Categotry Archives: News

Contrave® for Weight Loss


Contrave, a new medication for weight loss produced by Orexigen Therapeutics, is being tested. This further study was recommended by the Food and Drug Administration (FDA) after the pharmaceutical company submitted the New Drug Application (NDA).

Many studies have already been done to test the drug against a placebo sample population to see its effects on healthy, non-diabetic, obese patients. They have confirmed that the drug, specifically naltrexone plus bupropion, could be an effective treatment to tackle obesity in patients that are found to be appropriate for the medication. However, the FDA has requested the light study to further assess patients’ risk of cardiovascular diseases or complications.

This light study, started in June 2012, will show whether the benefit-risk outline of the medication will be changing or constant. In other words, whether the cardiovascular risks that may be associated with the medication override the weight loss benefits or vice versa. An interim analysis is due to be organised and afterwards, the company is planning on resubmitting its NDA to the FDA.

Takeda has partnered with Orexigen to market the medicine in Mexico, Canada and the United States. Hence, the medication is expected to be available in those countries soon after the FDA approval.

The most common side effect that has been reported by patients in earlier studies was mild to moderate nausea. If you are considering trying this medication, if eventually approved, we recommend a full research on the possible side effects of the drug, and a full consultation with your doctor.

The Update:

Just a couple of days ago Orexigen Therapeutics declared that, within the next few months, they will be able to have more data on major adverse cardiovascular events (MACE). They believe this new data will be sufficient to start the interim analysis. The pharmaceutical company predicts to be able to send the new NDA to the FDA by the end of the current year.

Furthermore, the company has announced that it is planning on submitting the Marketing Authorisation Application (MAA) for the new medication before the start of the interim analysis. The body that will receive the application will be the European Medicines Agency (EMA). However, data detailing the cardiovascular outcomes will be available to the Committee for Medicinal Products for Human Use (CHMP).

We will keep you posted on the situation and update you on any new outcomes.

Vitaros® for Erectile Dysfunction soon available in Europe


Apricus Biosciences has produced a cream called Vitaros®.

In order to accept this medication as a treatment for erectile dysfunction, the Netherlands presented an application that has now been approved through the European Decentralised Procedure by the European Commission. However, the Netherlands was acting as a reference state for the following European countries: Sweden, France, Italy, Ireland, Germany, Belgium, Luxembourg, Spain, and the UK. Therefore, the cream can now be marketed in all these aforementioned countries.

You can read more information on the medication here -

Vitaros® has been created to treat males with Erectile Dysfunction. It is an innovative medication because, since now, the main active ingredient (i.e. alprostadil) had to be either injected or administered via pellet. This cream therefore is a much more appealing way to absorb the medication and many patients, that hadn’t tried alprostadil before, might feel more at ease to trying it. Also, men that have had alprostadil administered in the old ways might want to switch to Vitaros®.

This is not the only product that Apricus Biosciences is working on at the moment. Apparently, they also want to target women. It has been shown that women can get a sexual dysfunction too: namely, Female Sexual Arousal Disorder (FSAD). Keeping alprostadil as the main active ingredient, the pharmaceutical company has been testing the medicine they called Femprox®.  Trials have already been implemented and so we wait for further information about this product and its release date.

Spedra (Avanafil) for Erectile Dysfunction


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 -

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, Vivus 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.

Update 04/04/2014

We understand that Spedra will be available in the UK from 7 April 2014.

There are a few websites that appear to stocking this product. You can find further details here.

Sildenafil Coming Off Patent


Sildenafil is a medicine used by men to treat erectile dysfunction (also called impotence), a disorder whereby a man cannot achieve or has difficulty in keeping an erection hard enough for sexual action. This medication is due to come off patent in 2013 in the European Union so this could lead to substantial price reductions for this popular lifestyle medication.

What is Sildenafil?

Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor. This medicine does not work directly on the penis but on the mechanism that causes an erection during sexual arousal.  When sexually aroused, a naturally-occurring chemical in the body called nitric oxide causes the blood vessels in a man’s penis to relax and open. This enables blood to run in to the penis, fill the tissues, and make it distend. Sildenafil works by raising the level of this natural chemical, thereby relaxing the blood vessels in the penis, leading to an erection.

