Abstracted from Reuters News Services
NDA Filed by TAP Pharmaceuticals
CHICAGO (Reuters) -- TAP Holdings Inc. announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for Uprima (apomorphine), an oral agent for treatment of erectile dysfunction. The FDA evaluation process is expected to take approximately one year. If approved, Uprima would be the second available pill for impotency. Viagra (sildenafil) was the first, being approved by the FDA on March 27, 1998 and it quickly became the best-selling new drug in history.
Both drugs are effective via the Nitric Oxide pathway for erection. However, Viagra acts directly on erectile tissue by inhibiting phosphodiesterase (PDE-5) in corporal smooth muscle. Uprima is classified as a central dopaminergic agent; its action results in increased neural impulses sent from the brain to the erectile tissues, with ensuing increase of blood flow to the erectile bodies.
Phase III trial data were presented at the 94th annual meeting of the American Urological Association in Dallas, TX. In that study, detailing results in 520 men treated with varying doses of Uprima or placebo, an erection satisfactory for intercourse was reported at all dosage levels. The commonest side effect was nausea.