LTR Pharma Brings Roxus® Intranasal Vardenafil to U.S. Prescribers: Peak Plasma Levels in a Median of 10 Minutes

On-demand nasal spray now available for patient-specific prescribing through Strive Pharmacy, a Section 503A compounding pharmacy serving patients nationwide

MINNEAPOLIS, Oct. 8, 2026 /PRNewswire/ -- LTR Pharma Limited (ASX: LTP), an Australian commercial-stage pharmaceutical company focused on men's health, today announced U.S. availability of Roxus®, a compounded intranasal formulation of vardenafil hydrochloride for erectile dysfunction (ED). Roxus is dispensed exclusively through Strive Pharmacy under Section 503A of the Federal Food, Drug, and Cosmetic Act. It offers urologists, men's health specialists, and primary care clinicians a rapid-onset, on-demand alternative to oral PDE5 inhibitors.

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An estimated 30 to 35 percent of men do not respond adequately to oral PDE5 inhibitors,¹ and oral tablets ask every patient to plan intimacy around absorption time and meals. Roxus takes a different approach to both: a different route of delivery rather than a different molecule.

Roxus is the U.S. compounded form of SPONTAN®, LTR Pharma's proprietary intranasal vardenafil formulation, which is progressing through the U.S. FDA 505(b)(2) development pathway toward a planned Phase III study. The following clinical data were generated with SPONTAN.

Clinical Evidence

In a Phase 1 randomized, open-label, two-period crossover study, published in the peer-reviewed European Journal of Pharmaceutical Sciences, 19 healthy men were randomized to intranasal vardenafil (5 mg) and oral vardenafil tablets (10 mg); 18 completed both periods.² Intranasal delivery reached peak plasma concentration in a median of approximately 10 minutes (range 9–15 minutes). The oral tablet took approximately 45 minutes (range 30–150 minutes). Dose-normalized Cmax was higher with the intranasal formulation, and half-life was comparable (4.15 vs. 4.23 hours). Adverse events were similar for the two formulations, with more upper-respiratory irritation following intranasal administration.

Final results from LTR Pharma's Phase II pharmacokinetic study, reported in October 2026, were consistent with Phase 1. In 27 healthy men, including 14 aged 65 and older, intranasal vardenafil (5 mg) reached peak plasma concentration in a median of 10 minutes (range 10–15 minutes), versus 60 minutes (range 30–186 minutes) for the 20 mg oral tablet: six-fold faster, at one quarter of the oral dose (p<0.0001). The pharmacokinetic profile was maintained in subjects aged 65 and older. No serious or severe adverse events and no discontinuations were reported.

Real-World Experience

In a retrospective cohort of 147 Australian men treated with SPONTAN (mean age 65.6 years; 62 percent with a history of prostate cancer), 68 percent reported improved hardness or penetration. Among men who sought a faster-acting option, 93 percent responded; among men with an inadequate response to oral therapy, 57 percent responded; and among men following prostatectomy, 64 percent responded. The study was single-center and patient-reported, and is undergoing peer review.³

"Oral PDE5 inhibitors changed ED care, but they still ask patients to plan intimacy around absorption, food, and timing. Consistent peak levels in about ten minutes, including in men over 65, give clinicians and patients a genuinely different option," said Professor Geoffrey Strange, Chief Medical Officer, LTR Pharma.

Ideal Patient Profile

Dr. Andrew Sun, Scientific Advisory Board, LTR Pharma said, "In a high-volume men's health practice, the same issues come up again and again: timing, predictability and side effects. ROXUS offers the rapid onset men want."

Roxus may be well suited to adult men with ED who are appropriate candidates for PDE5 inhibitor therapy and who:

• value spontaneity and dislike planning 30 minutes to 2 hours ahead
• report inconsistent response to oral agents related to meals, particularly high-fat meals
• experience GI discomfort with oral therapy or have difficulty swallowing tablets
• are older patients seeking predictable absorption (the PK profile was maintained in patients 65 and older)

Patients should have no significant nasal pathology that could impair intranasal absorption.

Dosing and Administration

LTR Pharma's clinical studies evaluated 5 mg vardenafil delivered intranasally; the compounded strength is specified by the prescriber. Patients administer the dose approximately 10–15 minutes before sexual activity. Maximum dosing frequency is once per 24 hours. Sexual stimulation is required for efficacy.

Safety Information

Roxus contains vardenafil and carries the established safety considerations of the PDE5 inhibitor class.

• Contraindications: Do not prescribe to patients using nitrates in any form or guanylate cyclase stimulators such as riociguat, or to patients with known hypersensitivity to vardenafil.
• Drug interactions: Use caution, and adjust or avoid use, with alpha-blockers and with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, and other HIV protease inhibitors.
• Cardiac and hepatic caution: Use caution in patients with congenital or acquired QT prolongation, in patients with hepatic impairment, and in patients for whom sexual activity is inadvisable due to cardiovascular status.
• Patient counseling: Advise patients to seek emergency care for erections lasting more than 4 hours, and to stop use and seek care for sudden vision or hearing loss.
• Common adverse events: Headache, flushing, nasal congestion or rhinitis, and dyspepsia. Transient nasal irritation may occur with intranasal administration.

Important Regulatory Notice: 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 judgment when determining appropriateness for individual patients. The clinical data referenced above were generated with LTR Pharma's intranasal vardenafil formulation (SPONTAN®/SDS-089).

¹ McMahon CN, Smith CJ, Shabsigh R. Treating erectile dysfunction when PDE5 inhibitors fail. BMJ 2006;332:589–592.

² Chung E, Argent C, Strange G. Pharmacokinetics of an oral versus intranasal delivered formulation of the phosphodiesterase type 5 inhibitor vardenafil in healthy men. Eur J Pharm Sci 2025;213:107226.

³ LTR Pharma ASX announcement, 11 August 2026. Retrospective, single-center cohort; patient-reported outcomes; manuscript under peer review.

About LTR Pharma:
LTR Pharma Limited (ASX: LTP) is an Australian commercial-stage pharmaceutical company delivering innovative therapies to address significant unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has commercialized its rapid-acting treatment technology in Australia and is expanding access while advancing regulatory pathways in the U.S. and other key markets. Its lead products, SPONTAN® and Roxus®, are fast-acting intranasal sprays for the treatment of erectile dysfunction. SPONTAN is available in Australia under the Therapeutic Goods Administration's Special Access Scheme and is progressing through the U.S. FDA 505(b)(2) pathway toward a planned Phase III study; Roxus is available in the U.S. through the Section 503A personalized-medicine pathway. The Company is also advancing OROFLOW®, an intranasal spray in development for esophageal motility disorders. https://ltrpharma.com/ | https://roxus.com/ 

Media Contact: Fergus Linskey, Levo Health, [email protected], +1 (585) 703-9535
Investor Relations: Peter McLennan, Chief Operating Officer, LTR Pharma, [email protected]

SOURCE LTR Pharma