Spedra

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Spedra on Prescriptsy

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Spedra is the brand name for avanafil, a second-generation phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED) in adult men.

Avanafil was developed to address the limitations of earlier PDE5 inhibitors, offering a faster onset of action and greater selectivity for the PDE5 enzyme.

Spedra can begin working in as little as 15 minutes, making it the fastest-acting oral ED treatment available in the United Kingdom.

It is available in 50 mg, 100 mg, and 200 mg film-coated tablets and is classified as a prescription-only medicine (POM), manufactured by Menarini.

This page provides a detailed clinical guide to Spedra, covering how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.

Erectile dysfunction affects an estimated 4.3 million men in the UK and becomes increasingly common with age, affecting approximately 40% of men at 40 and close to 70% by age 70.

It is defined as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual activity.

ED has a significant impact on quality of life, self-confidence, and intimate relationships.

It is also recognised as an important early marker for cardiovascular disease, as both conditions share common underlying risk factors including hypertension, diabetes, hyperlipidaemia, obesity, and smoking.

The availability of effective oral treatments has transformed the management of ED, and Spedra represents the newest addition to the PDE5 inhibitor class in the UK market.

Important safety information about Spedra

Before reading further, please note these essential safety points.

• Spedra must never be taken with nitrate medicines (such as GTN spray or isosorbide mononitrate) or recreational nitrites ("poppers"), as the combination causes a dangerous drop in blood pressure.
• Spedra must not be used with certain antifungal or antiviral medicines (potent CYP3A4 inhibitors).
• If you experience an erection lasting more than 4 hours, seek immediate medical attention at A&E or call 999.
• Do not exceed one dose (maximum 200 mg) in any 24-hour period.
• Spedra does not protect against sexually transmitted infections or pregnancy.

Understanding erectile dysfunction

An erection is a haemodynamic event that requires the coordinated interaction of neural, vascular, and hormonal systems.

During sexual arousal, parasympathetic nerve fibres release nitric oxide (NO) from non-adrenergic, non-cholinergic (NANC) nerve terminals in the corpus cavernosum.

Endothelial cells lining the sinusoidal spaces also release NO.

Nitric oxide diffuses into adjacent smooth muscle cells and activates soluble guanylate cyclase, which catalyses the conversion of guanosine triphosphate (GTP) to cyclic guanosine monophosphate (cGMP).

Rising cGMP levels activate protein kinase G, which phosphorylates multiple targets to reduce intracellular calcium and promote smooth muscle relaxation.

The trabecular smooth muscle and helicine arteries relax, allowing arterial blood to fill the sinusoidal spaces of the corpora cavernosa under pressure.

As the corpora expand, the subtunical venules are compressed against the rigid tunica albuginea, restricting venous outflow and producing rigidity (the veno-occlusive mechanism).

ED occurs when any part of this process is disrupted. Vascular disease, particularly atherosclerosis of the pudendal and penile arteries, is the most common organic cause.

Endothelial dysfunction, which impairs NO release, is present in conditions such as diabetes, hypertension, and hyperlipidaemia.

Neurogenic causes include diabetic neuropathy, multiple sclerosis, spinal cord injury, and damage to the cavernous nerves during pelvic surgery (radical prostatectomy, colorectal surgery).

Hormonal deficiency (low testosterone) reduces libido and may impair the erectile response.

Psychological factors, including performance anxiety, depression, stress, and relationship difficulties, are common contributors, particularly in younger men.

Most cases of ED in men over 40 involve a combination of organic and psychogenic factors.

How Spedra works

Avanafil is a highly selective, potent inhibitor of PDE5.

Like other PDE5 inhibitors, it works by preventing the breakdown of cGMP in the corpus cavernosum, thereby prolonging and amplifying the smooth muscle relaxation initiated by nitric oxide release during sexual arousal.

This results in enhanced arterial inflow, improved sinusoidal filling, and a firmer, more sustained erection.

