Potential Breakthrough Treatment for Erectile Dysfunction
Futura Medical’s fast-acting topical erectile dysfunction drug MED2005 shows potential as a first-line treatment, following publication of Phase II trial data in the Journal of Sexual Medicine. MED2005 delivers encouraging results with rapid onset of action, significant improvements in Erectile Function scores, and a favourable safety profile
Futura Medical today announced the publication of a Phase II trial of MED2005 in erectile dysfunction (ED) in the Journal of Sexual Medicine.1 MED2005 is a topical gel applied directly to the glans of the penis that contains 0.2% w/w glyceryl trinitrate and DermaSys® technology, an enhanced topical absorption system that facilitates rapid drug delivery across the skin barrier.
The Phase II trial of 230 men with confirmed ED demonstrated that treatment with MED2005 significantly improved their International Index of Erectile Function-Erectile Function (IIEF-EF) score, the gold standard for efficacy measures in ED2 (p=0.0132). Onset of erection occurred within 10 minutes for 70% of participants on average. MED2005 was very well tolerated with no reported serious adverse events related to the treatment in men or their partners, and no withdrawals from the study due to adverse events.
Futura Medical, a pharmaceutical company that focuses on innovative transdermal drug delivery technology, is developing a portfolio of sexual health products with a view to licensing the sales and marketing of these products to major pharmaceutical and healthcare groups.
James Barder CEO, Futura Medical said: “We are extremely encouraged by this Phase II data and in particular the rapid onset of MED2005 which can help restore spontaneity and greater intimacy for men with erectile dysfunction. The excellent safety profile allows us to explore higher dose levels to optimise the efficacy and safety profile of the product. We are also actively continuing our discussions to find the right licensing partner for this exciting product.”
Professor David Ralph Consultant Urologist at St Peter’s Andrology Centre & Institute of Urology, UCLH, London, past President of the European Society of Sexual Medicine, and study author said: “MED2005 has the required efficacy, speed of onset and safety profile consistent for an over-the-counter as well as prescription use product. MED2005, for the first time in the treatment of ED, has the potential to meet the needs of primary care providers and of patients.”
During 2018 Futura Medical will commence a Phase III trial programme to evaluate the safety and efficacy profile of the product at varying dose levels in a larger patient population. Higher doses will be trialled to improve the clinical significance in cases of moderate and severe ED.
Everything You Need to Know About Erectile Dysfunction (ED)
What is erectile dysfunction (ED)?
Erectile dysfunction (ED) is the inability to get or keep an erection firm enough to have sexual intercourse. It’s also sometimes referred to as impotence.
Occasional ED isn’t uncommon. Many men experience it during times of stress. Frequent ED can be a sign of health problems that need treatment. It can also be a sign of emotional or relationship difficulties that may need to be addressed by a professional.
Not all male sexual problems are caused by ED. Other types of male sexual dysfunction include:
delayed or absent ejaculation
lack of interest in sex
What are the symptoms of ED?
You may have erectile dysfunction if you regularly have:
trouble getting an erection
difficulty maintaining an erection during sexual activities
reduced interest in sexOther sexual disorders related to ED include:
anorgasmia, which is the inability to achieve orgasm after ample stimulation。
You should talk to your doctor if you have any of these symptoms, especially if they’ve lasted for two or more months. Your doctor can determine if your sexual disorder is caused by an underlying condition that requires treatment.
What causes ED?
There are many possible causes for ED, and they can include both emotional and physical disorders. Some common causes are:
damage from cancer or surgery
obesity or being overweight
smokingED can be caused by only one of these factors or several. That’s why it’s important to work with your doctor so that they can rule out or treat any underlying medical conditions.
What causes an erection?
An erection is the result of increased blood flow into your penis. Blood flow is usually stimulated by either sexual thoughts or direct contact with your penis.
When a man becomes sexually excited, muscles in their penis relax. This relaxation allows for increased blood flow through the penile arteries. This blood fills two chambers inside the penis called the corpora cavernosa. As the chambers fill with blood, the penis grows rigid. Erection ends when the muscles contract and the accumulated blood can flow out through the penile veins.
ED can occur because of problems at any stage of the erection process. For example, the penile arteries may be too damaged to open properly and allow blood in.
How does age affect incidence of ED?
Up to 30 million American men are affected by ED, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The prevalence of ED increases with age. ED affects:
12 percent of men younger than 60
22 percent of men in their 60s
30 percent of men 70 or olderAlthough the risk of ED increases with age, ED is not inevitable as you get older. It may be more difficult to get an erection as you age, but that doesn’t necessarily mean you will develop ED. In general, the healthier you are, the better your sexual function.
