Vitaros topical treatment for ED
The big news in erectile dysfunction over the past few years has been centered on topical application. The news has been filled with stories about gels and Viagra condoms but none of these products have reached pharmacies and doctor offices.
Now Apricus Biosciences is poised to release Vitaros. Vitaros, a topical cream has been approved in Canada and the specialty pharmaceutical company has also filed for marketing approval in the United States. The Canadian approval of the drug can only help its chances, however the FDA is often more stringent with clinical study results before allowing drugs to reach the U.S. market. Several European nations have announced their approval of Vitaros.
Apricus Biosciences announced that in 2013 they will focused on Vitaros and Femprox. In January 2013, Apricus Bio announced its corporate goals for 2013, which includes focusing its corporate strategy and resources on commercializing its lead product Vitaros (alprostadil 0.3% topical cream), for the treatment of erectile dysfunction (“ED”), and on further developing through clinical trials its lead product candidate, Femprox (alprostadil 0.4% topical cream), for the treatment of female sexual arousal disorder (“FSAD”). Both products utilize Apricus Bio’s proprietary NexACT transdermal delivery platform.
San Diego, California-based Apricus Biosciences has licensed the Canadian marketing rights of Vitaros to Abbott Laboratories and the Italian marketing rights to Bracco SpA. The company plans to market Vitaros in more than 100 countries.
What is Vitaros®
Vitaros is a topical formulation of alprostadil. Alprostadil is a vasodilator when absorbed through the skin, directly boosting blood flow causing an erection. Vitaros includes the active ingredient alprostadil, a common FDA-approved vasodilator that is currently sold as an injectable medication, or as an intra-urethral insert product, to treat erectile dysfunction.
Over the past several years, Apricus completed several clinical trials assessing the efficacy and safety of Vitaros. These trials, which administered Vitaros in over 3,300 patients, led to the approval of Vitaros in Canada and, according to the company, positive guidance of its filed marketing authorization application (MAA) in Europe.
Vitaros® differs from oral medications in two ways. First, it is applied locally, directly to the penis as a cream, instead of administered orally as a tablet or injected. This topical application helps to reduce side effects and provides a alternative for men who cannot take the existing oral medications. Second, clinical studies have shown that Vitaros® works in minutes, compared to a reported onset time of 30 minutes, or longer, for oral medications
Currently there are only 3 drugs approved for erectile dysfunction for sale in the U.S. These are Viagra, Cialis and Levitra. A forth drug, Avanafil has won FDA approval. Each of these medications are taken orally as a tablet. Vitaros is applied directly on the penis.
Vitaros Side Effects
Vitaros is reported to be safe for patients who have diabetes or heart problems. Viagra, Cialis and Levitra cannot be taken by patients who take nitrates or alpha blockers, because those medications can cause a drop in blood pressure that could be harmful or even fatal.
Vitaros has both shown effective and safe in the studies involving more than 3,300 patients, including patients who had undergone a prostatectomy.
Some patients during trials reported “penile burning” like sensations. According Vitaros, these were mild, lasting a short period of time. In the studies 6% of patients in the placebo control group (who did not get the drug at all) reported the same penile burning sensation side effect.
Medically speaking “penile burning” includes a sensation of warmth. The sensation of warmth is also evidence of it effectiveness. Vitaros is a strong blood flow inducer so it is normal to feel warmth in the penis. Vitaros is the fastest acting drug currently approved, the blood flow to the penis takes place within minutes of applying Vitaros. The fastest oral erectile dysfunction drug, Avanafil, is reported to take as little as 15 minutes, Viagra can take 30 with Cialis taking even longer.
Who is Apricus Biosciences
Apricus Bio is a San Diego-based pharmaceutical company founded in 1987 with about 35 employees. Apricus stands to gain about $5 million for selling its U.S. rights to the medication. Vitaros is a topically applied medication that was proven in clinical studies to help men perform better in bed. Vitaros is manufactured by Apricus Biosciences, Inc., which sold its U.S. rights for Vitaros to WARNER CHILCOTT COMPANY, which has begun its own process to get FDA approval for Vitaros.
The company’s products includes Vitaros®, approved in Canada for the treatment of erectile dysfunction. The company has several products in development from pre-clinical through pre-registration, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.