Priligy (dapoxetine) / AbbVie - LARVOL DELTA

Unraveling the Anticancer Potential of SSRIs in Prostate Cancer by Combining Computational Systems Biology and In Vitro Analyses. (PubMed, ACS Omega) - "The combination of SSRIs with cisplatin, 5-fluorouracil, and raloxifene resulted in either synergistic or additive effects...Dapoxetine, paroxetine, and sertraline resulted in cell cycle arrest at the G0/G1 phase...At the same time, sertraline decreases the expression of Bcl-2 and VEGF and increases the expression of CASP8 and DR5. Results revealed that SSRIs can potentially act as antiproliferative agents against prostate cancer cells, and their activity is mediated through different signaling pathways."

IO biomarker • Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ANXA5 • BCL2 • CASP8

Evaluating the Safety and Clinical Impact of Selective Dorsal Neurotomy in Lifelong Premature Ejaculation: A Multi-Center Prospective Study (AUA 2025) - "Medical treatments included a Serotonin Reuptake Inhibitor (dapoxetine) and a topical anesthetic (lidocaien)... SDN appears to be an effective and safe treatment option for lifelong PE patients who do not respond to medication or prefer to avoid oral treatments. The procedure significantly increased IELT, improved IIEF scores, and decreased PEDT scores without serious postoperative complications, suggesting that SDN may be a viable alternative for treating PE."

Clinical • Anesthesia • Erectile Dysfunction • Infectious Disease • Sexual Disorders • Urology

British Society for Sexual Medicine (BSSM) Position statement on Premature Ejaculation. (PubMed, World J Mens Health) - "The British Society for Sexual Medicine (BSSM) takes issue with the advice to use off label treatments, such as daily selective serotonin reuptake inhibitors treatment, favoring on-demand dapoxetine...As a result, general practitioners in the UK have relied on local guidance, and international guidelines which are heterogeneous, indicating diagnostic and therapeutic approaches that are often inconsistent. The aim of this position statement is to improve the management of PE in the UK."

Journal • Review • Endocrine Disorders • Erectile Dysfunction • Sexual Disorders

Manganese(I)-Catalyzed Enantioselective Formal Anti-Markovnikov Hydroalkoxylation of Racemic Allylic Alcohols: A Borrowing Hydrogen Access. (PubMed, Org Lett) - "The synthetic utility of this protocol was further proven by gram-scale synthesis of chiral γ-alkoxypropanol 3n and derivatization of chiral γ-alkoxypropanol 3a to a drug molecule, (S)-dapoxetine, for the treatment of premature ejaculation and erectile dysfunction. Mechanistic studies support that the reaction proceeds via a hydrogen-borrowing cascade reaction pathway."

Journal • Erectile Dysfunction • Sexual Disorders

Global Andrology Forum Clinical Practice Guidelines on the Management of Premature Ejaculation. (PubMed, World J Mens Health) - "This global survey highlights significant diversity in the diagnostic and treatment strategies for PE. Standard diagnostic criteria are generally accepted, off-label medication is widely used in therapy, and the role of surgery is still controversial. A multi-modal therapy approach, tailored to the patient's specific needs, is favored. Further research into the neurobiology of PE and the development of effective and safe options is crucial for improving the management of PE."

Clinical guideline • Journal • Diabetes • Erectile Dysfunction • Metabolic Disorders • Sexual Disorders • Urology

Development and in vitro/in vivo evaluation of taste-masked orodispersible films of dapoxetine hydrochloride using ion exchange resins. (PubMed, Drug Deliv Transl Res) - "It was found that the based-Kyron T-134 resin complex achieved a high drug loading of 75.9 ± 1.4%, establishing the mass ratio of dapoxetine hydrochloride to Kyron T-134 at 2:1, and adjusting the solution pH to 5.4 ± 0.05. Furthermore, pharmacokinetic studies conducted in healthy volunteers demonstrated that the ODFs were bioequivalent to Priligy®. Therefore, this ODFs, characterized by its pleasant taste and water-free administration, offer a novel and convenient oral formulation for patients with PE, thereby enhancing patient compliance."

Journal • Preclinical • Sexual Disorders

Promising selective alpha-1 blocker silodosin as a new therapeutic strategy for premature ejaculation and analysis of its drug adverse effect: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Arch Ital Urol Androl) - "Silodosin significantly increased IELT. However, it also reduced semen ejaculation as its drug adverse effect. This result supports the clinical use of silodosin as an alternative treatment for premature ejaculation."

Adverse events • Clinical • Journal • Retrospective data • Review • Sexual Disorders

Primary premature ejaculation of kidney deficiency and liver stagnation treated with warm acupuncture of large-quantity moxibustion: a randomized controlled trial (PubMed, Zhongguo Zhen Jiu) - "Warm acupuncture with large-quantity moxibustion ameliorates the clinical symptoms and increases intravaginal ejaculation latency time and the levels of sex hormone in the patients with primary premature ejaculation (kidney deficiency and liver stagnation)."

