What is Spedra - Avanafil used for?
Spedra is a medicine used to treat adult men with erectile dysfunction (also called impotence), which is the inability to achieve or maintain an erection sufficient for satisfactory sexual activity. For the medicine to be effective, sexual stimulation is required.
It contains the active ingredient avanafil .
How is Spedra - Avanafil used?
Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription. The recommended dose is 100 mg, taken approximately 15 to 30 minutes before a sexual relationship; patients should not take more than one dose a day. Spedra can be taken on a full or empty stomach. If taken on a full stomach, it may take longer for the medicine to start working. The dose can be adjusted where necessary; lower doses may be needed in patients with liver problems or taking certain other medicines. For more information, see the package leaflet.
How does Spedra - Avanafil work?
The active substance of Spedra, avanafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)". It works by blocking the enzyme phosphodiesterase, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). The cGMP is produced in the penis during normal sexual stimulation, where it causes the relaxation of the muscles of the cavernous bodies (the spongy tissue present in the penis), which favors the flow of blood in the cavernous bodies and, therefore, an erection. By blocking cGMP degradation, Spedra enhances its effect on erectile function. However, sexual stimulation is still needed to produce an erection.
What benefit has Spedra - Avanafil shown during the studies?
Spedra has been studied in three main studies involving 3 400 patients with erectile dysfunction. The first study involved patients recruited from the general population; however, as some conditions associated with erectile dysfunction could affect the response to treatment, the second study mainly involved patients with erectile dysfunction and diabetes and the third study subjects with erectile dysfunction secondary to prostate surgery. In these studies, which lasted 12 weeks, different dosages of Spedra taken about 30 minutes before a sexual relationship were compared with placebo (a dummy tablet). The main parameters of effectiveness in all three studies were the percentage of erections of sufficient duration to allow a complete sexual relationship, the percentage of vaginal penetrations and the variations of the score for the evaluation for erectile function. In all studies Spedra was more effective than placebo. In the first study, Spedra, taken about 30 minutes before a sexual relationship at a dose of 100 or 200 mg, increased the percentage of complete sexual intercourse from about 13% before treatment to about 57%, while the placebo only led to an increase by 27%. Compared to placebo, the medicine also allowed about 60% more vaginal penetrations. The improvement in the assessment score was approximately 5-7 greater than with placebo. A further study was carried out involving 440 adults with erectile dysfunction, in which Spedra was taken around 15 minutes before a sexual relationship. The percentage of successful attempts was about 28% with Spedra taken at a dose of 200 mg and about 25% with a dose of 100 mg, compared to 14% with placebo.
What is the risk associated with Spedra - Avanafil?
The most common side effects of Spedra (which may affect up to 1 in 10 people) are headache, skin redness and nasal congestion; Back pain that may affect one in 100 people has also been reported. For the full list of side effects reported with Spedra, see the package leaflet. Before prescribing Spedra, doctors must take into account the potential risks of sexual activity in cardiac patients. The medicine should not be used in people with severe heart or circulatory problems, including patients who have had a heart attack, stroke, or severe arrhythmia (heart rhythm irregularity) in the last six months and those with unstable angina (severe type of chest pain), angina pectoris during intercourse, heart failure or hyper- or hypotension. It must also not be used by patients with severe impairment of hepatic or renal function and by subjects who have experienced loss of vision due to anterior ischemic optic neuropathy (ie due to a problem with the blood supply to the optic nerve), which can be triggered from this class of medicines.
Spedra must not be taken in combination with certain other medicines, including nitrates (a type of medicine used to treat angina pectoris), or with medicines that greatly reduce the demolition of Spedra in the body. For the full list of limitations, see the package leaflet.
Why has Spedra - Avanafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo in allowing sexual intercourse to be completed. However, the fact that the medicine has not been directly compared to other medicines in its class makes it difficult to assess its potential role in the treatment of erectile dysfunction. In terms of safety, the side effects are similar to those seen with other drugs of the same class. The Committee therefore decided that Spedra's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Spedra - Avanafil?
A risk management plan has been developed to ensure that Spedra is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and the package leaflet of Spedra, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Spedra - Avanafil
On 21 June 2013, the European Commission issued a marketing authorization for Spedra, valid throughout the European Union.
For more information about Spedra therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
