New Bremelanotide Results for Women and Video Link
There have been a few new interesting developments in both the progress of Bremelanotide trials and some coverage by news outlets (including a video report).
Here's some of the latest information for you to check out...
Phase IIa Results (Part 2) for Pre and Post Menopausal Women
Part 2 of Phase IIa trials involving post-menopausal women was presented at the International Society for the Study of Women's Sexual Health (ISSWSH) 2007 Annual Meeting.
Palatin reported women who participated in their study described the significant impact that FSD has had on their lives, their self image, relationships, and to a lesser extent, their mood.
These women also expressed a hope to rekindle sexual desire and their ability to become lubricated.
Along with results for post menopausal women, this presentation also revealed new information about the premenopausal group from the interviews they conducted with them.
These tidbits included:
- women experienced a tingling warm sensation about 10 to 45 minutes after their dose.
- intense arsousal that lasted between 6 to 72 hours.
- feelings of arousal preceded feelings of desire (atypical for those subjects)
- they initiated sex with their partner (also atypical for them)
- and they compared their sexual experience on Bremelanotide to how it was before their FSD symptoms began. Those women also reported they were completely focused on sex during the act.
27 women took part in post menopausal group of the Phase IIa study, and completed a 'subjective' questionaire 10 minutes before their dose, 25 minutes after the dose, 55 minutes after the dose, and a "treatment satisfaction index" completed at home 24 hours after the dose.
There was also an in-depth ~30 minute interview with 20 of the postmenopausal women in Hackensack, NJ and Cleveland, OH.
Quotes from Postmenopausal Women Treated with Bremelanotide
Adverse Affects in Phase IIa Subjects
Similar to earlier results, there were some adverse effects in this phase of the trials in this group. Here are the percentages of women who experienced the indicated problems with their dose of Bremelanotide and the Placebo group (as a comparison)...
My Comments: It appears a small percentage of women likely experienced most or all the adverse effects, since the less common problems all show 7.4% of the subjects had them.
It's also quite possible that administering a lower dose will lessen or remove these effects, similar to what the Bremelanotide Phase IIb men's trial revealed.
You can see Palatin Technologies' Power Point presentation from the International Society for the Study of Women's Sexual Health 2007 Conference by clicking here.
Seattle ABC News Affiliate Reports on Bremelanotide
KOMO TV in Seattle, where apparently some elements of the Bremelanotide Trials are being done, filed a report entitled: "Local research aims to boost women's libido".
The article is quite interesting to read, and both it and the accompanying video reveals some new insights into the Bremelanotide trials.
One of the women taking one of the drugs mentioned in the article wrote KOMO TV a letter that reveals how FSAD is both a personal and an intense problem for women...
"It can cause a great deal of discord (and) it can cause marital problems.
What I try to explain to my patients who come to me with sexual dysfunction, is by the time they come to me, there are already relationship issues."
Another Treatment Being Tested for FSAD
The KOMO TV article also mentions another drug being tested for possible treatment of Female Sexual Arousal Disorder called Flibanserin.
And their video report, also available on the above page, can be viewed here.
Phermones Affect Physiology of Women...
Cause Rise in Sexual Arousal
The Journal of Neuroscience published a study by researchers from the University of California at Berkeley on how Phermones affect the physiology of women and cause rise in sexual arousal.
Here is an excerpt from the Louisiana State University newspaper, The Daily Reveille:
Although this physiological reaction is not related to the way Bremelanotide works on both men and women, it is certainly an interesting study and seems to further bolster the research and press reports linked to on the pheromone cologne website that I've mentioned in previous Bremelanotide Bulletins.
I'm hoping to report on more successful Bremelanotide trial results in the very near future!
Here's some of the latest information for you to check out...
- The Journal of Neuroscience published a study by researchers from the University of California at Berkeley about how pheromones affect the physiology of women and cause a rise in sexual arousal. (very loosely related to Bremelanotide)
Phase IIa Results (Part 2) for Pre and Post Menopausal Women
Part 2 of Phase IIa trials involving post-menopausal women was presented at the International Society for the Study of Women's Sexual Health (ISSWSH) 2007 Annual Meeting.
