On the Horizon: Bremelanotide and AMAG Pharmaceuticals

After delving back into the wonderfully frustrating and misinformation-filled world of HSDD medications, it looks like it’s not just Addyi that has new updates. It’s also probably a good time to start keeping a closer eye on Bremelanotide  / Vyleesi, a new proposed treatment for HSDD from AMAG Pharmaceuticals.

Unlike Addyi, Bremelanotide is designed to be used only as needed, about 90 min prior to sex. It’s currently being developed to be injected subcutaneously, after other methods showed too many side effects, in particular with worries about low blood pressure. Other common side effects were nausea, flushing, and headaches, which are sure to put you in the mood!

I haven’t had a chance to dig into the proposed method of action, but news articles seem to indicate that it’s neurological, and attempts to balance inhibitory vs. excitatory process in the brain.

It looks like it’s been submitted for new drug consideration by the FDA with an original expected approval announcement in March 2019, but is likely being delayed after the FDA requested more data on side effects.

They’ve also already set up their own website about HSDD as well at unblush.com. It even has it’s own quiz!

I’ve only spent like 20 minutes looking at it so far because I really need to pace myself with these, but here’s a few first impressions:

  1. If you indicate no recent drop in desire in the first question of the quiz, it cuts you off and lets you know that if there’s no decrease, it’s probably not HSDD – which is more than the addyi site is willing to do, so there’s that at least?
  2. On the other hand, if you indicate that your desire has decreased “maybe a little”, but in the questions about negative impact you only mark “I’m afraid my partner will cheat on or break up with me”….it tells you that’s “relationship impact”, a sign of HSDD.
  3. Also, this quiz is like a buzfeed quiz, it’s weirdly full of reaction images and gifs
  4. Both this and some of the ancillary materials for Addyi mention the Decreased Sexual Desire Screener (DSDS), so that’s something I probably want to look into more when I can.
  5. Overall, it’s still manipulative / kinda misleading, but doesn’t seem to be quite as pushy as the addyi site overall – but on the other hand they may just be biding their time because they don’t actually have a drug they can legally push yet.

 

4 thoughts on “On the Horizon: Bremelanotide and AMAG Pharmaceuticals

  1. Both this and some of the ancillary materials for Addyi mention the Decreased Sexual Desire Screener (DSDS), so that’s something I probably want to look into more when I can.

    I looked up the DSDS today and found a pdf article about it here. Looks like it’s basically just this:

    —–

    Dear Patient,
    Please answer each of the following questions:

    1. In the past was your level of sexual desire or interest good and satisfying to you? Yes/No
    2. Has there been a decrease in your level of sexual desire or interest? Yes/No
    3. Are you bothered by your decreased level of sexual desire or interest? Yes/No
    4. Would you like your level of sexual desire or interest to increase? Yes/No
    5. Please check all the factors that you feel may be contributing to your current decrease in sexual desire or interest:
    A: An operation, depression, injuries, or other medical condition
    B: Medication, drugs or alcohol you are currently taking
    C: Pregnancy, recent childbirth, menopausal symptoms
    D: Other sexual issues you may be having (pain, decreased arousal or orgasm)
    E: Your partner’s sexual problems
    F: Dissatisfaction with your relationship or partner
    G: Stress or fatigue

    When complete, please give this form back to your clinician

    Clinician:

    Verify with the patient each of the answers she has given.

    The Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, characterizes Hypoactive Sexual Desire Disorder (HSDD) as a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric, or other sexual condition. HSDD can be either generalized (not limited to certain types of stimulation, situations, or partners) or situational, and can be either acquired (develops only after a period of normal functioning) or lifelong.

    If the patient answers “NO” to any of the questions 1 through 4, then she does not qualify for the diagnosis of generalized acquired HSDD.

    If the patient answers “YES” to all of the questions 1 through 4, and your review confirms “NO” answers to all of the factors in question 5, then she does qualify for the diagnosis of generalized acquired HSDD.

    If the patient answers “YES” to all of the questions 1 through 4 and “YES” to any of the factors in question 5, then decide if the answers to question 5 indicate a primary diagnosis other than generalized acquired HSDD. Co-morbid conditions such as arousal or orgasmic disorder do not rule out a concurrent diagnosis of HSDD.

    Based on the above, does the patient have generalized acquired Hypoactive Sexual Desire Disorder?
    ____YES____NO

    —–

    (bolding added by me)

    So if a woman isn’t happy about decreased desire and there aren’t any other factors to explain it, according to this metric, she has HSDD. That’s… not great. It’s at least not going as far as the Sprout quizzes that are overeager to pathologize low desire even if there’s no accompanying distress, but how are you supposed to reconcile this with a community that includes people who used to think they were “broken” & people who used to identify with other sexuality labels? I don’t think we should bank on “you can identify as asexual as long as you’ve been asexual your whole life and have never had a problem with it” as a source of safety.

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