Australian-Developed ED Nasal Spray Now Being Prescribed in the U.S.

Highlights

• First patient-specific ROXUS^® prescriptions received through Mavrox, Shed's men's health telehealth platform, have now been fulfilled in the United States.
• Mavrox provides the initial U.S. direct-to-consumer telehealth route for ROXUS, with Strive Pharmacy supporting prescription compounding and fulfilment. 
• LTR Pharma will now focus on supporting its U.S. partners as prescribing and prescription activity builds.

SYDNEY, Oct. 8, 2026 /PRNewswire/ -- LTR Pharma Limited (ASX:LTP) has confirmed the first ROXUS^® prescriptions have been fulfilled in the United States. ROXUS is a prescription nasal spray that delivers vardenafil, an ED medicine used in tablet form for more than 20 years, through LTR's proprietary intranasal spray technology.

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 through the telehealth and pharmacy arrangements established under LTR Pharma's agreements with Shed and Strive Pharmacy.  The first prescriptions follow completion of the operational work required to support ROXUS prescription fulfilment in the United States.  

ROXUS is LTR Pharma's intranasal medication for erectile dysfunction support, 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.

The full ASX announcement is available here.

U.S. Prescription Fulfilment

Strive Pharmacy has established the operational systems required to receive, compound and fulfil valid patient-specific ROXUS prescriptions.

LTR Pharma Executive Chairman, Lee Rodne, said:

"Fulfilment of the first ROXUS prescriptions in the United States is an important milestone for LTR Pharma and our US partners.  With our first prescriptions now received through Mavrox, we have moved from implementation to serving patients under these arrangements.  Our focus is now on supporting our partners as prescribing and prescription activity builds.

"This milestone comes less than three months after we announced our agreement with Shed to establish a U.S. telehealth route to patients."

LTR Pharma Scientific Advisory Board member and Urologist, Dr Amy Pearlman, said:

"In sexual medicine, convenience is clinical. ROXUS gives us an opportunity to rethink delivery of a familiar PDE5 mechanism around the patient experience: speed, discretion and spontaneity."

Next Steps

LTR Pharma will continue working with Shed and Strive Pharmacy to support ROXUS prescription fulfilment through Mavrox.  The Company will provide further updates on US prescription activity as meaningful information becomes available. 

ROXUS is a compounded medication prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy.  Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug.  These statements have not been evaluated by the FDA.  Prescribers should use their independent clinical judgement when determining appropriateness for individual patients.

Now Live: Clinical and Commercial Webinar

LTR Pharma hosted an investor webinar on 6 October 2026 to examine the Company's latest clinical and commercial progress with SPONTAN^® and ROXUS^®. Session panellists included Sexologist and Nurse Practitioner Melissa Hadley Barrett, LTR Pharma Chief Medical Officer Professor Geoff Strange, and LTR Pharma Executive Chairman Lee Rodne.

Watch the webinar on the LTR Pharma YouTube channel here.

Forward-Looking Statement

This release contains forward-looking statements, including in relation to ongoing US prescription activity. These statements involve risks and assumptions beyond the Company's control, and actual results may differ materially.

About LTR Pharma

LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has successfully commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing regulatory pathways in the US and other key markets.

LTR's lead products, SPONTAN^® and Roxus^®, are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is now advancing OROFLOW^®, a novel intranasal spray under development for the treatment of Oesophageal Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function. 

Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated, patient-centric treatments that enhance quality of life.

Stay informed with LTR Pharma's latest announcements and market updates by visiting our Investor Centre.

SOURCE LTR Pharma Limited