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Oral spray sildenafil in erectile dysfunction: current evidence and clinical perspectives
Massimiliano Raffo1,2, Angelo Di Naro3, Giovanni Carbotti3
1Division of Experimental Oncology/Unit of Urology, URI-Urological Research Institute, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132, Milan, Italy. raffo.massimiliano@hsr.it.
Abstract:
Erectile dysfunction is one of the most prevalent male sexual disorders and is commonly managed with phosphodiesterase type 5 inhibitors, among which sildenafil remains the most widely prescribed agent. Conventional tablet formulations have demonstrated well-established efficacy and safety; however, treatment adherence is frequently influenced by factors beyond pharmacological effectiveness. In recent years, alternative sildenafil formulations, including oral spray systems, have been developed to improve treatment acceptability and potentially enhance the overall patient experience. This narrative review summarizes the current evidence regarding oral spray sildenafil, focusing on its pharmacological rationale, clinical efficacy, onset of action, safety, tolerability, patient experience, and potential role in clinical practice. Available evidence suggests that oral spray sildenafil may offer practical advantages, particularly for patients with swallowing difficulties or those seeking a less medicalized treatment experience. However, most currently available data derive from pharmacokinetic investigations or indirect comparisons with other alternative oral formulations, whereas direct comparative clinical studies remain scarce. Consequently, no consistent evidence currently demonstrates superior efficacy, faster onset of action, or improved safety compared with conventional tablet formulations. Likewise, formulation-specific data regarding patient-reported outcomes and real-world effectiveness remain limited. Oral spray sildenafil therefore represents an emerging alternative formulation that may improve treatment acceptability in selected patients, although its precise clinical role has yet to be established. Well-designed comparative clinical trials are warranted to clarify its therapeutic value and identify patient populations most likely to benefit from this delivery modality.
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