Palatin reported women who participated in their study described the significant impact that FSD has had on their lives, their self image, relationships, and to a lesser extent, their mood.
These women also expressed a hope to rekindle sexual desire and their ability to become lubricated.
Along with results for post menopausal women, this presentation also revealed new information about the premenopausal group from the interviews they conducted with them.
These tidbits included:
- women experienced a tingling warm sensation about 10 to 45 minutes after their dose.
- intense arsousal that lasted between 6 to 72 hours.
- feelings of arousal preceded feelings of desire (atypical for those subjects)
- they initiated sex with their partner (also atypical for them)
- and they compared their sexual experience on Bremelanotide to how it was before their FSD symptoms began. Those women also reported they were completely focused on sex during the act.
27 women took part in post menopausal group of the Phase IIa study, and completed a 'subjective' questionaire 10 minutes before their dose, 25 minutes after the dose, 55 minutes after the dose, and a "treatment satisfaction index" completed at home 24 hours after the dose.
There was also an in-depth ~30 minute interview with 20 of the postmenopausal women in Hackensack, NJ and Cleveland, OH.
Quotes from Postmenopausal Women Treated with Bremelanotide
"It was like when we were dating in 30's and 40's"
"I was 100% into it; I was in the mood"
"I was focused on sex. I wasn't thinking of anything else"
" Improvement in the quality of Climaxes: more intense, lasted longer, able to climax multiple times, more natural."
"Climax was more natural; like pre-menstrual"
"My climax was like it used to be"
"(Climax) quality was better - more intense, lasted longer."
"(Was) able to climax multiple times. That's not usual."
"Ability to orgasm was even easier than when I was 30"
Adverse Affects in Phase IIa Subjects
Similar to earlier results, there were some adverse effects in this phase of the trials in this group. Here are the percentages of women who experienced the indicated problems with their dose of Bremelanotide and the Placebo group (as a comparison)...
My Comments: It appears a small percentage of women likely experienced most or all the adverse effects, since the less common problems all show 7.4% of the subjects had them.
It's also quite possible that administering a lower dose will lessen or remove these effects, similar to what the Bremelanotide Phase IIb men's trial revealed.
You can see Palatin Technologies' Power Point presentation from the International Society for the Study of Women's Sexual Health 2007 Conference by clicking here.
Seattle ABC News Affiliate Reports on Bremelanotide
KOMO TV in Seattle, where apparently some elements of the Bremelanotide Trials are being done, filed a report entitled: "Local research aims to boost women's libido".
The article is quite interesting to read, and both it and the accompanying video reveals some new insights into the Bremelanotide trials.
One of the women taking one of the drugs mentioned in the article wrote KOMO TV a letter that reveals how FSAD is both a personal and an intense problem for women...
"I love my husband. He is more laid back than me. We get along great.
"About seven years ago, I noticed that my interest in sex seemed to fade and it has more or less gone away. Our intimate encounters are about once a month now and it used to be more than once a week! I hope I can fix it."
Dr. Robin Kroll of the Women's Clinical Research Center in Seattle said about female sexual arousal disorders:
"It can cause a great deal of discord (and) it can cause marital problems.
What I try to explain to my patients who come to me with sexual dysfunction, is by the time they come to me, there are already relationship issues."
Another Treatment Being Tested for FSAD
The KOMO TV article also mentions another drug being tested for possible treatment of Female Sexual Arousal Disorder called Flibanserin.
I will begin tracking development of this drug along with Bremelanotide, and will ensure future issues report on any new results or news for that drug as well.
My preliminary research revealed one big difference between the two drugs, specifically that Bremelanotide is a quick acting, short term method to increase arousal.... whereas Flibanserin seems to act more like standard antidepressants like Paxil or Prozac - in the sense it has to be taken for a lengthy period of time before the effects are felt (ie around 4 to 6 weeks) but stays in the system from that point onward as long as the treatment continues.
And their video report, also available on the above page, can be viewed here.
Phermones Affect Physiology of Women...
Cause Rise in Sexual Arousal
The Journal of Neuroscience published a study by researchers from the University of California at Berkeley on how Phermones affect the physiology of women and cause rise in sexual arousal.
