PRODUCT ANNOUNCEMENT

Hezkue® (sildenafil) 12.5mg/actuation, oromucosal spray, suspension

Reigniting management of erectile dysfunction

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.

Hezkue® (sildenafil) 12.5mg/actuation, oromucosal spray, suspension

COMPANY
Aspargo Labs Italia S.r.l

LEGAL CATEGORY
POM

ACTIVE INGREDIENT
Sildenafil (as citrate)

PRESENTATION
Oromucosal spray: 12.5mg per 0.5ml actuation, 30ml=£41.99.

INDICATION
Adult 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 effective, sexual stimulation is required.

DOSAGE
Adult: Recommended dose is 50mg (4 actuations) orally approx 1 hr before sexual activity. This may be decreased to 25mg (2 actuations) or increased to 100mg (8 actuations) as needed; max 100mg once daily.

Children: Under 18 years, not recommended.

CONTRAINDICATIONS
Hypersensitivity 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. See also Interactions below.

WARNINGS
Cardiovascular 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). Active peptic ulcer, bleeding disorders. Advise patients to report immediately any sudden changes in vision (and to discontinue treatment if occur) or erection lasting >4 hrs.

INTERACTIONS
Nitrates (contraindicated), amyl nitrite (contraindicated), other erectile dysfunction agents (contraindicated), ritonavir, other CYP3A4 inhibitors (eg, ketoconazole, erythromycin, cimetidine, saquinavir) or inducers (eg, rifampicin), α-blockers, nicorandil (contraindicated), riociguat (contraindicated), sacubitril/valsartan, grapefruit juice.

ADVERSE EFFECTS
Very common: headache.

Common: dizziness, visual colour distortions, visual disturbance, vision blurred, flushing, nasal congestion, nausea, dyspepsia.

KEY POINTS


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. In addition, the bioavailability (area under the curve [AUC] ratio) 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 oromucosal spray delivers the same efficacious doses as sildenafil tablets, with no new safety concerns or oral mucosal safety issues.2,3

In a cross-sectional study, 81 sexually active men with new-onset sexual dysfunction, were treated with sildenafil 50mg orodispersible film for 12 weeks then, after washout, with sildenafil 50mg oral suspension for 12 weeks. At follow-up after each 12-week period, patients completed the International Index of Erectile Function (IIEF), the Patient Global Impression of Improvement (PGI-I) and the Psychological and Interpersonal Relationship Scales-Short Form (PAIRS-SF) questionnaires. Sildenafil oral suspension demonstrated higher satisfaction and spontaneity scores and better overall patient satisfaction when compared with sildenafil orodispersible film (all p<0.01).5

A nationwide Spanish study of 30 urologists and andrologists, aggregating information from the last 6 patients who attended their practice who were treated with Hezkue®, indicated that most patients were highly satisfied with the product due to its formulation, opportunities for flexible dosing, convenience and discreetness.6

REFERENCES

  1. Aspargo Labs, data on file. HEZ002.
  2. Hezkue. Summary of Product Characteristics. Accessed November 2025.
  3. Kaplan SA, et al. Pharmacokinetic parameters of a novel sildenafil oral liquid suspension administered to healthy adult men under fasted conditions. Int J Sci Res 2024; 13: 759-64.
  4. Aspargo Labs, data on file. HEZ001.
  5. Boeri L, et al. Effectiveness and patient satisfaction with the new sildenafil oral suspension formulation compared to sildenafil oro-dispersible film: a real-life study. Int J Impot Res 2025:1-6.
  6. Ibarra FP, et al. Study UNICO: perception of urologists and andrologists, in Spain, about the use of sildenafil oral suspension in patients with erectile dysfunction. Arch Esp Urol 2023; 76: 139-44.

For more information contact Aspargo UK, 2 Cabot House, Compass Point Business Park, St Ives, United Kingdom, PE27 5JL.
Legal information, Aspargo Labs Italia S.r.l., Via Po, 102, 00198 Rome – Italy.

For more information contact Aspargo UK, 2 Cabot House, Compass Point Business Park, St Ives, United Kingdom, PE27 5JL.
Legal information, Aspargo Labs Italia S.r.l., Via Po, 102, 00198 Rome – Italy.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Aspargo Labs by emailing safety@aspargolabs.com or by calling 01480 465755

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Aspargo Labs by emailing safety@aspargolabs.com or by calling 01480 465755

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