A promising alternative to existing forms of treatment for erectile dysfunction has been spreading to markets in far-flung corners of the globe over the past couple of years, but it’s not yet available in the United States. The product is an on-demand topical application developed by San Diego-based Apricus Biosciences (formerly known as NexMed) and marketed under the brand name Vitaros. It is viewed primarily as an alternative for patients who either get no results from the oral drugs or for those taking medications that interact adversely with the oral drugs.
In June 2014, the U.S. Food and Drug Administration rejected Vitaros on the basis of findings from a 2002 animal study that indicated the product exhibited possible carcinogenic effects on transgenic mice. Such mice are genetically modified to create animal models of human disease.
Could Win FDA Approval in 2017
However, Apricus Biosciences is planning to resubmit its application for Vitaros approval in late 2016 and has voiced optimism that the U.S. drug regulatory agency will give the medication its thumbs-up in 2017 this time around. If the company’s predictions prove accurate, Vitaros could be on the American market by late 2017.
Vitaros combines alprostadil, a synthetic version of a naturally occurring prostaglandin already used in other forms of ED treatment, with a unique substance designed to speed transdermal absorption of the drug into the bloodstream. Alprostadil is already available in the United States in both injectible form and as a transurethral suppository. Like the oral ED medications known as PDE5 inhibitors, alprostadil improves blood flow to the penis, thus facilitating erection in men whose vascular systems are somehow compromised.
As currently approved for use in this country, alprostadil is injected directly into the shaft of the penis or inserted in pellet form into the urethral opening at the tip of the penis. By contrast, Vitaros is a cream that can be rubbed into the skin near the tip of the penis. Based on results from clinical trials, the onset of action ranges from 5 to 30 minutes after application, and the duration of action ranges from one to two hours.
The aforementioned clinical trials of Vitaros have shown the topical cream to be an effective and well-tolerated treatment for ED that can be safely used in men who are undergoing treatment with alpha-blockers, antihypertensives, and nitrate-based drugs. This is a stark contrast from the PDE5 inhibitors, which caution against their use at the same time as alpha-blockers, antihypertensives, and nitrates, all of which lower blood pressure. If these drugs are taken concurrently, it can result in a precipitous and potentially life-threatening drop in blood pressure. This type of drug interaction is not a problem with Vitaros.
Tulane Researchers Conduct Review
To evaluate the effectiveness of alprostadil topical creams, Tulane University researchers Wayne J.G. Hellstrom, M.D., and James Anaissie conducted a systematic review of the scientific literature documenting clinical trials of the topical medication. Their findings were previewed online in early August 2016 in advance of eventual publication in “Research and Reports in Urology.”
Dr. Hellstrom and Anaissie looked at studies of alprostadil-based topical creams dating back to 1999, all of which showed that the cream was generally effective for most test participants. However, in the conclusion to their review, they suggest that such creams “can serve as second-line therapy for patients who fail to respond to, or are intolerant of, oral PDE5 inhibitors, and for those in whom these agents are contraindicated or may cause drug-drug interactions.” The review also found that the topical creams are an attractive alternative for patients who prefer to avoid “the invasive nature and side effects of the intracavernous/transurethral administration of alprostadil.”
Second Review Cited
While the review by Dr. Hellstrom and Anaissie considered various formulations of alprostadil-based topical creams, another review published online by “Urologia” in 2015 focused exclusively on Vitaros/Virirec (brand name for the product in Spain). The latter review was conducted jointly by Ignacio Moncada, M.D., head of urology at the Hospital de la Zarzuela in Madrid, and Beatrice Cuzin, M.D., of Hopital Edouard Herriot in Lyon, France.
Drs. Moncada and Cuzin chronicled a study among 161 patients with mild to moderate ED and 142 men with severe ED. That study evaluated the efficacy of Vitaros after 10 drug applications over a six-week period. The primary measure of the medication’s effectiveness were patient scores in the erectile function domain of the International Index of Erectile Function (IIEF).
Other measures of the drug’s effectiveness included change from baseline to final visit in other domains of the IIEF and in the patients’ overall IIEF score, as well as successful vaginal penetrations based on the Sexual Encounter Profile.
Six-Week Study Detailed
Patients in the six-week study were randomly selected to receive topical cream of varying strengths — 100, 200, and 300 micrograms — and a placebo cream identical in appearance to creams containing the active ingredient. Test participants receiving creams with the active ingredient, regardless of strength, all reported significant increases in erectile function. Moreover, the topical cream proved effective for ED patients who for various reasons found the oral PDE5 inhibitors ineffective or incompatible with other medications they were taking.
Side effects from the topical cream containing the highest level — 300 micrograms — of alprostadil were generally mild and tended to disappear upon continued use. Systemic side effects among 434 test participants totaled 13 in all — five experienced dizziness, six reports hypersensitivity of the skin, and two experienced rashes. The most common local side effects, confined to the urogenital area, were penile burning, genital pain, and superficial reddening of the penis.
Valid Option for Any ED Patient
In the conclusion to their review, Drs. Moncada and Cuzin said that Vitaros/Virirec should be considered “a valid therapeutic option in any type of patient affected by ED.” They went on to note that the medication is appropriate for use for all ED patients, “including those not responding to PDE5 inhibitors, and in whom PDE5 inhibitors are contraindicated or not tolerated. It is also suitable for patients who are reluctant to take pills for any reasons, in patients with CV [cardiovascular] risk, and with CV morbidity treated with nitrates.”
Most recently, Apricus on September 4, 2016, announced the market launch of Vitaros in Ireland, Poland, and Portugal, bringing to seven the number of European countries where the medication is now available. In Spain, where it has been on the market for roughly a year, the product is sold under the brand name Virirec.
Licensing Agreement with Recordati
Apricus in February 2014 signed an exclusive licensing agreement with Italy’s Recordati S.p.A. that authorizes the latter to market the topical cream in a number of European, Asian, and African markets. Under the terms of the agreement, Recordati must obtain regulatory approval in all the markets in which it’s been licensed to distribute Vitaros (or Virirec, as it’s known in Spain). In addition to Ireland, Poland, Portugal, and Spain, other countries covered in the licensing agreement include Armenia, Azerbaijan, Belarus, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Georgia, Greece, Hungary, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Romania, Slovakia, Slovenia, Tajikistan, Turkey, Turkmenistan, Ukraine, Uzbekistan, and certain African countries.
Apricus has also struck similar licensing agreements with other pharmaceutical companies to market the topical cream in other geographical territories. It has partnered with Abbott to market the product in Canada and with Takeda to distribute Vitaros in the United Kingdom. Sandoz has been licensed to market the drug in Germany, Switzerland, and certain other northern European countries, while Apricus has partnered with Bracco to market the product in Italy. Majorelle has been licensed to market Vitaros in France, Monaco, and certain African countries.
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