Stendra is a medication that is taken, when needed, 30 minutes before starting sexual activity. Doctors are advised to prescribe the lowest dose at which benefit is provided for the patients.
Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said:
"This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs."
Stendra is a PDE5 (phosphodiesterase type 5) inhibitor, and increases blood flow to the penis. Patients taking nitrates should not be given this medication, the FDA emphasizes. Nitrates are often used to treat angina - combining Stendra with nitrates can bring about a sudden and severe drop in blood pressure.
In very rare cases, patients taking PDE5 inhibitors may experience color vision changes. On rarer occasions, patients may report sudden vision loss in one eye (and sometimes both). Some patients have reported loss of hearing, or decreased hearing. If you experience a sudden loss of hearing or vision you should cease taking any kind of PDE5 inhibitor, and see your doctor immediately.
The following side effects were reported by some patients during human studies: nasal congestion, common-cold symptoms, back pain, face redness, and headache. In rare cases patients may experience priapism - an erection that lasts for hours; in such cases medical help should be sought immediately.
The FDA reviewed three double-blind, placebo-controlled human studies, involving 1,267 patients who were randomly selected to take either Stendra for up to 12 weeks (50, 100 or 200 mg doses), or a placebo, up to 12 weeks, as needed, 30 minutes before sex.
Patients completed questionnaires when the study started, and then every four weeks. The questionnaires asked about erectile function, vaginal penetration, and successful intercourse. In all three studies, a considerably higher number of patients scored well on all three points, compared to those on placebo.
Stendra is marketed by Vivus Inc., Mountain View, California, USA.
Written by Christian Nordqvist