First ROXUS prescriptions fulfilled in the United States
LTR Pharma Limited (ASX: LTP) has announced that the first patient-specific ROXUS® prescriptions received through Mavrox, Shed’s men’s health telehealth platform, have now been fulfilled in the United States.
The milestone marks the commencement of ROXUS prescription activity under the telehealth and pharmacy arrangements established through the company’s agreements with Shed and Strive Pharmacy. The first prescriptions followed completion of the operational work required to support ROXUS prescription fulfilment in the United States.
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How the U.S. telehealth and pharmacy pathway works
Mavrox and Strive Pharmacy roles
Mavrox provides the initial U.S. direct-to-consumer telehealth route for ROXUS. Strive Pharmacy has established the operational systems required to receive, compound and fulfil valid patient-specific ROXUS prescriptions.
The Strive Pharmacy supply agreement completed the second commercial pillar for the U.S. launch, with Strive operating a Section 503A compounding platform licensed to support nationwide prescription fulfilment and shipping.
The Shed telehealth agreement carries a first-year commitment of 150,000 ROXUS units and grants Shed two years of direct-to-consumer exclusivity, which frames the scale of prescription activity the Mavrox route is expected to support.
The pathway runs in three steps:
- A patient-specific prescription is received through Mavrox.
- The prescription comes from a prescribing healthcare practitioner and must be valid.
- Strive Pharmacy compounds and fulfils the prescription.
Director commentary
LTR Pharma Executive Chairman Lee Rodne said the milestone reflects a shift in the company’s position.
Lee Rodne, Executive Chairman
“With our first prescriptions now received through Mavrox, we have moved from implementation to serving patients under these arrangements…”
Rodne also noted that the milestone came “less than three months after we announced our agreement with Shed to establish a U.S. telehealth route to patients.”
Compounded medication explained for investors
ROXUS is LTR Pharma’s intranasal medication for erectile dysfunction support. It is compounded and dispensed in the United States by a licensed pharmacy under the patient-specific compounding provisions of Section 503A of the US Federal Food, Drug, and Cosmetic Act.
A compounded medication is prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner. As such, ROXUS is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy, and prescribers are expected to use their independent clinical judgement when determining appropriateness for individual patients.
For investors, this route allows patient access in the U.S. through a licensed pharmacy rather than through a full FDA approval pathway. The announcement does not address any future approval plans.
| Element | Detail | Why it matters |
|---|---|---|
| Telehealth route | Mavrox (Shed) | Initial U.S. direct-to-consumer route for ROXUS |
| Pharmacy partner | Strive Pharmacy | Receives, compounds and fulfils valid patient-specific prescriptions |
| Legal basis | Section 503A, patient-specific compounding | Governs how ROXUS is compounded and dispensed in the U.S. |
What comes next for LTR Pharma
LTR Pharma will continue working with Shed and Strive Pharmacy to support ROXUS prescription fulfilment through Mavrox. The company will focus on supporting its U.S. partners as prescribing and prescription activity builds, and will provide further updates on U.S. prescription activity as meaningful information becomes available.
LTR Pharma describes itself as a commercial-stage pharmaceutical company that has commercialised its rapid-acting treatment technology in Australia. Its lead products, SPONTAN® and ROXUS®, are intranasal sprays for erectile dysfunction with onset of action in 10 minutes or less, while OROFLOW® is under development for Oesophageal Motility Disorders.
The announcement does not disclose prescription volumes, pricing or revenue. The key watch point for investors is how prescription activity develops through Mavrox and Strive Pharmacy.
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