FDA rejects possible Premarin replacement drugs

SERADA

Serada™, in actual fact, is an investigational formulation of another drug – Gabapentin (Neurontin), an FDA-approved immediate release pharmaceutical – originally developed for the treatment of epilepsy and currently also used to relieve neuropathic pain and vasomotor symptoms (hot flashes) associated with menopause and in women with breast cancer.[8]

What is novel about Serada™ is that it is an Acuform™-enhanced formulation – an extended release version of Gabapentin. Acuform™ delivery technology is Depomed’s unique, patented, polymer-based technology designed to optimize drug delivery. Time release formulas, including extended release types, are specially designed versions of a drug that delay the release of the active ingredient such that it is absorbed by the body over a given period of time. A drug of this formula may have effects that last until the next dosage is taken which can be important in situations in which the medication is designed to alleviate pain for example or halt unpleasant side effects such as is would be the case of hot flashes in menopausal women.

Often these medications sustain desired levels in the bloodstream rather than administering an initial spike with decreasing integrity. Formulated with the Acuform™ drug delivery technology, Serada™ has the promise of both efficacy and fewer side effects commonly observed with the immediate-release formulations of Gabapentin, including dizziness and daytime sleepiness.[9]

LDMP

Low-dose mesylate salt of paroxetine (LDMP) is a selective serotonin reuptake inhibitor (SSRI) with a chemical structure related to paroxetine hydrochloride (brand name Paxil), with lower doses of paroxetine vs. doses prescribed for psychiatric disorders (i.e. those < 20 mg per day).[10]  The use of off-label anti-depressants – for example, paroxitine (Paxil), venlafaxine (Effexor), fluoxetine (Prozac) and sertraline (Zoloft) – to offer some relief of vasomotor symptoms associated with menopause is not new.

SSRIs affect the brain’s use of serotonin, a neurotransmitter, which is believed to play a role in regulating body heat. Purportedly LDMP is unique in that the dosage is 25% less (10 mg) than off-label anti-depressants used to treat psychiatric disorders together with “finding the right dose of the right drug, with an acceptable side effect profile” which to date has not been an easy task.[11]

Clearly a market for Serada™ and LDMP exists as these non-hormonal drugs have the potential to provide women suffering from menopausal hot flashes with new and alternative treatments – options that have more favorable safety profiles than that of conventional HRT containing Conjugated Equine Estrogens (CEE’s) and without exploitation of the mares and their foals.

GOOD NEWS SHORT-LIVED

Foals cast off by the Premarin industry crowd in a feedlot pen await transport to slaughter.
Foals cast off by the Premarin industry crowd around to eat in a feedlot pen before their final journey to a slaughterhouse. Situations like this could have ended for countless young horses if the FDA had accepted instead of rejected HRT drugs Serada and LDMP.

The good news however was short-lived.

On March 4, 2013, the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted that the overall risk/benefit profiles of both Serada and LDMP are not acceptable to support approval.[12][13]

In the case of LDMP the committee voted 7 to 7 that it was effective in treating moderate to severe VMS (vasomotor symptoms) associated with menopause however 10 to 4 that there was not sufficient evidence of its effectiveness to decrease the frequency of VMS events.

Serada fared much worse and was overwhelmingly rejected by the committee both for its risk benefit in treating VMS (12 to 2) and efficacy (13 to 1).

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15 thoughts on “FDA rejects possible Premarin replacement drugs”

  1. Apparently I’m one of the very lucky ones…I actually had to be convinced by my doctor that I had in fact proceeded through the entire menopause syndrome – without knowing it! :)

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  2. Years ago my dr at the time prescribed Premarin. Took it for several months before I found out where it comes from! That was the end of that.

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  3. None of us will ever know how much money Pfizer has shelled out to the FDA over the years. I never took any of the drugs my doctor tried to push on me for hot flashes. I lived in AZ so you really couldn’t tell a hot flash from the 110 degree weather. I never had any problem with it. Not taking any of the drugs probably saved my life.

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  4. Vivian – I love it when you and Jane Allin get your research on; it’s SO important that women understand menopause isn’t a disease nor is it terminal and there are so many alternatives to (you should pardon the crudity) mare piss and slaughtered foals.
    I have to wonder about the hue and cry up from the male population if it were known that Viagra was derived from conjugated bull sperm…(it isn’t, but it amuses me to ponder it so.)
    Is it wicked of me that I actively pursue those vitamin and mineral supplements or herbal remedies that specifically state “This (product) has not been evaluated by the Food and Drug Administration”? It astonishes me this agency is still in business, that it’s recommendation are still held sacred and that it’s opinions carry global weight.
    That’s why these articles are so important, even outside the horse community. Women need to know our health is not now, nor has it ever been, the top priority – our money is.

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    1. Thank you Lisa. Jane has done a stellar job once again. The horses are blessed to have skills working in their defense. Insofar as any of those government alphabets, I feel the same way when I see the USDA sticker on food.

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  5. Many women who have to go on to hormones during menopause, are now using bio-identical hormones which are derived from plants and have less risk.

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  6. Premarin killed my mother,she died 4 years ago from breast cancer. There are safer options out there,I took Prozac for hot flashes and it was like a miracle drug. Went from one hot flash right after another all day every day ….then none at all when I took the Prozac. I took it for 4 years and quit,now I might have one hot flash per day. It works ladies!!

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    1. I used Estradiol as well and it was great! I told my doctor I refuse to take Premarin and she said Estradiol is just as effective. However, she did take me off it after a year and a half (the recommended length of time before risk of breast cancer). She takes her patients off ALL HRT’s after a year and a half, including Premarin due to the same risks. She suggest supplements to replace HRT’s.

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  7. Women like Premarin also because their wrinkles are not as noticeable. But taking the drug can lead to cancer and doctors have taken their patients off of it. Breast cancer is nothing to disregard, while this is criminal for our mares and their foals.

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  8. God forbid that we should stop the suffering of the mares and use something that would not cause harm. There are herbal alternatives out there that work just as good. This is all about the drug companies wanted a hold on your money.

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