US Regulators Approve Addyi, First “Female Viagra’

Rabat – The US Food and Drug Administration (F.D.A) has approved on Tuesday the first ‘female Viagra’, a pill that aims to help women enhance their sexual desire.The drug, called flibanserin and will be marketed under the brand name Addyi, is designed to boost the low sexual drive of healthy women.The F.D.A rejected the pill twice, in 2010 and 2013, citing marginal effectiveness and the side effects. However, an advisory committee of outside experts voted 18-6 earlier this month to recommend that the F.D.A approve the drug with conditions. The pill aims to treat women who suffer from low sexual drive, a condition called Hypoactive Sexual Desire Disorder.“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the F.D.A’s Center for Drug Evaluation and Research (CDER.“The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” she added.The drug should not be used by those who drink alcohol. This can increase the risk of severely low blood pressure (hypotension) and loss of consciousness (syncope).“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Dr. Woodcock.“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.© Morocco World News. All Rights Reserved. This material may not be published, rewritten or redistributed without permission read more