Spedra is a new medicine for the treatment of erectile dysfunction in adult men.
Erectile dysfunction – the inability to attain and/or maintain a penile erection sufficient for satisfactory sexual performance – affects approximately 20–40% of men at 40 years of age and 70% at 70 years.
What is Spedra?
Spedra (whose active ingredient is avanafil) joins the group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which includes Viagra (sildenafil), Cialis (tardalafil) and Levitra (vardenafil). These medicines increase the concentration of a naturally-occurring substance that has a blood vessel-relaxing effect, thus allowing blood to flow into the penis and producing an erection.
Is Spedra effective?
Meaningful improvements in erectile function are seen across 50–200 mg doses of Spedra. Studies have shown that men taking Spedra get erections sufficient to achieve vaginal penetration in up to about 80% of attempts. Erections enabling vaginal penetration were reported on over 20% more occasions for men taking Spedra than for men taking a placebo (a pill that does not contain the active ingredient). Additionally, successful intercourse was also reported to occur on 20–30% more occasions for men taking Spedra than for men taking a placebo. Spedra’s effect has been shown to last for longer than 6 hours.
You can find more information on clinical trials here - http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002581/smops/Positive/human_smop_000499.jsp&mid=WC0b01ac058001d127
Spedra side effects
Side effects seen with Spedra were generally mild to moderate in severity, and disappeared when the treatment effect wore off. Spedra’s most common side effects are headache, flushing, and nasal and sinus congestion. As a general precaution, you should ask your doctor if the condition of your health permits you to take this medicine.
What is different about Spedra?
Compared with other available PDE5 inhibitors for erectile dysfunction, Spedra is a more potent medicine that works very quickly. An erection usually occurs between 20 and 40 minutes after taking the medicine (compared to approximately 60 minutes with sildenafil), and successful sexual (vaginal) intercourse is reported to occur after just 15 minutes of taking the medicine. Spedra’s fast onset of action may therefore allow for more spontaneous sex between men with erectile dysfunction and women.
Compared with other PDF-5 medicines for erectile dysfunction, men taking Spedra are less likely to experience visual disturbances (such as blue vision) than men using sildenafil or
myalgia (muscle pain) than men using tadalafil. Spedra is less likely to cause low blood pressure (hypotension) than sildenafil. Additionally, the enhancement of hypotension caused by nitrate-containing medicines, such as nitroglycerin, was significantly less pronounced by Spedra than by sildenafil. Spedra might therefore be particularly suitable for men with erectile dysfunction and cardiovascular disease who are on nitrates.
Can I get Spedra? – UPDATE
Spedra has been approved by the Food and Drug Administration (FDA) in the United States (where it is known as Stendra). Marketing authorisation for Spedra in the European Union has recently been recommended by the Committee for Medicinal Products for Human Use. On 21 June 2013, the European Commission made its final decision and Vitaros, the pharmaceutical company for the medication, has now the license to market the medication within the European Union.
On 9th July 2013, Vitaros announced its partnership with the Italian company Menarini, which will help market the medication in 40 European countries and also in New Zealand and Australia.