Washington: In what could help millions of women suffering from low sexual desire globally, the US Food and Drug Administration (FDA) has approved the world’s first “female Viagra” to treat acquired and generalised hypoactive sexual desire disorder (HSDD) in premenopausal women.
Named Addyi (also known as flibanserin), the 100 mg “pink Viagra” can be taken once daily at bedtime.
“Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress,” FDA said in a statement released on August 18.
Prior to AddyiÂ’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
“The approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research (CDER).
HSDD is characterised by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
HSDD is acquired when it develops in a patient who previously had no problems with sexual desire.
HSDD is generalised when it occurs regardless of the type of sexual activity, the situation or the sexual partner.
The 100-mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalised HSDD in clinical trials.
“Nearly 1,700 received treatment for at least six months and 850 received treatment for at least one year,” the FDA statement read.
The most common adverse reactions associated with the use of Addyi were dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.
Addyi — marketed by North Carolina-based Sprout Pharmaceuticals – can cause severely low blood pressure (hypotension) and loss of consciousness (syncope).
These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines that interfere with the breakdown of Addyi in the body.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Dr Woodcock continued.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” she noted.
Addyi was approved with a “Boxed Warning” to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi.
In addition, the FDA has asked the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.