Here is an excerpt from the Louisiana State University newspaper, The Daily Reveille:
A study published this week in the Journal of Neuroscience by researchers from the University of California at Berkeley reported men emit chemical compounds in their sweat that affect the physiology of women.
These compounds, called pheromones, have been researched for years to determine their effects on other humans, specifically members of the opposite sex.
According to the study conducted last year, 48 undergraduate women took 20 sniffs from containers of androstadienone, a main component found in male sweat, auxiliary hair, blood and semen secretions.
After testing the levels of cortisol, an adrenal hormone, results showed heightened energy and increased blood pressure that remained at high levels for over an hour, when compared with the sniffing of a controlled odor.
During the test, the female participants had a rise in blood pressure, heart rate and sexual arousal.
John Hogan, chemistry instructor, said researchers realized years ago that animals emitted similar chemical pheromones which affected behavior.
"These compounds aren't actually smelled but picked up by receptor sites in the nose, which emit the chemical to different parts of the brain," Hogan said.
The entire Louisiana State University newspaper article can be read here.
Although this physiological reaction is not related to the way Bremelanotide works on both men and women, it is certainly an interesting study and seems to further bolster the research and press reports linked to on the pheromone cologne website that I've mentioned in previous Bremelanotide Bulletins.I'm hoping to report on more successful Bremelanotide trial results in the very near future!
Permanent Link at:
New Bremelanotide Results for Women and Video Link
28 Comments:
So what's up with the three (out of 3) links being bad? They all require a Blogger login...is that normal just to read a blog?
Whoops - sorry about that. Blogger screwed up the links and I didn't catch those three (they just link down to the headlines lower down on the page, so all the content was still available to read).
It's fixed now and thanks for the heads up. :)
I'm waiting for Palatin to conduct Clinical Trials for post-menopausal women with pathologies. I'm a breast cancer survivor (stage 1 and 2 1/2 yrs out from diagnosis) and my treatment abruptly and dramatically altered my ability to respond sexually. There are many, MANY of us BC survivors who have this same problem and are persistently searching for help and finding nothing!
I can't tell you how excited I am for this drug to be released to those in dire need of it. I am husband to a woman who could greatly benefit from it. We have some relationship issues directly related to her significant lack of libido. She desperately wants to have those desires, but simply does not have them. We are both eagerly awaiting a chance to have her libido improved, that will also improve our relationship. When might we begin to see it available to us? We want to get into her doctor right away once it's approved.
It sounds like your wife would be a prefect candidate for Bremelanotide when trials and FDA approval is complete.
However it may require a doctor's prescription to attain when that happens, so if your wife hasn't already discussed her libido problems with a physician, that may be a good thing to do before Bremelanotide becomes available.
It's also possible there may be alternative treatments her doctor is aware of that she could try in the interim. And failing that, it might be a good idea to have the groundwork laid with a doctor so there won't be any unnecessary delays when Bremelanotide gets FDA approval.
As far as availability is concerned, I typically hear release dates two to three years from now... but, I just read an article that quoted one of the researchers involved with Bremelanotide trials, and apparently he is guessing FDA approval might come in late 2007 or early 2008(!).
So maybe he knows something other speculators don't, or maybe he is mistaken...
But rest assured, whenever a firm release date is announced, I'll be sure to post it on the Bremelanotide Bulletin and send that information out immediately to its subscribers (see top right of this page to subscribe).
Thanks very much for your comments and best of luck!
To the breast cancer survivor who posted above: best wishes to you and congratulations on successfully fighting that terrible disease...
Just within the past year or so I have had one aunt survive cancer and another one lose her life to it very quickly. So even being on the periphery, I know the pain and hardships both the patient and their family & friends go through during that battle.
The only Bremelanotide trials *I* am aware of (though I don't have any special knowledge) is with men experiencing ED and pre/postmenopausal women with FSD/FSAD.
I'm not aware of any subsets to those groups, but I've certainly seen more than a few posts from women with histories similar to your own. And others who have arousal disorders due to head injuries.
So there are a LOT of people who may have new a hope in Bremelanotide and that it becomes available sooner than later.
