FDA actions

FDA actions

The FDA has approved the first PDE5 inhibitor in a decade for the treatment of erectile dysfunction (ED). Avanafil (Stendra) joins sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) as the fourth drug approved for this indication. Avanafil will be marketed as having a shorter onset and a shorter half-life than the other drugs in this class. Men should take avanafil as needed 30 minutes before sexual activity with onset of action as quickly as 15 minutes. The approval was based on three randomized, placebo-controlled clinical trials of 1267 patients with ED in which 57% of men achieved erections sufficient for intercourse, up from a baseline of 15% (compared to 27% with placebo). Like other PDE5 inhibitors, avanafil should not be taken with nitrates. Commonly reported side effects include headache, flushing, nasal congestion, nasopharyngitis, and back pain. Avanafil will be marketed by VIVUS of Mountain View, California, as Stendra.

The FDA is requiring new labeling on finasteride — Merck's testosterone blocker used for the treatment of benign prostatic hypertrophy (5 mg as Proscar) and male pattern baldness (1 mg as Propecia). The new labeling addresses sexual adverse events such as libido disorders, ejaculation disorders, orgasm disorders, and even male infertility and poor semen quality. Some of these issues, such as libido disorders and ejaculation disorders, may continue after stopping the drug, while infertility and poor semen quality improve or normalize after discontinuation. The labeling change is based on event reports filed with the FDA, although a clear causal relationship has not been made. Still, the agency is recommending that a discussion of the risks and benefits of finasteride include the possibility of sexual side effects.