TAP Pharmaceutical Products Inc has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration for Uprima (apomorphine HCl tablets) sublingual for the treatment of erectile dysfunction (ED). The NDA includes data for 2 mg and 3 mg doses.
Uprima is a tablet that is placed under the tongue and rapidly dissolves prior to intercourse. Uprima is the first in a new class of ED treatment with a mechanism that is thought to be centrally-acting, originating in the brain to help stimulate an erection.
"When approved, we believe that UPRIMA will offer doctors and their patients an important new option for treating ED," says Xavier Frapaise, vice president of Research and Development at TAP.
Erectile dysfunction is defined as the inability to attain and maintain an erection sufficient for intercourse. ED is a common condition estimated to affect about 30 million men in the U.S. including those with partial ED.
"Uprima has been studied extensively in men and, when approved, will provide an alternative for men affected by ED," says John Mulhall, director of Sexual Medicine, Department of Urology, Weill Medical College of Cornell University and Uprima clinical investigator.
In clinical studies, Uprima was administered to men with organic (physical cause), psychogenic (psychological cause) or mixed etiology (combination of physical and psychological causes) erectile dysfunction. Uprima was evaluated for its ability to produce an erection firm enough for intercourse in men with mild, moderate or severe ED.
The most common side effects of Uprima were nausea, headache and dizziness, which were mild to moderate in most cases.
TAP's parent companies, Abbott Laboratories and Takeda Chemical Industries Ltd, currently market apomorphine (as Uprima and Ixense, respectively) in ex-U.S. markets.