When will Addyi be available?
When will Addyi be available?
It’s been touted as the ‘female viagra’. But when will Addyi be available?
Unless you’ve been living on Mars for the last year or so, you’ve almost certainly heard about Addyi – the controversial “little pink pill” for women that some say is the new ‘Viagra for Women”. But what is Addyi? Addyi is the new “brand” name for Flibanserin – recently approved by the FDA, and now the first prescription treatment for women with low female libido or reduced sex drive.
Addyi, developed by Sprout Pharmaceuticals, was FDA-approved on August 18, 2015 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
When will Addyi be available? The short answer is – “it’s available now!” Addyi became available for sale on October 17 2015 – although with little fanfare – as Sprout Pharmaceuticals agreed not to advertise on radio or TV for a full 18 months after Addyi first became available for sale.
Some pundits have called Addyi the new “viagra for women“- however most medical experts say that’s not very accurate – and the effectiveness of Addyi for most women is still very much up for debate.
Addyi is now the first-ever FDA-approved pill for hypoactive sexual desire disorder (HSDD) in premenopausal women, a revolution for women’s sexual health. Many women will not meet the required conditions (imposed by the FDA) to qualify for taking Addyi.
Addyi is being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment.
Addyi is contraindicated in these patients. In addition, the FDA is requiring 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.
“Where can I get Addyi?”
Although Addyi is now available for women in the USA – it’s far from easy to start taking this drug. Because the FDA was concerned about not only the effectiveness of Addyi, but also the many side effects – some serious – the procedures in place to acquire Addyi are quite strict. Addyi prescriptions can only be issued by doctors which are certified to prescribe the drug. There is a reason why buying Addyi is so complicated.
Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use. The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training.
Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi.
Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.
There can be serious and potentially life threatening side effects from drinking alcohol while taking Addyi – and this is the main reason that the FDA attached so many conditions to the approval of Addyi for treatment of low female sex drive.
Where do you find a doctor certified to prescribe Addyi?
Unfortunately the jury is still out on that question – and at least in the short term Addyi will be quite difficult to come by for the average woman. The FDA rejected the drug twice previously on the basis that it had questionable effectiveness compared to the long list of potential side effects.
For this reason, there are many conditions in place before women can be prescribed Addyi, and only a limited number of doctors and pharmacies are approved at this early stage in the mass marketing of the drug.
The biggest reason for all the hurdles to buying Addyi is the possible complications from taking the drug with alcohol, and the FDA is worried about women taking the drug who don’t realize how serious the consequences can be.
Also, Addyi is targeted at a very select group of women experiencing low female libido for a very specific set of reasons, and because of the potential danger involved – the FDA doesn’t want women taking the drug who could be better served with other products or therapies.
Addyi may provide some improvement for a small circle of women, however many natural female enhancement pills already exist in the marketplace, and many provide far more benefits without the negative side effects – and are helpful for a much broader audience of women.
Several herbal enhancers like Femestril, Provestra, and Hersolution have created extremely effective libido enhancers using only pure and natural ingredients which boost female sex drive without harming your health – and as a bonus, you can still enjoy a glass of wine while taking them!
Perhaps in the future Addyi may become as readily available and easy to find as male enhancement pills like Viagra and Cialis, however it may be a number of years before this happens – if at all. It’s important to understand the major differences between these very different drugs – and the means by which they work.
If you think Addyi might be for you, consult your doctor and get their opinion. If they are not certified to prescribe Addyi, they may be able to point you in the right direction and offer advice on how to get the drug in your area. If you are looking for a simpler and safer way to boost female libido and enjoy more sexual pleasure, try a natural female libido enhancer like Femestril.
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