Finally, women get a “pink pill”!!!! Sprout Pharmaceuticals Receives FDA Approval of ADDYI™!!!!!!!!!!!!!

By  |  22 Comments

Sprout Pharmaceuticals receives FDA Approval of ADDYI™!!!!!!!!!!!!! First-ever FDA-approved treatment for women’s most common form of sexual dysfunction, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance. Addyi (pronounced add-ee), known generically as Flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.  It is a once-daily, non-hormonal pill. It is estimated that 8 to 14 percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million U.S. women.   I understand that doctors must rule out many issues before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders. Hmmmmmmmmmmmmmmmmm, I was just wandering if these same issues also have to be ruled out before the “blue pill” is prescribed for men????????????

After struggling with her own severe menopause symptoms and doing years of research, Ellen resolved to share what she learned from experts and her own trial and error. Her goal was to replace the confusion, embarrassment, and symptoms millions of women go through–before, during, and after menopause–with the medically sound solutions she discovered. Her passion to become a “sister” and confidant to all women fueled Ellen’s first book, Shmirshky: the pursuit of hormone happiness. As a result of the overwhelming response from her burgeoning audiences and followers’ requests for empowering information they could trust, Ellen’s weekly blog, Menopause MondaysTM, was born.

  • and it had better be covered by insurance as Cialis and Viagra are!

    • Ellen Dolgen

      Roger that, Tam!

  • I think before anyone uses a pill for performance look at your nutrition! Very important in this area.

    • Ellen Dolgen

      Sherry, nutrition is so important to our overall health!

  • Tammy

    The gate has been opened and for that we should all be grateful. However, it’s likely to be slow going getting it covered by insurance companies and for docs to script it. Still….it’s a step in the right direction!

    • Ellen Dolgen

      I am happy the gate was opened! From what I have read, the company is hopeful that many insurance companies will cover the new drug to the same level they cover drugs like Viagra. They are thinking if it IS covered, it most likely will cost women between $30 and $75 a month in out-of-pocket costs. The company may consider offsetting the expenses for women who don’t have insurance so it doesn’t cost them more than that.

  • YOu know,I have mixed feelings. I am not willing to take any more meds than I have to these days. I just don’t think we know enough about effects and I do think the FDA is corrupt. Plus I think we are way too reliant on a pill to fix everything. So I would try every other thing possible before I’d take this.

    • Ellen Dolgen

      I understand what your saying, Carol. However, research and medical advances help us live happy, healthier lives. Probably if it weren’t for the Statin drug…I would not be alive today. When I was a teenager, it was discovered that my cholesterol levels were literally off the charts. My Dad died at 58 due to blocked arteries. His parents did not live to see 60 either. I was put on a heart healthy diet and exercised, but my cholesterol was still at dangerously high levels. I am going to be 62 in a few weeks, primarily because of the Statin drug that I have been taking daily since it was FDA approved. Modern medicine has saved my life. The more options for women suffering from this most common form of sexual dysfunction, the better!

  • I am all for anything that helps people live happier, healthier, more satisfied lives. Let’s hope that the insurance companies treat this the same way they do drugs for men …

    • Ellen Dolgen

      I am with you, Lois!

  • Catherine

    Please note, approved for premenopausal women. It would also be useful to include info on the efficacy of this drug i.e. how many more sexual ‘urges’ per month than placebo…..

    • Ellen Dolgen

      Yes, Catherine, I did make sure to note that is has been approved for premenopausal women in the Health News Flash. However, I have heard some doctors mention that they think the use my expand. I linked to the New York TImes article that did go into more detail on efficacy.

  • I can’t stop thinking about it being the color pink.
    And yes it better be covered by insurance!

    • Ellen Dolgen

      I am not sure if the pill is actually the color pink…………….haven’t seen it yet!!

  • Carol

    Too many potentially dangerous side effects such as seriously low blood pressure, fainting, nausea, dizziness. There’s already concern about it being used as a new “date rape” drug. Also, it has only been shown to have limited efficacy. Not to mention it’s only approved for PREMENOPAUSAL women! What the heck? I guess it’s a start but, really, can we not do better with all our advanced technology and the millions of dollars spent on pharmaceutical research??

    • Ellen Dolgen

      Carol, often these drugs start out with huge controls and stipulations as a cautionary measure. It will remain to be seen how this drug progresses and it’s uses. As for the side effects…. The lists are soooooooooooooooo long. Everything has side affects. Here is the list of side affects of my thyroid medicine that I take daily. No pun intended!
      Chest pain or discomfort
      decreased urine output
      difficult or labored breathing
      difficulty with swallowing
      dilated neck veins
      extreme fatigue
      fainting
      fast, slow, irregular, pounding, or racing heartbeat or pulse
      fever
      heat intolerance
      hives or welts
      increased blood pressure
      increased pulse
      irregular breathing
      irritability
      menstrual changes
      nausea
      pain or discomfort in the arms, jaw, back, or neck
      shortness of breath
      skin itching, rash, or redness
      sweating
      swelling of the eyes, face, lips, throat, or tongue
      tightness in the chest
      tremors
      troubled breathing
      Rare
      Blurred or double vision
      dizziness
      eye pain
      lack or slowing of normal growth in children
      limp or walk favoring one leg
      pain in the hip or knee
      seizures
      severe headache
      I have never experienced one! That being said, I agree with you – women’s health research is behind!

  • Linda

    Thank you Ellen for this great new info! Thankful the people in the white lab coats finally figured out that women need help in this area too…! DUHA!

    • Ellen Dolgen

      I am thankful for those white coats, too! Women need more research and more options!

  • Cheryl

    My husband has worked in pharma for 20 years. An important thing for us all to know is that the FDA requires pharma to list a side effect even if it only happened to ONE person in all the people in all the clinical trials the drug must pass before it’s on the market. That means that the side effects that MAY occur in less than 1 percent of the population are required to be listed (hence, Ellen’s long list of side effects in previous comment!).

    While doctors will first rule out other issues before diagnosing anything, pharma doesn’t get that chance. The one person who had that side effect may have gotten it from any number of other factors, but we’ll never know.

    I’m not currently taking any med’s, and I could experience a few of those side effects Ellen mentioned in any given week! It’s always good to do your research, talk extensively to your doctors, and make a decision that’s right for you and your quality of life. There are many alarmist voices out there, some legit and some not!

    • Ellen Dolgen

      Cheryl, thank you so much for taking the time to shed some light on the protocol for side effects. It is extremely helpful to us “lay people”. I feel that my role is to help makes sure women understand ALL of their options so that together with their healthcare professional, they can make the best decisions for their individual health needs. Of course, these options are constantly changing as new scientific research and discoveries are uncovered. Again, thanks for the great info!

  • Laura Stuart

    Hi Ellen,

    I was wondering if you or any of your readers would kindly give any recommendations for dry hair? My hair used to be oily and now that I’m menopausal, it’s very dry and has frizzy ends. My hair person is not helpful and I’ve tried several shampoos and conditioners.

    All the best,
    Laura

    • Ellen Dolgen

      I am no expert on dry hair…but I use the Devachan products….the shampoo, No Poo, is for dry hair. It doesn’t lather, but keeps my hair moist and happy!