Spedra is one of the treatments for erectile dysfunction available for sale here at Assured Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about the effectiveness of Spedra. We’ll cover what Spedra is, what it is used for, the mechanism of action and what the results from clinical trials say about the effectiveness of Spedra.
Spedra is the brand name for a medication known as Avanafil. It belongs to the pharmacotherapeutic group known as Urologicals.
Each tablet of Spedra contains either 50 mg, 100 mg or 200 mg of Avanafil. Spedra comes as pale-yellow oval tablets, debossed with “50”, “100” or “200” on one side.
The other substances (excipients) in each Spedra tablet (that are inactive) include Mannitol, Fumaric acid, Hydroxypropylcellulose, Hydroxypropylcellulose – low substituted, Calcium carbonate, Magnesium Stearate, Yellow iron oxide (E172).
The legal category for Spedra (Avanafil) is POM. This means that this medication is a prescription only medicine and it can only be supplied or sold according to the instructions in a prescription issued by a duly qualified and registered doctor or non-medical prescriber.
You should not buy this or any other prescription-only medication without first speaking to a duly qualified and registered healthcare professional like a doctor or non-medical prescriber.
Spedra (Avanafil) is indicated for the treatment of Erectile Dysfunction in adult men.
What is the mechanism of action Spedra?
Spedra (Avanafil) is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Avanafil has no effect in the absence of sexual stimulation.
In vitro studies have shown that Spedra (Avanafil) is highly selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (> 100-fold for PDE6; > 1,000-fold for PDE4, PDE8 and PDE10; > 5,000-fold for PDE2 and PDE7; > 10,000-fold for PDE1, PDE3, PDE9, and PDE11). Spedra (Avanafil) is > 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction. The approximately 20,000-fold selectivity for PDE5 versus PDE3, an enzyme found in heart and blood vessels, is important because PDE3 is involved in the control of cardiac contractility.
In a penile plethysmography (RigiScan) study, avanafil 200 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 20 minutes after dosing and overall response of these subjects to avanafil was statistically significant, compared to placebo, in the 20-40 minute time interval.
Spedra (Avanafil) is rapidly absorbed after oral administration, with a median Tmax of 30 to 45 minutes. Its pharmacokinetics are dose-proportional over the recommended dose range. It is eliminated predominantly by hepatic metabolism (mainly CYP3A4). The concomitant use of potent CYP3A4 inhibitors (e.g. ketoconazole and ritonavir) is associated with increased plasma exposure of avanafil (see section 4.5). Avanafil has a terminal half-life of approximately 6-17 hours.
Spedra (Avanafil) is rapidly absorbed after it has been ingested. Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state. When Spedra (Avanafil) is taken with a high-fat meal, the rate of absorption is reduced with a mean delay in Tmax of 1.25 hours and a mean reduction in Cmax of 39% (200 mg). There was no effect on the extent of exposure (AUC). The small changes in avanafil Cmax are considered to be of minimal clinical significance.
In clinical trials, Spedra (Avanafil) was assessed for its effect on the ability of men with erectile dysfunction (ED) to achieve and maintain an erection sufficient for satisfactory sexual activity. Spedra (Avanafil) was evaluated in 4 randomized, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration in the general population with ED, in patients with Type 1 or Type 2 diabetes and ED, and in patients with ED following bilateral nerve-sparing radical prostatectomy.
The fourth study investigated the onset of action of Spedra (Avanafil) at two doses (100 and 200 mg) in terms of a per-subject proportion of sexual attempts resulting in the satisfactory completion of sexual intercourse. A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively. Patients were instructed to take 1 dose of study medicinal product approximately 30 minutes prior to initiation of sexual activity. In the fourth study, patients were encouraged to attempt sexual intercourse approximately 15 minutes post-dosing, to assess the onset of the erectogenic effect of Spedra (Avanafil), taken on an as-needed basis, at 100 and 200 mg dose.
In addition, a subset of patients was enrolled in an open-label extension trial with 493 patients receiving avanafil for at least 6 months and 153 patients for at least 12 months. Patients were initially assigned to Spedra (Avanafil) 100 mg and at any point during the trial, they could request to have their dose of Spedra (Avanafil) increased to 200 mg or decreased to 50 mg based on their individual response to treatment.
In all trials, statistically significant improvement in all primary efficacy measures was observed for all three doses of Spedra (Avanafil) compared to placebo. These differences were maintained with long-term treatment (as per studies in the general ED population, in diabetics with ED and in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial).
In the general population with ED, the mean percentage of attempts resulting in successful intercourse was approximately 47%, 58%, and 59% for the 50 mg, 100 mg, and 200 mg Spedra (Avanafil) groups, respectively, as compared with approximately 28% for placebo.
In men with either Type 1 or Type 2 diabetes mellitus, the mean percentage of attempts resulting in successful intercourse was approximately 34% and 40% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 21% for the placebo group.
In men with ED following bilateral nerve-sparing radical prostatectomy, the mean percentage of attempts resulting in successful intercourse was approximately 23% and 26% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 9% for placebo.
In the Time to onset study, Spedra (Avanafil) demonstrated statistically significant improvement in the primary efficacy variable (average per subject proportion of successful responses by time after dose administration, to the Sexual Encounter Profile 3 – SEP3) as compared with the placebo, resulting in successful intercourse in 24.71% of the attempts for the 100 mg dose and 28.18% for the 200 mg dose at approximately 15 minutes after dosing compared to 13.78% for placebo.
Across all of the pivotal trials of Spedra (Avanafil), the percentage of successful intercourse attempts was significantly higher for all doses of Spedra (Avanafil) compared to placebo for attempts at all post-dosing time intervals examined.
Is there anything else I need to know about Spedra?
A physical examination may be needed to diagnose the cause of your erectile dysfunction before any medication is prescribed.
If taken with food, it may take a little bit longer for the effects of Spedra to be seen.
If your erection lasts longer than 4 hours, this is known as priapism, you need to seek immediate medical assistance. If you have priapism and it is not treated immediately, there is a very high probability that it could lead to damage of penile tissue and permanent loss of potency may result.
If there is a sudden decrease in your hearing or you suffer a loss of hearing, it is important that you stop taking Spedra immediately and seek urgent medical assistance. The same thing applies if you notice any changes in your vision.
You should not take Spedra and alcohol at the same time as this increases the chances of you getting dizziness, low blood pressure or a condition known as syncope. Syncope is a sudden loss of consciousness caused by a drop in blood pressure.
If you would like more information about Spedra (Avanafil), please click here to fill out our contact form. Alternatively, you may call us on 01625 460 621.
Should you need urgent medical assistance, please dial 999.
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Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected].