Vitaros alprostadil cream & gel
Vitaros is a topical formulation of alprostadil. Alprostadil is a vasodilator when absorbed through the skin as a gel or cream, 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.
One drop of Vitaros rubbed on the glans will generate good results within six minutes. A single application will cost in the area of $10 to $12, similar to the cost of the popular ED pills. It seems the major side effect is that about 6 – 8% of the study group reported penile burning, which,technically, could be as little as a warming feeling.
On the positive side, it is reported that Vitaros does not cause the side effects attributed to the pills (palpitations, vision issues, dizziness, headaches, congestion, etc,)) and hopefully those unable to use the pills due to cardiac concerns, Patients on Nitrates and beta blockers will have success with Vitaros.
Vitaros: The Drug
Many male patients will find Vitaros cream to be more convenient and safer than the current oral medications. Instead of being a pill, Vitaros is applied directly as a cream. When absorbed through the skin Vitaros directly boosts blood flow, thereby causing an erection within minutes — much faster than results from oral medications. The topical application helps to reduce side effects and offers patients a substitute to the current drugs. Vitaros (topical alprostadil and DDAIP for the treatment of Erectile Dysfunction) offers rapid onset with efficacy, tolerability and a favorable safety profile. It has been studied in over 3,300 patients, including difficult to treat populations, those with (diabetes, cardiac issues, sildenafil failures, prostatectomies, patients on nitrates and alpha blockers).
Vitaros Sales in Canada
Vitaros was approved by Health Canada in late 2010. For many months everyone was waiting for a deal to market the drug. Finally, on January 9, 2012 Abbott (ABT) signed an agreement to market Vitaros in Canada and sales are expected to start in 2012. The agreement included $16 million in up-front, and sales milestone payments, as well as royalty payments based on Abbott’s sales in Canada. According to IMS Health data, the annual ED market in Canada in 2010 was about $180 million. In addition, there will probably be some cross-border sales as people from the United States search for a safer and more convenient alternative than the current oral drugs.
Vitaros Approval in Europe
On June 28, 2011 Apricus announced that its marketing application for Vitaros had been accepted for review through the European Decentralized Procedure (EDP). The EDP takes approximately 240 days from the time of acceptance to final approval. Approval would give Apricus the right to sell Vitaros in multiple countries within the European Union. The period of 240 days has passed, which means we should have a decision soon. But Apricus Biosciences stated in their annual report that they expect approval in the first half of 2013 and also expect royalty revenues beginning in late 2013. Apricus’ Vitaros is already partnered in Germany and Italy so sales should start at once.
The deal with Sandoz, a division of Novartis for marketing in Germany, includes $28 million in regulatory and commercial milestones as well as royalty payments. Once Vitaros is approved, other European countries will make deals similar to the Sandoz deal to market Vitaros in countries such as France, Austria, and Spain.
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, Cialisand 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.