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If you have been keeping up with the latest drug news, then you have probably noticed much discussion over the FDA's approval of "Viagra" for women. To help you stay up-to-date with all of the latest developments on this drug, today we are answering a few questions you may be curious about; see below:
What is Addyi™?
Addyi™ has been called “The Female Viagra.” It is used to treat a condition called “generalized hypoactive sexual desire disorder” in premenopausal women. Its generic name is fibanserin. It was initially studied as an antidepressant but has shown to help about 1 in 10 women increase sexual desire. It works on serotonin, a neurotransmitter, in the brain.
What is special about this drug?
It is the first drug FDA approved to treat this condition.
How much will it cost?
Currently unknown, but according to hints from the manufacturer, Sprout Pharmaceuticals, the cost is expected to be a minimum of $400 per month.
Is Addyi™ currently available?
The drug launch is expected to be in October of 2015.
How many people will use Addyi™?
Unknown, but one survey in women aged 18-59 found up to 30% of women lacked sexual desire within a one year period.
Will Addyi™ be heavily marketed?
We expect this to be true. The manufacturer, Sprout Pharmaceuticals, was purchased one day after FDA approval for $1 billion dollars by another drug company, Valeant. The CEO of Sprout, Cynthia Whitehead, who will continue to work under Valeant, has said that it planned to hire 200 sales representatives. In addition she has said that Sprout/Valeant plans to run a patient co-payment assistance program. Read more of what Cynthia had to say in an interview with the International Business Times here.
Is Addyi™ safe?
Addyi™ is associated with nausea, dizziness, fainting and drowsiness. Use with alcohol can lead to severe hypotension and fainting. Alcohol is contraindicated with its use.
What is the FDA doing to ensure drug safety?
Addyi™ will only be available under a program called the Addyi™ REMS program. REMS (Risk Evaluation and Mitigation Strategy) is a FDA mandated program to ensure that the benefits of a drug outweigh its risks. Doctors and pharmacists must pass a comprehension test before prescribing or dispensing this drug.
Is Addyi™ really like Viagra™?
Only in that it treats a sexual dysfunction condition. Viagra™ only works on improving blood flow to the penis, is taken as needed, and is effective nearly all the time. Addyi™ works in the brain, needs to be taken every day, and needs to be taken for up to 8 weeks to see if it is effective. It is only effective 10% of the time.
For more information about Addyi™ and how its approval could impact your current pharmacy benefit plan, or, to simply learn more about your pharmacy benefit plan in general and how it can be affected by any drug approval, please give PBIRx a call at (888) 797-2479 today.