LTR Pharma’s SPONTAN Shows Strong Real-World Response in Post-Prostatectomy and Convenience-Seeking Men

High Response Rates in Convenience-Seeking and Post-Prostatectomy Groups

LTR Pharma (ASX:LTP) has unveiled compelling real-world evidence showcasing its rapid-onset intranasal erectile dysfunction (ED) treatment, SPONTAN. Among 147 treatment-experienced men, 93% of those seeking greater convenience and spontaneity reported improved erectile hardness and/or achieving penetration. This subgroup, comprising 45 men, highlights SPONTAN’s appeal beyond traditional efficacy concerns, tapping into a patient desire for spontaneity often unmet by oral PDE5 inhibitors.

Equally notable is the 64% response rate in the post-prostatectomy population, a notoriously difficult group to treat given the limited effectiveness of oral ED therapies like Viagra and Cialis following radical prostate surgery. Of 87 men in this subgroup, nearly two-thirds reported meaningful improvements, suggesting SPONTAN’s rapid intranasal delivery could fill a critical gap in early recovery when nerve damage impairs nitric oxide pathways essential for oral drug efficacy.

Addressing an Underserved Patient Population

Prostate cancer remains Australia’s most diagnosed male cancer, with nearly 29,000 new cases estimated in 2025 and around 8,500 radical prostatectomies annually. Erectile dysfunction affects up to 85% of men post-surgery, yet oral PDE5 inhibitors see dropout rates exceeding 50%, often due to lack of spontaneity. LTR Pharma’s data suggest SPONTAN could appeal both to men dissatisfied with oral treatments and those simply seeking a more convenient, rapid-acting option.

Within the overall cohort, 68% (100 of 147) reported improved erectile hardness and/or penetration, with 57% response among the 102 men who had previously found oral PDE5 inhibitors inadequate. This is a significant finding, given the entrenched challenge of treating ED in men with prior oral therapy failure.

Strategic Implications for US Commercialisation

These real-world outcomes arrive as LTR Pharma advances its US commercial strategy for SPONTAN and ROXUS, its rapid-acting intranasal ED treatment. The company has secured definitive agreements with Shed Holdings LLC and Strive Specialties Inc., positioning it for the anticipated US launch of ROXUS via telehealth and pharmacy channels. The post-prostatectomy subgroup data could prove particularly valuable in engaging urologists and men’s health prescribers, offering a non-invasive alternative to injectable therapies like CAVERJECT that require training and carry procedural burdens.

SPONTAN is currently supplied in Australia under Special Access and Authorised Prescriber schemes, with the submitted manuscript undergoing peer review in Sexual Medicine. The forthcoming presentation at the Asia Pacific Congress of Sexual Health in Melbourne will further spotlight these findings.

Clinical and Market Perspectives

Melissa Hadley Barrett, Nurse Practitioner and Sexologist, emphasised the significance of the response among men with prior treatment experience and prostate cancer history, noting the importance of timing and ease of use as clinical variables. Executive Chairman Lee Rodne highlighted that the data reinforce the opportunity for SPONTAN and ROXUS to extend beyond oral therapy failures, addressing a broader patient base seeking spontaneity and control.

While the retrospective, single-centre nature of the study and reliance on patient-reported outcomes warrant cautious interpretation, the dataset is the largest real-world cohort reported for SPONTAN to date. It underscores an unmet need in a large, durable patient population both in Australia and the United States, where prostate cancer incidence and ED prevalence continue to rise.