Futura Medical launches final clinical trials of a new topical treatment for erectile dysfunction. Its immediate goal is to win approval to market the drug in Europe, but it has its eye on the American market down the line.
A new topical treatment for erectile dysfunction took another step closer to approval in Europe with the recent announcement that its developer has launched the final phase of clinical trials on the product. Futura Medical, based in the United Kingdom, announced in September 2018 that preparations were well underway for the commencement of Phase III trials of MED2002 in Eastern Europe.
If it wins approval from the European Medicines Agency, the formal body responsible for approving medicinal products to be marketed within the European Union, MED2002 would become the second topical ED treatment available in Europe. The other is Vitaros, a topical gel that was developed by Apricus Biosciences but is marketed outside the United States by Ferring Pharmaceuticals.
Rival Gel Approved in 2013
Vitaros was approved by the Netherlands in June 2013. Under the European Decentralized Procedure, the Netherlands served as the reference member state on behalf of nine other EU member states, namely Belgium, France, Germany, Ireland, Italy, Luxembourg, Spain, Sweden, and the United Kingdom. Apricus’s efforts to win FDA approval to market Vitaros in the United States hit a roadblock in early 2018 when the drug regulatory agency rejected the product for a second time.
MED2002’s active ingredient is glyceryl trinitrate, also known as nitroglycerin, a powerful vasodilating medication that improves blood flow in the penis when applied topically. By contrast, the active ingredient in Vitaros is alprostadil, a drug already widely used in penile injection therapy and as a transurethral suppository. The FDA’s current objections to Vitaros have nothing to do with alprostadil but focus instead on the gel’s high concentrations of DDAIP hydrochloride, a substance designed to speed transdermal absorption of the active ingredient.
MED2002 Offers an Alternative
Futura has touted MED2002 as an alternative ED treatment for men who either don’t respond to Viagra or other PDE5 inhibitors or experience adverse side effects from those oral medications.
Outlining its plans for Phase III trials of MED2002, Futura said the trials will be conducted in Eastern Europe and will involve a three-month study period for each patient. The study will compare the efficacy of varying doses (0.2, 0.4, and 0.6 percent) of glyceryl trinitrate to the effects of placebo.
As Futura forges ahead with the final phase of clinical trials of MED2002, the company also reported that it was in the advanced stages of negotiations to license rights to a partner that could market the product. Futura Chairman John Clarke expressed the hope that such a deal could be finalized soon.
Futura Sets Sights on US Market
Futura also signaled its hopes to bring MED2002 to the U.S. market eventually, noting that the highest concentration of active ingredient — 0.6 percent — to be tested was considered the maximum dose likely to win FDA approval.
In the meantime, Viagra and the other PDE5 inhibitors remain the best hope for men suffering from vascular-related ED in the United States. If the convenience of ordering such drugs online appeals to you, check out what eDrugstore.com has to offer. Click here to visit eDrugstore’s Erectile Dysfunction page where you can learn more about ED, its causes, and the drugs available to treat it.
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