Steven A. Kaplan, MD, shares initial data on sildenafil oral spray vs tablets

In addition, the bioavailability (area under the curve [AUC] ratio)

Storage Condition	Temperature Range	Protection Required	Shelf Life
Room Temperature	20-25°C	Keep away from heat and moisture	2 years
Refrigeration Recommended	2-8°C	Avoid freezing	N/A
Exposure to sunlight	No direct sunlight	Store in a dark place	N/A

was three times higher for the oromucosal spray than for the tablets 20 minutes after administration (646.92ng/ml/min versus 199.21ng/ml/min, p<0.01).3,4● Sildenafil

2. Sildenafil Oral Suspension Dosage and Administration

Results of a phase 1 study published in the International Journal of Science and Research, revealed the spray achieves absorption beginning at five minutes, which is twice as fast as traditional sildenafil tablets. Kaplan, the chief medical officer at Aspargo Labs, director of the Men’s Wellness Program at the Mount Sinai Health System and professor at the Icahn School of Medicine at Mount Sinai, reflected on the challenges of prescribing ED medications due to issues with convenience and food effects, which can reduce spontaneity and efficacy. Many patients, he explained, are unaware that taking these medications with food can reduce their effectiveness, leading to frustration and treatment failure. The goal, therefore, is to create a more convenient, rapid-acting ED medication without sildenafil citrate tablets 150 mg food interference. The introduction of a new delivery system shows promise in overcoming these challenges.

What side effects can happen with Silfin Oral Spray?

This faster absorption could reduce the necessary dosage and side effects while improving overall efficacy. The hope is that faster absorption will lead to quicker results, helping patients avoid more invasive treatments like penile injections or surgeries. The medication is currently in the testing phase, focusing on its food effects, absorption rate and overall efficacy. Kaplan and his team aim to receive US Food and Drug Administration (FDA) approval in the US by 2025. This innovation is not just about creating new drugs, he said, but also repurposing existing medications with better delivery methods to enhance patient outcomes.

What should I do if I miss a dose of sildenafil?

The integration of new technology, such as a discrete and convenient delivery device, is also seen as a major advancement in ED treatment. Overall, he emphasized that innovation in medical treatments continues to evolve, providing hope and better health outcomes for patients struggling with ED. The spray is a liquid suspension of sildenafil citrate administered orally via a spray pump. The German Federal Institute for Drugs and Medical Devices has granted regulatory approval to market Sildenafil oral spray (trade name, Hezkue) for erectile dysfunction (ED) in Germany. The spray was also recently approved for marketability in Ireland and the Netherlands, according to a news release from Aspargo Laboratories, the developer of the treatment.1 The German market is the largest in the EU, and the aggregate erectile dysfunction market for Germany, Ireland, and the Netherlands exceeds $175 million. oromucosal spray delivers the same efficacious doses as sildenafil tablets, with

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no new safety concerns or oral mucosal safety issues.2,3● In

13. Nonclinical Toxicology

“These product approvals reflect Aspargo’s commitment to quickly expand its global platform to the EU during 2023. The Marketing Authorizations are an important achievement. They validate Aspargo’s international regulatory strategy and sildenafil 25 mg tablets confirm that Aspargo meets the highest standards required to ensure the safe distribution of sildenafil spray,” said Michael Demurjian, Chairman and Chief Executive Officer of Aspargo. Hezkue 12.5mg per actuation, oral suspension was developed by the specialty pharmaceutical group Aspargo Laboratories Inc. in partnership with their commercialization consultant, Syneos Health.

12.2 Pharmacodynamics

The 2 groups held focus groups and conducted surveys with physicians, pharmacists, and patients throughout the development process. Aspargo uses a metered-dose pump so that it can deliver the precise, customized dose per push based on the needs of the patient. According to Aspargo, Sildenafil spray is also discreet, easy to carry, and allows patients to avoid crushing or splitting pills with the traditional tablet medications currently available for ED. Aspargo Laboratories is currently seeking FDA approval to market Sildenafil spray in the United States. Aspargo receives regulatory approval to market sildenafil spray in Germany, Ireland, and the Netherlands.

Rare but serious

Conventional treatments for erectile dysfunction (ED) require planning and may cause timing anxiety with delayed onset of action.1 Hezkue®, a sildenafil suspension, is the first phosphodiesterase type 5 (PDE-5) inhibitor suspension spray for ED that offers flexible dose adjustment based on individual patient needs.2 The below is a MIMS summary of the Hezkue® product characteristics. Please refer to the full Summary of Product Characteristics (SPC) before prescribing. INDICATIONAdult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Hezkue to be sildenafil oral jelly 100mg effective, sexual stimulation is required. DOSAGEAdult: Recommended dose is 50mg (4 actuations) orally approx 1 hr before sexual activity. a cross-sectional study, 81 sexually active men with new-onset sexual dysfunction,

• Sildenafil spray is approved in some regions for ED.
• It may provide a more convenient dosing method.
• Users should avoid driving until effects are known.
• The spray’s rapid absorption may enhance spontaneity.
• It is important to monitor blood pressure when using.
• Sildenafil spray should not be used with grapefruit juice.
• It’s essential to disclose all health conditions to the doctor.
• The spray formulation might reduce medication costs.
• It can be part of a healthy lifestyle for better results.
• Consistent application improves and prolongs effectiveness.
• Always consult healthcare providers before starting.

were treated with sildenafil 50mg orodispersible film for 12 weeks

• Sildenafil spray can enhance male sexual performance.
• It is often used when oral pills are not suitable.
• The spray allows for targeted delivery to the bloodstream.
• Rapid onset makes it suitable for spontaneous encounters.
• Use the spray exactly as directed by the healthcare professional.
• There is a risk of priapism with overuse.
• The spray may cause minor irritation at the application site.
• It is advisable to have medical supervision during use.
• The spray’s effectiveness depends on individual health.
• It is recommended to avoid alcohol for better results.
• Regular follow-up visits ensure safe use over time.

then, after washout, with sildenafil 50mg oral suspension for 12 weeks.

