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15th Oct, 2026 12:00 AM

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New Nasal Spray for Erectile Dysfunction Now Available in US

Roxus (LTR Pharma Limited), a new nasal spray for erectile dysfunction, is now available in the United States, according to a press release from Mavrox, a men's health telemedicine platform.

The spray contains vardenafil, a drug used to treat erectile dysfunction, and uses the same nasal formulation as Spontan, LTR Pharma's nasal spray available by prescription in Australia for the past 2 years, the release said.

A peer-reviewed phase 1 study found that nasal vardenafil reached peak blood levels in a median of 10 minutes, compared with 45-60 minutes for tablets. Men aged 65 or older reached peak levels just as quickly, and the spray achieved peak levels with one quarter of the tablet dose.

Roxus is available by prescription through Mavrox. Patients can complete an online health assessment at Mavrox.com/Roxus to be evaluated for a prescription or ask their healthcare provider about the treatment.

Article Key Points

Nasal vardenafil spray now available in US via prescription.
Phase 1: median Tmax 10 min vs 45–60 min tablets.
Men ≥65 y reached peak levels similarly fast.
Peak levels achieved with ~25% tablet dose.
Compounded; not FDA reviewed/approved for safety/effectiveness.

Dive Deeper

How does intranasal vardenafil compare with oral PDE5 inhibitors?

What phase 2 efficacy data exist for nasal vardenafil?

Which patients benefit most from rapid-onset PDE5 therapy?

Roxus is a compounded medication that has not been reviewed or approved by the FDA for safety or effectiveness, the release said.

SUGGESTED FOR YOU

Roxus should not be used with nitrates or riociguat, and it should not be used by by people allergic to vardenafil. Patients should tell their healthcare provider about any heart, liver, or kidney conditions and all medications they take.

Common side effects include headache, flushing, nasal congestion, runny nose, indigestion, and nasal discomfort. Patients should seek emergency medical care for an erection lasting more than 4 hours or sudden vision or hearing loss.

Dive Deeper

Commonly Asked by HCPs

Q: What are guideline-based first-line treatments for erectile dysfunction?

A: First-line erectile dysfunction management typically starts with identifying reversible contributors, addressing cardiometabolic risk factors, and using a PDE5 inhibitor when not contraindicated. Research usually focuses on treatment selection, expected efficacy, counseling on timing and sexual stimulation, and when to move beyond oral therapy if response is inadequate.

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Q: How should clinicians choose between oral, intraurethral, and injectable erectile dysfunction therapies?

A: Choice among oral, intraurethral, and injectable therapies usually depends on efficacy, onset, duration, tolerability, and patient preference. Oral PDE5 inhibitors remain common first-line therapy, while local or injectable options are generally considered when oral treatment is ineffective, not tolerated, or contraindicated.

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Q: What contraindications and drug interactions matter most with PDE5 inhibitors?

A: The most important safety issue with PDE5 inhibitors is coadministration with nitrates, and riociguat is also contraindicated. Clinicians also review alpha-blockers, hepatic or renal impairment, cardiovascular status, and other interacting medications before prescribing to reduce hypotension and other adverse events.

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Q: What adverse effects and safety issues should clinicians monitor with PDE5 inhibitors?

A: Common PDE5 inhibitor adverse effects include headache, flushing, dyspepsia, nasal congestion, and visual symptoms, with rare but serious events such as priapism or sudden vision or hearing loss. Ongoing safety review also includes dose adjustment considerations in hepatic or renal dysfunction and monitoring for tolerability over time.

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Q: How is erectile dysfunction managed in men with cardiovascular disease?

A: Erectile dysfunction in men with cardiovascular disease requires attention to overall vascular risk, exercise tolerance, and medication compatibility. Research commonly addresses when sexual activity is safe, how to coordinate with antihypertensive or antianginal therapy, and how ED can serve as a marker of underlying vascular disease.

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