LTR Pharma starts US ROXUS fulfilment as SPONTAN advances toward Phase III

ROXUS moves from agreements to US prescriptions

LTR Pharma Limited (ASX:LTP) has reached the more commercially meaningful stage of its US launch: patient-specific ROXUS prescriptions have been fulfilled. The first prescriptions came through Shed’s Mavrox telehealth platform and were dispensed by Strive Pharmacy on 6 October, less than three months after the two definitive agreements were signed.

The milestone follows the US ROXUS commercial agreements, which established the telehealth and pharmacy components of the launch. Shed is responsible for patient acquisition, platform operations, clinical infrastructure and marketing, while Strive covers compounding, quality systems, active pharmaceutical ingredient sourcing, fulfilment and nationwide supply. LTR Pharma remains the product owner, intellectual property holder and supplier.

The filing does not provide prescription volumes, revenue guidance or a forecast for how quickly activity might build. It also stresses that ROXUS is a compounded medication prepared for identified individual patient needs and is not reviewed or approved by the US Food and Drug Administration for safety or efficacy. The commercial test now is whether initial fulfilment develops into sustained prescribing activity.

SPONTAN completes FDA-aligned pharmacokinetic work

SPONTAN’s final Phase II clinical study report confirms the rapid absorption signal that underpins LTR Pharma’s US development plans. In the 27-person study, the 5 mg dose reached median peak concentration in 10 minutes, compared with 60 minutes for a 20 mg oral vardenafil tablet; the difference was statistically significant, with a reported p-value below 0.0001.

The report, prepared by Southern Star Research, completes the pharmacokinetic dataset agreed with the FDA for a planned 505(b)(2) submission. The cohort included 14 participants aged 65 and over, whose pharmacokinetics were described as comparable with younger adults. No serious adverse events, Grade 3 or higher treatment-emergent adverse events or discontinuations were reported in the study. The dataset measures absorption and exposure, however, rather than demonstrating efficacy in an erectile dysfunction patient population.

With the final Phase II pharmacokinetic report now complete, LTR Pharma says it is working through chemistry, manufacturing and controls documentation, human factors validation, leachables and non-clinical toxicology. A Phase III study is targeted to begin in the first half of calendar 2027, subject to the company’s planned development timetable.

Australian dispensing adds real-world evidence

SPONTAN’s Australian access programme passed 2,000 bottles dispensed by 20 October under the Therapeutic Goods Administration’s Special Access Scheme and Authorised Prescriber pathways. More than 120 clinicians had prescribed the product on more than one occasion, with use reported across all six states and the Australian Capital Territory.

The company also highlighted a retrospective 147-patient real-world cohort in which 93% of men seeking greater convenience and spontaneity met the study’s composite endpoint. The corresponding result was 64% among post-prostatectomy patients and 68% across the full cohort, while 57% of men seeking improved efficacy after inadequate response to oral therapy met the endpoint. The 147-patient real-world study was based on treatment-experienced men in routine Australian practice, and its manuscript remains under peer review.

Cash position supports the next development cycle

LTR Pharma held A$18.2 million in cash and no debt at 30 September. Net operating cash outflow was A$1.6 million for the quarter, including A$0.6 million in research and development spending. On the reported quarterly outflow, the Appendix 4C estimates around 11 quarters of funding, although that calculation assumes cash usage remains broadly unchanged.

Customer receipts totalled A$366,035, including about A$70,000 from SPONTAN supply in Australia and A$296,000 from ROXUS raw materials. The latter receipts related to supply rather than patient prescriptions, which began only after the reporting period. The company also received ethics approval for an investigator-initiated pulmonary arterial hypertension study and expects to begin that work in the first half of calendar 2027, while an OROFLOW pilot study is slated for the second half of calendar 2026.