LTR Pharma reports encouraging real-world data
Real-world data from a study on intranasal erectile dysfunction treatment SPONTAN shows a 93% response rate among men seeking greater convenience, according to LTR Pharma. The company reported encouraging results from a retrospective, single-centre study involving 147 patients with a mean age of 65.6 years. These findings, presented to the Australian Prostate Cancer Conference, suggest the rapid-acting therapy could address an unmet need for men who struggle with the timing of oral medications. LTR Pharma is focusing its commercial strategy on the U.S. market, where it is advancing SPONTAN through the FDA’s 505(b)(2) regulatory pathway.
The company has partnered with telehealth platform Shed and compounding pharmacy Strive Pharmacy to support its rollout. These agreements aim to bring ROXUS, a similar intranasal treatment, to patients under specific prescriptions. The data from this study may help the company target urologists and prescribers as it prepares for commercial availability. The manuscript detailing these findings has been submitted to the journal Sexual Medicine for peer review. [1]SRL shares rise on US loan deal
The cohort was split into two main groups: 45 men seeking greater convenience and spontaneity, and 102 men seeking improved efficacy after an inadequate response to oral therapy. Across the entire group of 147, 68% reported improved erectile hardness and/or achieving penetration. This figure rose to 57% for men who had previously reported failure with oral PDE5 inhibitors. The 93% response rate among those seeking convenience indicates that timing and ease of use are critical factors for many men managing the condition.
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Of the 87 patients who had undergone prostatectomy, 64% reported positive outcomes with the treatment. Oral PDE5 inhibitors like sildenafil and tadalafil often see response rates drop to approximately 12-17% during the first six months after surgery due to cavernous nerve injury. This real-world data suggests a potential alternative for this challenging patient population. The findings come at a time when the demand for non-invasive options is growing. Prostate cancer is the most diagnosed cancer in Australian men, with over 28,000 new cases projected for 2025.
In the U.S., more than 3.5 million men are living with a prostate cancer diagnosis. For men prescribed oral medications, the lack of spontaneity is a common reason for discontinuation, often leading to a cycle of treatment failure and frustration. The intranasal approach offers a different mechanism that bypasses the gastrointestinal system, potentially providing faster results without the need for water or timing.