Avanafil does not produce an erection without sexual stimulation; the NO/cGMP pathway must first be activated by physical or psychological arousal.

What distinguishes avanafil from earlier PDE5 inhibitors is its pharmacokinetic and selectivity profile.

Avanafil is rapidly absorbed after oral administration, reaching peak plasma concentrations (Tmax) in approximately 30 to 45 minutes, with clinical effects observed in some men within 15 minutes.

This rapid onset is faster than any other available PDE5 inhibitor.

The terminal elimination half-life is approximately 6 to 17 hours, providing a duration of action of approximately 6 hours.

Avanafil demonstrates exceptional selectivity for PDE5.

It has over 100-fold greater selectivity for PDE5 compared with PDE6 (the retinal isoenzyme responsible for visual side effects with sildenafil), over 1,000-fold selectivity over PDE1, and over 10,000-fold selectivity over PDE3 (cardiac) and PDE4 (pulmonary).

This high selectivity translates into a lower incidence of off-target side effects such as visual disturbances (blue-tinged vision), which are uncommon with Spedra compared with sildenafil.

Clinical evidence for Spedra

Avanafil has been evaluated in multiple randomised, double-blind, placebo-controlled trials involving over 2,500 men with ED.

In a pivotal phase III trial, 100 mg and 200 mg doses of avanafil demonstrated statistically significant improvements in the International Index of Erectile Function (IIEF) erectile function domain score compared with placebo.

Successful vaginal penetration (SEP2) was achieved in 64% of attempts with 100 mg and 67% with 200 mg, compared with 42% with placebo.

Successful intercourse completion (SEP3) was achieved in 57% with 100 mg and 57% with 200 mg, compared with 27% with placebo.

A key differentiating trial evaluated the efficacy of avanafil within 15 minutes of dosing.

In this study, men who attempted intercourse 15 minutes after taking 200 mg avanafil achieved successful penetration in approximately 66% of attempts, compared with 48% for placebo.

This rapid onset has been replicated in other studies and is a unique clinical advantage of Spedra.

Avanafil has also shown efficacy in difficult-to-treat populations, including men with diabetes and those who have undergone bilateral nerve-sparing radical prostatectomy. Long-term extension studies have confirmed sustained efficacy and safety over 52 weeks of use.

Spedra compared with other PDE5 inhibitors

Four PDE5 inhibitors are available for ED in the UK: sildenafil, tadalafil, vardenafil, and avanafil (Spedra). All work through the same fundamental mechanism but have distinct pharmacokinetic profiles.

Sildenafil (Viagra) has an onset of 30 to 60 minutes and a duration of 4 to 6 hours.

Tadalafil (Cialis) has the longest duration at up to 36 hours and is available as a daily low-dose option. Vardenafil (Levitra) has a similar profile to sildenafil.

Spedra has the fastest onset (15 minutes in some men) and a moderate duration of approximately 6 hours.

No large head-to-head trial has compared all four PDE5 inhibitors directly. Choice is guided by patient preference and lifestyle.

Men who value spontaneity and do not want to plan ahead may prefer tadalafil. Men who want a rapid onset for on-demand use may prefer Spedra.

Sildenafil and its generics remain the most cost-effective option and are typically recommended as first-line treatment.

Spedra may be preferred for men who experience visual side effects with sildenafil, given its higher PDE5 selectivity, or for those who want the fastest possible onset.

Dosage and administration

Take one Spedra tablet approximately 15 to 30 minutes before planned sexual activity. The recommended starting dose is 100 mg.

Depending on efficacy and tolerability, your prescriber may adjust the dose to 50 mg or 200 mg. Do not take more than one dose in any 24-hour period.

Spedra can be taken with or without food. Absorption is not significantly affected by meals, including those with high fat content, which is an advantage over sildenafil. Swallow the tablet whole with water.

The effects of Spedra last approximately 6 hours, during which an erection can be achieved with sexual stimulation. This does not mean a continuous erection but rather an enhanced ability to respond to arousal during this window.

