It’s here! Well sort of…
The U.S. Food and Drug Administration approved the first prescription drug designed to boost sexual desire in women yesterday. This has been something pharmaceutical companies have been eager to get going on since the HUGE success (no pun intended) of impotence drugs for men.
But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s.
The drug’s label will have a boxed warning — the most serious type — alerting doctors and patients that combining the pill with alcohol can cause dangerously low blood pressure and fainting. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
Medical experts also say this is no quick fix. You have to take it for weeks and months in order to see any benefit at all.
Limited Access
Under a safety plan imposed by the FDA, doctors will only be able to prescribe Addyi after completing an online certification test demonstrating that they understand its side effects. Pharmacies will also have to be certified.
Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
On one side its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug’s launch in mid-October, doctors who frequently see patients complaining about a loss of sexual appetite will have a new option.
Brain Chemicals Affected
The search for a pill to treat women’s sexual difficulties was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological functions all proved ineffective.
Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.
Women and their doctors will have to decide whether the drug’s modest benefits warrant taking a psychiatric pill on a daily basis.
Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.
Opponents of the drug say it’s not worth the side effects, which include nausea, drowsiness, dizziness and fainting that can lead to serious injuries.
The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
Surveys estimate that 8 to 14 per cent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million U.S. women.
SOURCE: FDA, CBC
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