Roxus® ED Nasal Spray Now Available in the U.S.: Peak Blood Levels in About 10 Minutes, Not an Hour

Available by prescription through telemedicine partner Mavrox.com/Roxus.

MINNEAPOLIS, Oct. 15, 2026 /PRNewswire/ -- LTR Pharma Limited (ASX: LTP), the Australian pharmaceutical company, today announced that Roxus® is now available to men across the U.S. Roxus is a prescription nasal spray for erectile dysfunction (ED) that delivers vardenafil, the same type of ED medicine as Viagra®, used in tablets for more than 20 years, through LTR's proprietary intranasal spray technology.

Roxus uses the same intranasal vardenafil formulation as SPONTAN®, LTR Pharma's nasal spray prescribed in Australia for the past two years. In clinical studies, including a peer-reviewed Phase 1 study, the spray reached peak blood levels in a median of about 10 minutes, compared with 45 to 60 minutes for vardenafil tablets.¹ Men 65 and older reached peak levels just as quickly, and the spray did it with a quarter of the tablet dose. Because it's absorbed through the nose rather than the stomach, it's designed to avoid the delays a heavy meal can cause with pills.

"For twenty years, ED treatment has meant taking a pill, waiting an hour, and hoping dinner doesn't get in the way. Roxus delivers vardenafil through the nose instead of the stomach, and in our clinical studies, our nasal spray reached peak blood levels in about ten minutes instead of an hour. That changes the experience for men and their partners, as it's effective within 5-10 minutes," said Lee Rodne, Executive Chairman, LTR Pharma.

"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," said Dr. Amy Pearlman, urologist and member of LTR Pharma's Scientific Advisory Board.

How to get Roxus

LTR Pharma has partnered with Shed, whose men's health telemedicine platform Mavrox brings Roxus to men nationwide.

To obtain a prescription, men complete a short online health assessment at Mavrox.com/Roxus. A licensed U.S. provider reviews it, and if Roxus is appropriate, Strive Pharmacy fills the prescription and ships it discreetly to their door. Men who prefer an in-person visit can ask their healthcare provider about Roxus. To learn more, visit Roxus.com.

IMPORTANT SAFETY INFORMATION

Do not use Roxus if you take nitrates for chest pain, recreational "poppers," or riociguat, or if you are allergic to vardenafil. Tell your provider about any heart, liver, or kidney problems, and all medicines you take. Seek emergency care for an erection lasting more than 4 hours or sudden vision or hearing loss. Common side effects include headache, flushing, runny or stuffy nose, indigestion, and temporary nasal discomfort.

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. Results may vary. Available by prescription only, when a licensed provider determines it is appropriate.

About LTR Pharma: LTR Pharma Limited (ASX: LTP) is an Australian commercial-stage pharmaceutical company that develops fast-acting intranasal medicines using its proprietary nasal spray technology. Its lead products, SPONTAN® (Australia) and Roxus® (U.S.), are nasal sprays for the treatment of erectile dysfunction. SPONTAN is progressing through the U.S. FDA 505(b)(2) pathway toward a planned Phase III study. ltrpharma.com

About Mavrox: Mavrox, operated by Shed, is a U.S. men's health telemedicine platform connecting men with licensed providers and personalized treatment. Mavrox.com

Reference

¹ Based on pharmacokinetic studies of SPONTAN®, LTR Pharma's intranasal vardenafil formulation, and published prescribing information for oral PDE5 inhibitors. No head-to-head study has compared Roxus with other ED treatments.

Viagra is a registered trademark of Pfizer Inc.

Media Contact: Fergus Linskey, Levo Health, [email protected]

SOURCE LTR Pharma