Clinical • Journal • CNS Disorders • Fatigue • Insomnia • Sexual Disorders • Sleep Disorder • Urinary Incontinence

Toxicologic analysis of 35 drugs in post mortem human blood samples with focus on antihypertensive and antiarrhythmic drugs. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Therefore, a novel analytical method was developed and validated for the quantification of 35 drugs with toxicological relevance, including antihypertensive and antiarrhythmic drugs (ajmaline, amlodipine, amiodarone, atenolol, bisoprolol, carvedilol, clonidine, desethylamiodarone, diltiazem, donepezil, doxazosin, dronedarone, esmolol, flecainide, lercanidipine, lidocaine, metoprolol, nebivolol, nimodipine, pindolol, prajmaline, propafenone, propranolol, sotalol, urapidil, and verapamil), as well as other medications commonly found in combination (sildenafil, tadalafil, atorvastatin, clopidogrel, dapoxetine, memantine, pentoxifylline, rivastigmine, and ivabradine). In addition, the method was specifically tested for the use in post mortem analysis. The applicability of our method was demonstrated by the analysis of two authentic human autopsy blood samples."

Journal

TENSPE2: Effectiveness and Safety of TENS Therapy for Premature Ejaculation (clinicaltrials.gov) - P3 | N=129 | Recruiting | Sponsor: Boston Medical Group

New P3 trial • Sexual Disorders

Pharmacological Management of Premature Ejaculation: A Systematic Review and Bayesian Network Meta-analysis (AUA 2024) - "Overall, the highest MD compared to placebo was with pre-intercourse dapoxetine 30 mg+mirodenafil 50 mg (MD 280...Interestingly, lower doses of pre-intercourse tramadol (25 mg and 50 mg) also demonstrated a significant increase in IELT compared to a placebo, but this effect was not observed with higher doses (62 mg and 89 mg)... In conclusion, our results show that pre-intercourse therapies appear to correlate with the highest MD in IELT compared to placebo. Knowledge from this study will aid the urologist in selecting pharmacological treatments most likely to benefit patients with PE."

Retrospective data • Review • CNS Disorders • Sexual Disorders • Urology

A sustainable model for the simultaneous determination of tadalafil and dapoxetine hydrochloride in their binary mixture: Overcoming the challenges of environmental, operational, and instrumental variability for spectral data. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "Subsequently, PLS was applied for the simultaneous determination of tadalafil (TD) and dapoxetine hydrochloride (DP) in their binary mixture. Validation of the proposed method through accuracy profiles demonstrated its reliability, paving the way for its application in pharmaceutical analysis."

Journal

Research progress of combination therapy in the treatment of erectile dysfunction and premature ejaculation comorbidity (PubMed, Zhonghua Nan Ke Xue) - "In recent years, multi-country clinical guidelines have provided suggestions and guidance for the combination of these two drugs, with the safety and effectiveness being further explored and verified. This review summarized the status of ED and PE comorbidity, treatment principles, and research progress on the safety and effectiveness of Dapoxetine combined with PDE5i, in order to provide reference for the combination therapy of ED and PE comorbidity."

Combination therapy • Journal • Erectile Dysfunction • Sexual Disorders

Clinical observation of dapoxetine combined with percutaneous neuromuscular electrical stimulation in the treatment of primary premature ejaculation (PubMed, Zhonghua Nan Ke Xue) - "Dapoxetine combined with TNES has a better clinical effect than dapoxetine alone in the treatment of primary premature ejaculation, and can be used as an effective option for clinical treatment of primary premature ejaculation."

Journal • CNS Disorders • Depression • General Anxiety Disorder • Mood Disorders • Psychiatry • Sexual Disorders

Correlation between serum tryptophan metabolism and treatment efficacy of dapoxetine in patients with premature ejaculation: A pilot study. (PubMed, Andrology) - "This study demonstrates that the reduction in the TRP/LNAAs ratio and the elevation of the KYN/TRP ratio are significant characteristics associated with PPE. These findings suggest that diminished tryptophan availability in the brain and the activation of the kynurenine (KYN) pathway may play a role in the pathogenesis of PPE. The TRP/LNAAs ratio has potential as a reliable indicator of central serotonin (5-HT) levels. Considering the TRP/LNAAs ratio when selecting SSRIs for the treatment of PPE may enhance the response rate of this medication."

Journal • Sexual Disorders

Effect of Serum Vitamin B12 Levels on Premature Ejaculation. (PubMed, J Coll Physicians Surg Pak) - "Vitamin B12 deficiency can reduce the effectiveness of dapoxetine treatment in patients with PE. It is important to evaluate serum vitamin B12 levels for the evaluation of patients with PE."

Journal • Sexual Disorders

Dapoxetine versus glans penis injection with hyaluronic acid gel in treatment of premature ejaculation. (PubMed, Arab J Urol) - "However, when comparing the improvement of ILET in group A (Dapoxetine) and group B (HA injection), there were high significance differences in favor of group B in the 1st,3rd, and 6th-month follow-up. Although both treatment modalities have improved IELT and premature ejaculation, but HA injection with five punctures technique was significantly better than oral Dapoxetine with self-limited side effects."

