A committee of specialists at the US Food and Drug Administration (FDA) has recommended that the administration proceed with the approval of a new oral formulation of the drug apomorphine (Uprima) to treat impotence. Doctors predict that it will compete strongly with the highly popular drug sildenafil (Viagra).
Placed under the tongue, the drug encourages erections by stimulating the release of dopamine, which mediates the cerebral role in triggering erections. Although the formulation is new, its active ingredient, apomorphine, has been used for various disorders for many years.
The administration usually follows its panels' advice and is expected to decide by July whether the new formulation can be sold in the United States. The panel's support, however, came with the condition that the manufacturer, TAP, based in Illinois, provides strong warnings to patients about possible serious side effects.
In medical studies almost 60% of men taking the drug had an erection, whereas only 35% of men taking a placebo were able to achieve an erection successfully. A major area of concern was the drug's safety profile, not its effectiveness. Nausea was seen in 32% of the men and dizziness and sweating in about 15
; 60% of the men had to drop out of the studies owing to side effects. Most of these side effects, however, occurred in men taking at least 5 mg of the drug. If approved, the drug will be sold in doses of 2 mg to 4 mg.
Apomorphine also seemed to interact with nitrates and alcohol, leading to concerns about the potential for more serious side effects, such as syncope, hypotension, and bradycardia. Dr Marianne Mann, deputy director of the FDA's division of reproductive and urological drug products, told committee members that these risks need serious consideration; the members agreed. But despite the drug's interaction with alcohol and nitrates, the committee noted that its benefits still outweighed the risks, eventually voting 9-3 in support of approval.
“[Erectile dysfunction] is a major quality of life issue,” said the committee's chairman, Dr Ricardo Azziz.