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Vitaros, a topical cream designed to treat erectile dysfunction, is now available in the United Kingdom and a number of other countries. However, it has not yet won approval from the Food and Drug Administration to be sold in the United States.
Drugs known as PDE5 inhibitors, including Viagra, Levitra, Cialis, and Staxyn, have revolutionized treatment of erectile dysfunction. These drugs are available in pill form, and act systemically, allowing the smooth muscle cells lining blood vessels to relax, thus relieving ED in most men who take them.
However, PDE5 inhibitors aren’t appropriate for all men, and a new drug called Vitaros was launched in the United Kingdom in 2014. Vitaros works differently than Viagra, because rather than being taken as a pill, it is a cream that is applied topically to the penis.
Vitaros Launches in the UK
In mid-June 2014, Vitaros was made available through the National Health Service (NHS) in the United Kingdom, and the product is also available for private physicians there to prescribe. Vitaros is a topical, on-demand treatment for ED. It is made by Apricus Biosciences and distributed by Apricus’ U.K. partner Takeda Pharmaceuticals International.
In announcing the U.K. launch of Vitaros, Apricus CEO Richard Pascoe said, “We are excited to have completed the first of several product shipments of Vitaros to different territories in Europe this year. With the commercial availability of Vitaros in the United Kingdom, Takeda is in a position to finalize its pre-launch activities in an effort to be the first Vitaros commercial partner to offer an on-demand topical cream treatment for men with erectile dysfunction.”
Takeda UK Managing Director Yasuhiro Fukutomi said, “This is an innovative new product that offers the potential to provide men with a new first line or alternative treatment option. Vitaros has been shown in clinical trials to provide rapid efficacy together with convenient local administration that is well tolerated.”
What Vitaros Does
The active ingredient in Vitaros is a drug called alprostadil that has been around even longer than Viagra. Alprostadil is a vasodilator, meaning it dilates blood vessels and boosts blood flow locally. Unlike Viagra, which may have effects throughout the body, Vitaros has only local effects.
What’s revolutionary about Vitaros is that it’s a topical cream. In the past, alprostadil had to either be injected (Caverject is a trade name for the injectable form of the drug.) or inserted into the penis via urethral suppositories. For obvious reasons, men shied away from these forms of the drug. But Vitaros does away with the need for injection or suppositories.
Approval in Europe for Vitaros was given in June 2013, after Phase III clinical trial data showed that nearly 40 percent of men using topical alprostadil in a dosage of 300 micrograms experienced significant improvement in erectile function, compared with 21 percent of men using a placebo. A long-term study found that 90 percent of men using Vitaros for six months believed they had better erections.
Professor Raj Persad of the Bristol Urological Institute told PharmaTimes, “As Vitaros is easy to use and only needs verbal instruction around the application of the cream, it could potentially be prescribed in primary care, giving GPs and practice nurses the ability to treat more men with ED.”
Onset of effects takes around 15 minutes, and those effects are said to last several hours. In a clinical trial of more than 3,300 patients, Vitaros was well tolerated. Most reported side effects were mild and fleeting. More severe side effects with drugs like Viagra (including headache, dizziness, and indigestion) are severe enough to prompt some men to stop taking PDE5 inhibitors. In the United Kingdom, Vitaros is now available as an alternative.
How Vitaros Is Used
Vitaros is simple to use. The cream is supplied in an “AccuDose” container, which looks like a small syringe (with no needle), and contains one dose. It’s available in concentrations of either 2 milligrams per gram or 3 milligrams per gram. After washing hands, the user removes the AccuDose container from the foil packaging and takes off the protective cap. The user then positions the tip of the AccuDose container over (but not in) the opening at the tip of the penis and slowly pushes down the plunger on the container. Results should be felt within 5 to 30 minutes and last for an hour or two. Vitaros should be used only once in a 24-hour period, and not more than two to three times a week.
Who Is a Good Candidate for Vitaros?
Vitaros is approved for use by men age 18 or over who have erectile dysfunction. Any man considering Vitaros should speak with his physician about past and present medications, particularly those that prevent blood clotting or control blood pressure, because these drugs could increase risks of side effects, and the drug may not work as well in these men.
Vitaros should not be used in combination with Viagra or other oral medications for ED, and it should not be used by men with penile implants. Men with blood disorders, leukemia, bone marrow cancer, or who have had a heart attack or stroke are advised not to use Vitaros. Women who are pregnant, breastfeeding, or who could become pregnant should not be exposed to Vitaros. Therefore, men with partners in these categories should use a condom.
Four years after its debut on the U.K. market, Vitaros is still not available in the United States. Its latest petition for FDA approval was turned down in early 2018. Whether it will be reformulated and submitted again before the FDA is unclear.
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