How to use Silfin Liquid

This may be decreased to 25mg (2 actuations) or increased to 100mg (8 actuations) as needed; max 100mg once daily. CONTRAINDICATIONSHypersensitivity to the active substance or excipients. Cardiac conditions where sexual activity is inadvisable, non-arteritic anterior ischaemic optic neuropathy, severe hepatic impairment, hypotension, recent stroke or MI, hereditary degenerative retinal disorders. WARNINGSCardiovascular disease, left ventricular outflow obstruction, severe autonomic dysfunction, severe renal impairment (CrCl <30ml/min), mild to moderate hepatic impairment. Abnormal penile anatomy or predisposition to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). At follow-up after each 12-week period, patients completed

Reigniting management of erectile dysfunction

Advise patients to report immediately any sudden changes in vision (and to discontinue treatment if occur) or erection lasting >4 hrs. Common: dizziness, visual colour distortions, visual disturbance, vision blurred, flushing, nasal congestion, nausea, dyspepsia. ● Hezkue® is the first PDE-5 inhibitor suspension spray for erectile dysfunction that offers flexible dose adjustment based on individual patient needs.2 Hezkue® uses a suspension technology that provides fast absorption starting within 5 minutes.2–4● A prospective open-label, single-centre, two-way crossover study evaluated the pharmacokinetics, safety and tolerability of 100mg of sildenafil oromucosal spray (8 pumps) and 100mg sildenafil (Viagra®) tablets in 52 fasted healthy male volunteers.3 ● Initial absorption of sildenafil oromucosal spray was observed within 5 minutes of administration, while sildenafil tablets showed no absorption at that time. The absorption rate (Cmax/time of the maximum plasma concentration [Tmax]) of the oromucosal spray was statistically significantly faster than sildenafil tablets at 5–20 minutes and twice as fast as that of sildenafil tablets 20 minutes after administration (16.00ng/ml/min versus 7.84ng/ml/min, p<0.01). The rate of absorption was not significantly different overall between the oromucosal spray and tablets. the International Index of Erectile Function (IIEF), the

Parameter	Value	Notes
Onset of Action	15-30 minutes	Faster than oral tablets
Peak Plasma Levels	30-45 minutes	Rapid absorption
Duration of Effect	Up to 4 hours	Similar to or slightly shorter than oral form

Patient Global Impression of Improvement (PGI-I) and the

How Does Spray for Erectile Dysfunction Work?

Cialis Together – An over-the-counter version of Cialis that contains 10mg of tadalafil, which improves erections in 81% of people and can last for up to 36 hours. Eroxon gel – A topical gel that’s applied directly to the head of the penis to stimulate the nerve endings, resulting in an erection. It does not contain an active ingredient, so it has few side effects and helps 60% of people get an erection within 10 minutes. Penis pump – A manually operated device that can increase blood flow to the penis to help you get and maintain an erection. A penis pump does not contain any medication, so it may be a suitable alternative if you would prefer not to take drugs to treat erectile dysfunction.

Hezkue FAQs

Although drinking a small amount of alcohol is generally considered safe while taking Hezkue, it is not recommended because it can reduce its effectiveness and make erectile dysfunction worse. Alcohol may also enhance the side effects of Hezkue spray, such as feeling sick or lightheadedness. No, you must not use Hezkue with any other erectile dysfunction medications, as this can increase the chance of side effects. If you do not think that Hezkue is working for you, contact your doctor for advice, as they may recommend an alternative ED treatment. There are no special storage instructions for Hezkue, but it must be kept out of sight and reach of children and pets.

Hezkue warnings

Do not use the Hezkue spray after the expiry date. Once you have opened the bottle, it must be used within 10 months. Hezkue has a mint flavour which helps to cover up the naturally bitter taste of sildenafil. Comparison of clinical trials with sildenafil, vardenafil and tadalafil in erectile dysfunction, PubMed [accessed 16 August 2025] Efficacy and Treatment Satisfaction with On-Demand Tadalafil (Cialis®) in Men with Erectile Dysfunction, European Urology [accessed 16 August 2025] Efficacy of Sildenafil oral spray for the treatment of erectile dysfunction in patients with type 2 diabetes mellitus and prediabetes, PubMed [accessed 15 August 2025] Hezkue Sildenafil Suspension, Aspargo Labs [accessed 15 August 2025] PD52-07 EFFICACY AND SAFETY OF MED3000, A NOVEL TOPICAL THERAPY FOR THE TREATMENT OF ERECTILE DYSFUNCTION, The Journal of Urology [accessed 16 August 2025] Sildenafil 50 mg film-coated tablets, emc [accessed 15 August 2025] Spedra 200 mg tablets, emc [accessed 16 August 2025] Who can and cannot take sildenafil, NHS [accessed 16 August 2025] A new sildenafil oral spray, ASP-001, currently under investigation, shows promise in treating erectile dysfunction. In an interview with The Educated Patient, Steven Kaplan, MD, discussed an investigative sildenafil oral spray, ASP-001, that is currently in development for the treatment of erectile dysfunction (ED). Psychological and Interpersonal Relationship Scales-Short Form (PAIRS-SF) questionnaires.

Country/Region	Approval Status	Notes
United States	Not FDA approved for spray form	Available through clinical trials
European Union	Under investigation	Not yet commercialized
Australia	Restricted to research purposes	Not available commercially
Asia (e.g., India)	Limited approval for sildenafil formulations	Regulatory pathway ongoing