Side effects of Spedra

Common side effects

Headache is the most frequently reported side effect (approximately 10% of users). Flushing occurs in 4% to 5% and is milder than with some other PDE5 inhibitors.

Nasal congestion affects approximately 2% to 3% of users. Back pain has been reported.

These side effects are caused by PDE5 inhibition and vasodilation and are generally mild and self-limiting.

Uncommon side effects

Dizziness, dyspepsia, and nausea have been reported in a small percentage of users. Visual disturbances (blue-tinged vision) are very uncommon with Spedra due to its low activity against PDE6. Palpitations are rare.

Rare and serious side effects

Priapism is a medical emergency. If an erection persists for more than 4 hours, seek immediate medical attention at A&E or call 999.

NAION (sudden painless vision loss in one eye) and sudden sensorineural hearing loss have been reported very rarely with PDE5 inhibitors as a class.

Stop taking Spedra and seek urgent medical help if either occurs.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk.

Warnings and precautions

Absolute contraindications

Spedra must never be taken with organic nitrates or recreational nitrites. The combination causes severe, uncontrollable hypotension. Potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, telithromycin, nefazodone) are also contraindicated with Spedra. Riociguat is contraindicated with all PDE5 inhibitors.

Cardiovascular considerations

Men with cardiovascular conditions where sexual activity is inadvisable should not take Spedra.

These include recent myocardial infarction (within 6 months), unstable angina, severe heart failure, uncontrolled arrhythmias, and recent stroke.

Men with stable cardiovascular disease who can undertake moderate physical exercise (brisk walking, two flights of stairs without symptoms) can generally use Spedra safely.

Drug interactions

Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem, verapamil, aprepitant) limit the maximum dose of Spedra to 100 mg within any 48-hour period.

Alpha-blockers may cause additive hypotension; patients already on stable alpha-blocker therapy can start Spedra at 100 mg.

Do not combine Spedra with other PDE5 inhibitors or other ED treatments.

Special populations

Men with anatomical penile deformity or conditions predisposing to priapism should use Spedra with caution. Those with hereditary retinal disorders or previous NAION should avoid PDE5 inhibitors. Excessive alcohol impairs erections and increases the risk of hypotensive side effects.

Lifestyle measures alongside Spedra

Combining Spedra with healthy lifestyle changes improves outcomes.

Regular cardiovascular exercise (at least 150 minutes per week of moderate activity), weight management, smoking cessation, and moderation of alcohol intake (no more than 14 units per week as per NHS guidance) all support erectile function.

Addressing psychological factors through psychosexual therapy or cognitive behavioural therapy can be particularly beneficial.

A healthy diet rich in fruit, vegetables, whole grains, and oily fish supports vascular health.

Treating underlying conditions such as diabetes, hypertension, and hyperlipidaemia also improves erectile function over time.

Erectile dysfunction as a cardiovascular marker

ED and cardiovascular disease share common pathophysiology, principally endothelial dysfunction and atherosclerosis. Studies have shown that ED may precede symptomatic coronary artery disease by 3 to 5 years.

Men presenting with ED should undergo cardiovascular risk assessment, including blood pressure measurement, fasting lipid profile, glucose or HbA1c, and assessment of smoking status and BMI.

NICE and the European Association of Urology both recommend this assessment as part of the ED consultation. Treating cardiovascular risk factors benefits both heart health and erectile function.

How to get Spedra in the UK

Spedra is available on NHS prescription from your GP or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

As a branded medicine, your GP may first recommend trying generic sildenafil or tadalafil, which are typically less expensive.

If these are not suitable or tolerated, Spedra can be prescribed.

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Spedra can also be obtained via private prescription from authorised online prescribers or clinics.

Sources

• Spedra, Summary of Product Characteristics (EMC)
• Avanafil, British National Formulary (BNF)
• Erectile dysfunction, NICE CKS
• Avanafil (Spedra), NHS
• MHRA Yellow Card Scheme