Journal • Sexual Disorders

Prospective comparison of tadalafil 5 mg, dapoxetine 30 mg, and the combination of both in the treatment of premature ejaculation. (PubMed, Arab J Urol) - "Post hoc analysis suggested this improvement was more pronounced in group C (P < 0.001). Both tadalafil and dapoxetine are effective in the treatment of patients with premature ejaculation, but the combination of both drugs gives better results."

Journal • Sexual Disorders

Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions. (PubMed, Clin Pharmacol Drug Dev) - "In addition, both dapoxetine hydrochloride formulations were generally well tolerated. The generic dapoxetine hydrochloride tablet was bioequivalent to the marketed reference product in healthy Chinese men with no discernible safety differences."

Journal • Sexual Disorders

One-drop chemosensing of dapoxetine hydrochloride using opto-analysis by multi-channel μPAD decorated silver nanoparticles: introducing a paper-based microfluidic portable device/sensor toward naked-eye pharmaceutical analysis by lab-on-paper technology. (PubMed, RSC Adv) - "For the first time, in order to provide a simple and portable colorimetric/spectrophotometric recognition system to sensitive determination of DPX, an optimized pump-less microfluidic paper-based colorimetric device (μPCD) was introduced and validated for the real-time biomedical analysis of this analyte. According to the obtained results, this alternative approach is suitable for therapeutic drug monitoring (TDM) and biomedical analysis by miniaturized and cost-beneficial devices."

Journal

Dapoxetine, a Selective Serotonin Reuptake Inhibitor, Suppresses Zika Virus Infection In Vitro. (PubMed, Molecules) - "Moreover, cell fluorescence staining and Western blotting assays revealed that dapoxetine effectively reduced the expression of ZIKV proteins. Collectively, our findings suggest that dapoxetine exhibits anti-ZIKV effects by inhibiting ZIKV RdRp activity, positioning it as a potential candidate for clinical therapeutic intervention against ZIKV infection."

Journal • Preclinical • Infectious Disease • Sexual Disorders

Effects of CYP2D6 *10 and *41 Variants in Healthy Chinese Men on the Pharmacokinetics of Dapoxetine. (PubMed, J Clin Pharmacol) - "The AUC increased significantly (154% and 89.73%, p ? 0.05), and the C increased significantly (73.45% and 42.67%, p ? 0.05) when comparing CYP2D6 *10/*41 subjects to *1/*1 and *1/*10 subjects. The obtained results indicated that CYP2D6 *10 and *41 polymorphisms have significant effects on the pharmacokinetic properties of dapoxetine."

Journal • PK/PD data • Sexual Disorders • CYP3A4

A Telescoped Continuous Flow Enantioselective Process for Accessing Intermediates of 1-Aryl-1,3-diols as Chiral Building Blocks. (PubMed, J Org Chem) - "A telescoped continuous flow process is reported for the enantioselective synthesis of chiral precursors of 1-aryl-1,3-diols, intermediates in the synthesis of ezetimibe, dapoxetine, duloxetine, and atomoxetine. The two-step sequence consists of an asymmetric allylboration of readily available aldehydes using a polymer-supported chiral phosphoric acid catalyst to introduce asymmetry, followed by selective epoxidation of the resulting alkene. The process is highly stable for at least 7 h and represents a transition-metal free enantioselective approach to valuable 1-aryl-1,3-diols."

Journal

Innovative and sustainable deconvoluted amplitude factor spectrophotometric method for the resolution of various severely overlapping pharmaceutical mixtures: Applying the complex-GAPI-tool. (PubMed, Heliyon) - "In this paper, we epitomize the newly developed deconvoluted amplitude factor (DAF) spectrophotometric approach which couples the concepts of both the FSD and the amplitude factor methods for the resolution of tadalafil (TAD) in its binary mixtures with dapoxetine hydrochloride (DAP) or tamsulosin hydrochloride (TAM). The method was validated as per ICH guidelines recommendations and also was statistically compared with recently reported methods which revealed no statistically significant difference. A very handy and reader-friendly data presentation approach was followed for the ease of statistical data interpretation and evaluation."

Journal

Topical Anesthetics and Premature Ejaculation: A Systematic Review and Meta-Analysis. (PubMed, Cureus) - "Similarly, the topical eutectic mixture for premature ejaculation (TEMPE), lidocaine, and the eutectic mixture of local anesthetics (EMLA) were significantly more efficient than a placebo (P<0.00001; P = 0.0001; P<0.00001). Additionally, it was found that lidocaine gel was more efficient than paroxetine or sildenafil (P = 0.04; P<0.00001). In conclusion, topical anesthetics increase IELT in men with premature ejaculation more effectively than placebo, sildenafil, tadalafil, paroxetine, and dapoxetine."

Journal • Retrospective data • Review • Anesthesia • Sexual Disorders