Makers of Vitaros are exploring their options after the product’s new drug application was rejected by the FDA for the second time.
Executives at Apricus Biosciences Inc. hope a mid-April 2018 sit-down with Food and Drug Administration officials will provide a path forward for the company’s proposed Vitaros topical treatment for erectile dysfunction.
The FDA rejected the company’s new drug application (NDA) for Vitaros in February 2018, marking the second time the drug regulatory agency had turned thumbs down on the product, which was previously rejected in 2008.
In its Complete Response Letter (CRL), issued after its rejection of the most recent NDA for Vitaros, the agency indicated that its concerns are focused on deficiencies related to the proposed product’s chemistry, manufacturing, and control. The agency also expressed safety concerns specific to the 2.5 percent concentration of DDAIP hydrochloride in Vitaros. DDAIP hydrochloride is an ingredient added to topical medicinal products to improve the absorption of the active ingredient through the skin.
What Comes Next?
Depending on the specifics of the FDA’s concerns and the work it will take to alter the product to satisfy the agency, Apricus executives will make the decision about whether to press on with Vitaros or abandon the project altogether. Assuming FDA’s concerns can be addressed without a total reformulation of the product, Vitaros is likely to move ahead by making whatever changes are necessary to meet FDA’s approval.
In advance of the April meeting, Richard W. Pascoe, chief executive officer of Apricus, said the company hoped “to further clarify the deficiencies raised in the CRL and the information that may be needed to resolve such deficiencies and to assess the path forward for further development and a potential approval of Vitaros.” He added that the company plans to inform the market of its future plans for the product once it has received and fully digested the minutes from the end-of-review meeting.
A New Approach to ED Treatment
Unlike the current erectile dysfunction products on the market, Vitaros takes a wholly different approach to the problem of male impotence. The product comes in the form of a topical cream containing alprostadil as its active ingredient. Alprostadil, a potent vasodilator, is already in use in penile injection therapy and as a suppository that is introduced to the penis through the urethral opening. As an injectable, the drug is highly effective and fast-acting. It is less effective in its suppository form, a therapy that can cause irritation to the urethral opening upon continued use.
Vitaros is designed to be applied topically to the head of the penis roughly 30 minutes before the anticipated start of sexual activity. It takes effect 5 to 30 minutes after application and its effects last from one to two hours. It has been touted as a useful alternative to the PDE5 inhibitors, particularly for patients who experience bothersome side effects from those oral medications.
PDE5 Inhibitors Could Help
Until the ultimate fate of Vitaros is decided, men who need a little extra boost to achieve and sustain an erection suitable for intercourse can choose from several PDE5 inhibitors currently on the market. These include Viagra, the granddaddy of them all, as well as Levitra, Cialis, Staxyn, and Stendra. Also available is generic Viagra, sold under the name of its active ingredient — sildenafil citrate.
You’ll need a prescription to buy any of these oral drugs. If you have a script from your doctor, you can fill it at the neighborhood drugstore or use it to order the drug online from a reliable online facilitator such as eDrugstore.com. If you decide to go the latter route, you can fax your prescription or scan and email it to eDrugstore along with your order.
Alternatively, eDrugstore can arrange a complimentary online consultation with one of its team of licensed U.S. physicians, any one of whom can authorize a prescription if you’re found to be an appropriate candidate for the drug. To learn more about ED, the medications available to treat it, and the benefits of online ordering, click here to visit eDrugstore’s Erectile Dysfunction page.
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