction • Pain • Sexual Disorders • Urology • Women's Health

Flibanserin conquers murine depressive pseudodementia by amending HPA axis, maladaptive inflammation and AKT/GSK/STAT/BDNF trajectory: center-staging of the serotonergic/adrenergic circuitry. (PubMed, Eur J Pharmacol) - "This study tested the procognitive potential of Flibanserin (FBN), the serotonin (5HT) receptor modulator, against propranolol (PRP), as β/5HT1A receptors blocker. Pre-administration of PRP partially abolished FBN effect along the estimated parameters, except for 5HT2A receptor expression and epinephrine level, to prove 5HT1A receptor as a fulcrum initiator of the investigated pathway, while its sole administration worsened the underlying condition. Ultimately, these findings highlight the immense procognitive potential of FBN, offering a new paradigm for halting DPD advancement via synchronizing adrenergic/serotonergic circuitry."

Journal • Preclinical • CNS Disorders • Cognitive Disorders • Inflammation • Oncology • BDNF • CD68 • GFAP • NPHS1 • TNFA

Understanding the Interplay Between Premenstrual Dysphoric Disorder (PMDD) and Female Sexual Dysfunction (FSD). (PubMed, Cureus) - "Selective serotonin re-uptake inhibitors (SSRIs) and combined oral contraceptive pills (COCPs) are approved medications for PMDD, while flibanserin and bremelanotide are effective in treating FSD. However, the potential effects of these treatment modalities on the two comorbid conditions render them inconclusive. Awareness of PMDD and FSD among clinicians and society can allow the implementation of targeted interventions to alleviate the suffering of women and enhance their quality of life."

Journal • Review • CNS Disorders • Depression • Gynecology • Mood Disorders • Psychiatry • Sexual Disorders • Women's Health

Role of flibanserin in managing hypoactive sexual desire disorder in women: A systematic review and meta-analysis. (PubMed, Medicine (Baltimore)) - "While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Fatigue • Insomnia • Sexual Disorders • Sleep Disorder

Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women. (PubMed, Ann Pharmacother) - "Through a literature search on PubMed, Google Scholar, and ClinicalTrials.gov from 1999 to 2024, studies were selected using the following MeSH search terms: hypoactive sexual desire disorder, premenopause, pharmacologic management, flibanserin, bremelanotide, buspirone, bupropion, and testosterone, excluding those involving postmenopausal women or other sexual disorders. Further research with the most suitable clinical endpoints and consideration of patient factors are crucial before widespread adoption of flibanserin and bremelanotide. Pharmacists are encouraged to embrace this opportunity to provide premenopausal HSDD care in ambulatory and community practice settings."

Journal • Review • Sexual Disorders • Women's Health

Effects of Flibanserin on the Pre- and Post-menopausal Female Brain (clinicaltrials.gov) - P=N/A | N=57 | Terminated | Sponsor: University of Chicago | Active, not recruiting ➔ Terminated; PI left institution cannot be contacted.

Trial termination • Sexual Disorders

RAD 2003: Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (clinicaltrials.gov) - P2 | N=44 | Active, not recruiting | Sponsor: Andrew McDonald | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Benchtop NMR Coupled with Chemometrics: A Workflow for Unveiling Hidden Drug Ingredients in Honey-Based Supplements. (PubMed, Molecules) - "The investigation unveiled the presence of tadalafil in 37 samples, sildenafil in 5 samples, and a combination of flibanserin with tadalafil in 1 sample. Additionally, PLS regression models are employed to predict the quantitative content of these adulterants. Through blind analysis, this workflow allows for the detection and quantification of adulterants in these honey supplements."

Journal

Zirconium-based hydrophobic-MOFs as innovative electrode modifiers for flibanserin determination: Exploring the electrooxidation mechanism using a comprehensive spectroelectrochemical study. (PubMed, Mikrochim Acta) - "The applicability of the developed approach was demonstrated by determination of FLB in pharmaceutical tablets and human urine samples with acceptable repeatability (% RSD values were below 1.9% and 2.1%, respectively) and reasonable recovery values (ranged between 97 and 103% for pharmaceutical tablets and between 96 and 102% for human urine samples). The outcomes of the suggested methodology can be utilized for the determination of other hydrophobic compounds of pharmaceutical or biological interest with the aim of achieving low detection limits of these compounds in various matrices."

Journal

Highly sensitive plasmonic paper substrate fabricated via amphiphilic polymer self-assembly in microdroplet for detection of emerging pharmaceutical pollutants. (PubMed, Nano Converg) - "The nanohybridized plasmonic paper was successfully applied to detect two emerging pollutants-sildenafil and flibanserin-with LODs as low as 1.48 nM and 3.45 nM, respectively. Thus, this study offers new prospects for designing an affordable and readily available, yet highly sensitive, paper-based SERS substrate with the potential for development as a lab-on-a-chip device."

Journal

Identifying novel aryl hydrocarbon receptor (AhR) modulators from clinically approved drugs: In silico screening and In vitro validation. (PubMed, Arch Biochem Biophys) - "This included flibanserin, butoconazole, luliconazole, naftifine, triclabendazole, rosiglitazone, empagliflozin, benperidol, nebivolol, and zucapsaicin. Importantly, these findings hold immense therapeutic potential for addressing AhR-associated disorders. Consequently, it offers compelling prospects for innovative interventions through drug repurposing."

Journal • Preclinical • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Solid Tumor

RAD 2003: Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Andrew McDonald | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

HSDD: Hypoactive Sexual Desire Disorder in Males (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mohit Khera | Trial completion date: Oct 2025 ➔ Dec 2026

Trial completion date • Sexual Disorders

Understanding Hypoactive Sexual Desire Disorder (HSDD) in Women: Etiology, Diagnosis, and Treatment. (PubMed, Cureus) - "Novel treatments like bremelanotide, flibanserin, and integrative strategies combining psychotherapy and lifestyle changes are discussed. Challenges and controversies surrounding HSDD, including the lack of consensus on diagnostic criteria, debates about the medicalization of sexuality, ethical concerns regarding pharmaceutical interventions, and cultural considerations, are addressed. Future directions in research, including advances in neurobiological understanding, personalized medicine, long-term treatment studies, and destigmatization initiatives, offer promising pathways for enhancing the management of HSDD."

Journal • Review • CNS Disorders • Mental Retardation • Psychiatry • Sexual Disorders

What Women Want? The State of the Art regarding the Treatment of Young Women with Hypoactive Sexual Desire Disorder. (PubMed, Pharmacology) - "The treatment of HSDD in young women requires a mixed treatment approach that addresses the disorder's complexity. Despite clinicians seeming to be divided between using pharmacological and/or psychosocial approaches, some women might respond better to one type of intervention over the others. This calls for the development of tools that assess the best approach for each person, including their will and informed choice."

Journal • Review • CNS Disorders • Depression • Psychiatry • Sexual Disorders

Repurposing Drugs for Treatment of Age-Related Macular Degeneration. (PubMed, Adv Exp Med Biol) - "This short review summarizes progress in several classes of drugs considered for repurposing: GPR-143 agonists (L-DOPA), anti-diabetic drugs (metformin, acarbose, empagliflozin, fenofibrate), mitochondrial activators (PU-91), and serotonin pathway drugs (fluoxetine, flibanserin, xaliproden, buspirone). The promises and caveats of repurposing are discussed herein."

Journal • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • GPR143

RAD 2003: Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Andrew McDonald | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Different Perspective on the Characterization of a New Degradation Product of Flibanserin with HPLC-DAD-ESI-IT-TOF-MSn and its Pharmaceutical Formulation Analysis with Inter-Laboratory Comparison. (PubMed, J AOAC Int) - "A novel stability indicating assay method was developed and fully validated according to ICH (Q2)R1 for the analysis of FLB in the pharmaceutical preparations. A new degradation product was identified in the oxidative forced degradation condition and characterized using HPLC-DAD-ESI-IT-TOF-MS3. Moreover, the possible mechanism and the formation kinetic of the degradation product were revealed. In addition, the developed method was transferred to another LC-PDA instrument for inter-laboratory comparison. Finally, the current method was applied to pseudo formulation of Addy® in both instruments and ANOVA was applied for evaluation."

Journal • Sexual Disorders

Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy. (ASCO 2023) - P=N/A | "Our study found statistically significant improvement in the sexual domains of desire, arousal, lubrication, orgasm, satisfaction, and pain as measured by the FSFI from baseline to week 24 while on Flibanserin. It also showed improved overall health-related quality of life and sleep. Flibanserin is an effective treatment option for women with breast cancer."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Pain • Solid Tumor

Sprout Pharmaceuticals Announces Release of Abstract Reporting Positive Interim Results for Flibanserin in Breast Cancer Patients Suffering from Low Libido for Poster Discussion at 2023 ASCO Annual Meeting (PRNewswire) - "Sprout Pharmaceuticals, Inc...announced publication of abstract 12015 by the American Society of Clinical Oncology (ASCO). The abstract reporting positive interim results for the use of Addyi (flibanserin) tablets in breast cancer patients with low libido has been accepted for presentation in a Poster Discussion Session at the ASCO 2023 Annual Meeting being held virtually and in Chicago, IL from June 2-6, 2023."

Clinical data • Breast Cancer • Oncology • Solid Tumor

A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors (clinicaltrials.gov) - P=N/A | N=43 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Sep 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sexual Disorders • Solid Tumor • PGR

Cardioprotective Effect of Flibanserin against Isoproterenol-Induced Myocardial Infarction in Female Rats: Role of Cardiac 5-HT2A Receptor Gene/5-HT/Ca Pathway. (PubMed, Pharmaceuticals (Basel)) - "However, pretreatment with FLP significantly attenuated the ISO-induced MI in a dose-dependent manner, as the effect of FLP (45 mg/kg) was more pronounced than that of the other two doses, FLP (15 and 30 mg/kg). The present study provides evidence for the cardioprotective efficacy of FLP against ISO-induced MI in rats."

Journal • Preclinical • Cardiovascular • Myocardial Infarction • Myocardial Ischemia