How to use Sildenafil

You must take sildenafil exactly as explained by your doctor. Sildenafil is taken one hour before you intend to have sex. It usually takes from 30 minutes to one hour to take effect. Sildenafil can be taken before or after a meal, but it may take longer to take effect after a heavy meal or after drinking too much alcohol. It should not be used with any other treatments for erectile dysfunction.

The tablets must be swallowed whole with a glass of water and must not be taken more than once daily. You usually start with a 50 mg dose of sildenafil. The maximum dose is 100 mg and a higher dose will not be more effective. Make an appointment with your doctor if sildenafil does not enable you to have an erection or complete sexual intercourse, or if you feel that the tablet strength is too much for your needs. Do not take more tablets than what your doctor has recommended and tell your doctor if you do.

Who can use Sildenafil?

Sildenafil is only for men who have erectile dysfunction. This medicine is not for women or for children and adolescents. Sildenafil should only be used when you are sexually stimulated otherwise it will not work.

Sildenafil can lower your blood pressure and so it is very important to let your doctor know if you take medicines known as nitrates. You may be taking nitrates if you suffer from chest pain (angina). Similarly, you should also let your doctor know if you take drugs containing nitrites (such as ‘poppers’ that are often taken for recreational purposes). Other medicines that you should inform your doctor about include protease inhibitors (an HIV treatment) and alpha blockers (treatments for high blood pressure and prostate enlargement) as you may need a lower dose of sildenafil.

You should not take sildenafil if you are allergic to it or to any of the other tablet ingredients. Your doctor will want to know if you have an injury or deformity of your penis or Peyronie’s disease. Also mention if you suffer from heart problems, heart disease, low blood pressure, or if you have had a heart attack or stroke. It is important to tell your doctor if you have an inherited eye disease (such as retinitis pigmentosa) or have experienced loss of vision due to an eye condition (non-arteritic anterior ischaemic optic neuropathy or NAION). Other conditions you should tell you doctor about include sickle cell disease, bleeding problems, stomach ulcers, leukaemia, and bone marrow cancer.

Sildenafil side effects

Side effects experienced with sildenafil are usually mild to moderate and do not last long. Common side effects with sildenafil use include headache, flushed face, indigestion, visual disturbances (such as colour tinge, sensitivity to light and blurred vision), blocked nose and feeling dizzy.

It is important to contact your doctor straight away if you get chest pains either during or after sexual intercourse or if you suddenly have a loss of vision. Prolonged and painful erections may occur. If your erection lasts for more than four hours, again you must immediately seek medical attention.

At the current time, Viagra is the only licensed product for erectile dysfunction that contains this active ingredient but this will change when the patent expires. We expect a plethora of suppliers to be applying for licenses to manufacture and sell sildenafil as a generic product in the EU, which is a massive market for pharmaceuticals.

You can read more about sildenafil here -

Update: What is Sildenafil’s current patent status in the UK and other territories?

The pharmaceutical company that holds the patent for Sildenafil is Pfizer.

The first country where Viagra’s patent expired was New Zealand. Sildenafil came off patent in 2011. However, Pfizer did not give up and managed to promote, market and sell its own brand of the generic medication: Avigra.

In the US, the patent is due to expire in April 2020. This is due to two reasons. First because Pfizer, the pharmaceutical company that holds the patent, has won a court trial against Teva that established the extension of the patent up to 2019. The company has also been granted the patent protection for six extra months because of an experimental trial for another medication that uses the active ingredient sildenafil.

In Canada the patent was to expire in 2014, but a court trial established that patent was invalid and has opened the market to generic brands in 2010. In November 2012 Pfizer has asked for a re-hearing to reconsider the court’s decision on the topic.

In the UK, the patent is due to expire on 21st June 2013.

Where can you get Sildenafil from in the UK?

Since Pfizer’s patent for sildenafil has expired, the market has opened up and many companies are now producing generic sildenafil. Nevertheless, Pfizer has also created its own generic version of sildenafil. Hence, men suffering from erectile dysfunction in the UK can now choose between 2 different generic versions of sildenafil. In order to get this medication, a prescription is still needed. It is useful to know, though, that there are online clinics, such as The Online Clinic, that are already able to sell the product starting from Monday, 24th June 2013, after a relevant medical consultation. You can find the link to The Online Clinic in the section above.