ED can also occur among younger men. A 2013 study found that one in four men seeking their first treatment for ED were under the age of 40. The researchers found a stronger correlation between smoking and illicit drug use and ED in men under 40 than among older men. That suggests that lifestyle choices may be a main contributing factor for ED in younger men.
An analysis of research on ED in men under 40 found that smoking was a factor for ED among 41 percent of men under the age of 40. Diabetes was the next most common risk factor and was linked to ED in 27 percent of men under 40.
How is ED diagnosed?
Your doctor will ask you questions about your symptoms and health history. They may do tests to determine if your symptoms are caused by an underlying condition. You should expect a physical exam where your doctor will listen to your heart and lungs, check your blood pressure, and examine your testicles and penis. They may also recommend a rectal exam to check your prostate. Additionally, you may need blood or urine tests to rule out other conditions.
Nocturnal penile tumescence (NPT) test
An NPT test is done using a portable, battery-powered device that you wear on your thigh while you’re sleeping. The device evaluates the quality of nocturnal erections and stores the data, which your doctor can later access. Your doctor can use this data to better understand your penis function and ED.
Nocturnal erections are erections that occur while you’re sleeping, and they’re a normal part of a healthily functioning penis.
What treatments are available?
Treatment for ED will depend on the underlying cause. You may also need to use a combination of treatments, including medication, lifestyle changes, or therapy.
Your doctor may prescribe medication to help manage your symptoms of ED. You may need to try several medications before you find one that works. These medications can have side effects. If you’re experiencing unpleasant side effects, talk to your doctor. They may be able to recommend a different medication.
The following medications stimulate blood flow to your penis to help treat ED:
Natural remedies and herbs for ED
For some men, natural remedies may help treat ED. Talk to your doctor before trying a new supplement or herb.
You should also use caution when buying supplements and herbs. Many aren’t regulated, which means they may contain additional ingredients not listed on the labels. Ask your doctor to recommend reputable brands and avoid purchasing supplements online.
The following herbs and supplements have been shown to have varying degrees of success for the treatment of ED:
Psychological factors are a common cause of ED, including:
post-traumatic stress disorder (PTSD)
If you’re experiencing psychological ED, you may benefit from talk therapy. Therapy can help you manage your mental health. You’ll likely work with your therapist over several sessions, and your therapist will address things like major stress or anxiety factors, feelings around sex, or subconscious conflicts that could be affecting your sexual well-being.
If ED is affecting your relationship, you may also consider speaking with a relationship counselor. Relationship counseling can help you reconnect emotionally with a partner, which may also help your ED.
If your ED is caused by stress, yoga and massage may help if you find these activities relaxing.
Some men use a form of massage therapy called prostatic massage. Practitioners massage the tissues in and around your groin to promote blood flow to your penis. There are limited studies on the efficacy of this type of massage.
Acupuncture may help treat psychological ED, though studies are limited and inconclusive. You’ll likely need several appointments before you begin to notice any improvements. When choosing an acupuncturist, look for a certified practitioner who uses disposable needles and follows U.S. Food and Drug Administration guidelines for needle disposal and sterilization.
Pelvic floor muscle exercises
A small study of 55 men saw improvement to penile function after three months of regular pelvic floor muscles exercises, and after six months, 40 percent of men had regained normal erectile function.
Kegel exercises are a simple exercise you can use to strengthen your pelvic floor muscles. Here’s how you do them:
Identify your pelvic floor muscles. To do this, stop peeing midstream. The muscles you use to do this are your pelvic floor muscles. Your testicles will also rise when you contract these muscles.
Now that you know where these muscles are, contract them for 5 to 20 seconds. Then release them.
Repeat this exercise 10 to 20 times in a row, three to four times a day.
Lifestyle changes and diet
Healthy lifestyle habits may prevent ED, and in some situations reverse the condition:
Maintain a low blood pressure.
Eat a balanced, nutritious diet.
Maintain a healthy weight.
Avoid alcohol and cigarettes.
Reduce your stress.
ED is often related to problems with your blood flow, so maintaining your blood vessel health through exercise and a healthy diet may help reduce your risk for ED.
Change your medications
In some cases, medications used to treat other conditions may cause ED. Talk to your doctor about medications you’re taking and whether they could be causing your symptoms. There may be other medications you can take instead.
Don’t stop taking medications without first talking to your doctor.
Is ED reversible?
In many cases, you can improve your symptoms of ED. Many medications and treatments are available. As well, certain devices, like an erectile dysfunction pump or erectile dysfunction ring, may help temporarily manage symptoms of ED so that you can continue to engage in sexual intercourse.
ED is a common condition, and it has many possible causes. Discuss your symptoms with your doctor early so that they can rule out underlying causes and begin a treatment plan.
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Medically reviewed by Alana Biggers, MD on May 17, 2017 — Written by the Healthline Editorial Team
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