Spray
Use once per nostril as directed.
World's First Intranasal Delivery of a Proven PDE-5 Inhibitor for Erectile Dysfunction
Ready when they are.
Roxus® At-a-Glance
Intranasal Delivery of a Proven PDE-5 Inhibitor for Erectile Dysfunction
Clinical Indication
Erectile Dysfunction (ED)
Active Ingredient
Vardenafil HCL
Transmucosal Absorption Benefits
- Rapid onset in as little as 10 minutes
- Bypasses hepatic first-pass metabolism
- Suitable for patients with dysphagia
Access Pathway
Available via 503A compounding pharmacy
Delivery & Dosing
- RDD: 5mg (2 sprays, one per nostril)
- Dose delivered from a single spray = 2.5mg per 130uL
Patient Eligibility
Deliver and Dosing
- ED not effectively treated by standard therapy
- Desire faster onset/greater spontaneity
- Difficulty with oral medications
- Clinical evidence suggests intranasal therapy could improve outcomes
Roxus® Key Clinical Benefits
Rapid Onset of Action¹
Less than 10-minute onset enables greater spontaneity in intimate situations.
Consistent Therapeutic Effects¹
Less variability in pharmacokinetic parameters provides more predictable patient responses.
Proven & Well-tolerated¹,³
Comparable efficacy to oral PDE-5 inhibitors with a similar systemic adverse event profile.
Personalized Medication
Designed to address patient needs related to onset, reliability, and tolerability.
Lower Dose Required¹,³
Comparable plasma concentrations with 5mg intranasal versus 10mg oral, reducing overall drug exposure.
References:
1. Wang, J et al. “Pharmacokinetics Comparison of Vardenafil as Administered by an Intranasal Spray Formulation vs a 10-mg Oral Tablet.” The Journal of Sexual Medicine 00, no. 00 (2023) 1–6. https://doi.org/10.1093/jsxmed/qdad056.
2. E. Chung et. al. 2025, Pharmacokinetics of an oral versus intranasal delivered formulation of the phosphodiesterase type 5 inhibitor vardenafil in healthy men – a phase 1, randomized open label, single dose, two period, two treatment, cross-over study. European Journal of Pharmaceutical Sciences 213 (2025) 107226.
3. Data on file.
Intranasal Drug Delivery vs. Oral¹
Absorption
Drug Delivery
Clinical Effect
Food & Drink
Dosing
Absorption
Rapid absorption into systemic circulation
Drug Delivery
Bypasses hepatic first-pass metabolism
Clinical Effect
Rapid clinical effect (<10 minutes)
Food & Drink
Not affected by food or beverages
Dosing
Lower doses required to achieve a similar clincal effect
Absorption
Absorption through the gut mucosa
Drug Delivery
Undergoes hepatic first-pass metabolism (90-95% drug removed)
Clinical Effect
Delayed clinical effect (30-60 minutes)
Food & Drink
Delayed or reduced absorption from food or beverages
Dosing
Higher doses required
References:
1. Wolfe, T.R. (2022). Not Just a Single Squirt: Understanding Nasal Drug Delivery. EMS Airway. Available at: https://emsairway.com/2022/04/01/understanding-nasal-drug-delivery/.
How it Works
From desire to action in as little as five minutes*
Three simple steps from spray to confidence.
Contains a clinically proven PDE5 inhibitor via nasal delivery.
This medication is compounded and is not FDA-approved. It is prescribed by a licensed clinician based on individual patient needs.
Indication:
ROXUS® (vardenafil HCL nasal spray) is indicated for the treatment of erectile dysfunction (ED).
Contraindications
Use of vardenafil, including ROXUS, is contraindicated in patients taking organic nitrates or nitric oxide donors.
Warnings and Precautions
The warnings and precautions for vardenafil tablets apply equally to ROXUS nasal spray:
- Priapism: Erections lasting over 4 hours require immediate medical intervention.
- Sudden Hearing Loss: Discontinue use and seek immediate medical attention if sudden hearing loss occurs.
- Effects on the Eye: Discontinue use and seek immediate medical attention if sudden vision loss occurs, potentially indicating NAION.
- QT Prolongation: Avoid use in patients with QT prolongation or those taking class IA or III antiarrhythmics.
- Hepatic Impairment: Not recommended for patients with severe hepatic impairment. Reduced dose advised for moderate impairment.
- Renal Impairment: Not recommended for patients on dialysis; no data available for renal impairment use.
- Pregnancy and Lactation: Classified as Pregnancy Category B. Not indicated for use in women. No data on excretion in breast milk.
- Paediatric Use: Not indicated for use in patients under 18 years.
- Management of Overdose: There is no specific antidote for vardenafil overdose. Management should involve standard supportive care. Renal dialysis is unlikely to be effective due to high plasma protein binding.
Drug Interactions:
- Nitrates: Concurrent use with organic nitrates is contraindicated due to severe hypotension risk.
- Alpha-Blockers: Use with caution due to potential for significant hypotension.
- Antihypertensives: May enhance blood pressure-lowering effects.
- CYP3A4 Inhibitors: Potent inhibitors (e.g., ketoconazole, indinavir, ritonavir) and moderate inhibitors (e.g., erythromycin, azithromycin) increase vardenafil levels and prolong its half-life. Dosage adjustments or avoidance are recommended.
- Antiarrhythmics: Patients on class IA or III antiarrhythmics should avoid vardenafil.
Adverse Effects:
Common side effects include headache, flushing, rhinitis, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, and nausea. Rare cases of vision loss (NAION), sudden hearing loss, and prolonged erections (priapism) have been reported.
Dosage:
ROXUS is administered via a nasal spray device, delivering 2.5 mg of vardenafil hydrochloride per spray. The recommended dosage is 2 sprays (one per nostril). ROXUS is a prescription medicine.
IFU date: 22 May 2024. Edition 1.1 Roxus® is a registered trade mark of LTR Pharma Ltd.