I don't want to insult you by asking if you've met with a physician to discuss other options (because I'm sure you have. :) ), however just this month the NHS cleared the testosterone patch (Intrinsa) to be available for women with arousal disorders, although the FDA has not approved it yet.
So if you live in the UK that may be an option to discuss with your doctor.
As I mentioned above, someone involved with Bremelanotide research was quoted as saying he believed FDA approval may be as early as late 2007/early 2008... so *if* that was true, you and others may not have TOO long of a wait.
Best regards and thank you for commenting.
I'm a Type 2 diabetic, and I'm on medication for depression. The meds help my depression, but they've killed my libido. Have the trials tested people with this condition?
Where are the Phase 3 trials going to be held? I'd like to participate, if my doctors approve.
I'm a 23 year old Woman and am very scared if this could actually be put into a drink to make one more open to invitations.I'm hoping this is NOT the case at all, Please,PLEASE tell me this is'nt another drug i have to look out for at the club scene!
Re:
>I'm a Type 2 diabetic, and I'm on medication for depression. The meds help my depression, but they've killed my libido. Have the trials tested people with this condition?<
I'm not privy to details not already made public, but trials with men do distinguish between diabetic and non-diabetic men.
But unfortunately it isn't feasible to test Bremelanotide on every possible combination of conditions and medication, and am unsure if any of the men in the trial phases are taking medications. My guess is they would want 'pure' results where the only major differences is some men are diabetic and some are not.
However the primary effect of Bremelanotide is to boost the libido, so it would certainly be a good idea to consult your physician when it becomes available to prescribe.
>Where are the Phase 3 trials going to be held? I'd like to participate, if my doctors approve.<
I'm not sure if that information is available publicly, but this coming weekend there is a conference with two or three presentations about Bremelanotide, including more information about the Phase IIb trials - so perhaps they will also address the phase III trials at that time.
I will be releasing a new issue of the Bremelanotide Bulletin very soon after the conference, so stay tuned! :)
Thanks for your comments and best of luck.
Re:
>I'm a 23 year old Woman and am very scared if this could actually be put into a drink to make one more open to invitations.I'm hoping this is NOT the case at all, Please,PLEASE tell me this is'nt another drug i have to look out for at the club scene!<
You concern is fairly common for those who aren't familiar with how Bremelanotide works.
It is administered via a nasal spray, not a pill, and I cannot imagine many scenarios where a guy could trick a woman into 'snorting' something up her nose without knowing it. :)
And I doubt that "fogging" a room full of Bremelanotide would work either, and the cost would be incredibly high to even attempt such a thing.
Also keep in mind that most (all?) 'date rape drugs' disable the victim to some degree, or render them completely unconscious. While Bremelanotide increases the libido or arouses the person taking it... but it doesn't make them lose their mind and become crazed with lust. :)
So in my opinion, you have nothing to worry about with Bremelanotide in this regard. But of course, as you seem very aware, there are other drugs that can pose a problem so standard safety advice is always a good idea (never leave your drink unattended, only accept drinks from staff at the establishment you're at, etc).
Thank you for your comment and I hope I've helped ease your mind. :)
I have been watching this site for a while now, once I heard about the research on a news program. My libido disappeared about 2 years ago, going through menopause. I have the best husband, he understands completely and is not putting any pressure on me. I on the other hand very much desire to be more my normal self again, and I know he would not be unhappy about that. I am anxiously awaiting the release of this drug. I am also glad to see that males aren't the only ones getting the attention for sexual disfunction anymore. Thank you for working on this issue.
really interesting Blog, a lot information i did not know about.
thanks for the feed back also, clarifies things. keep up the good work.
Thank you 'sleekndsly' for the kudos. :)
I do my best to periodically post some of the latest developments with Bremelanotide along with related subjects I think may be of interest.
I'm hoping to post a new entry by the end of June with some new results I've seen. :)
And to Susan... I'm sorry to hear about the libido issues you are dealing with right now, but am certainly happy you have an understanding husband and ALSO that you appear to be the perfect candidate for Bremelanotide.
As you have no doubt seen in the various postings here, many post-menopausal women testing Bremelanotide have said it brought their libido back again... in spades!
So there is definitely a light at the end of the tunnel, as long as the FDA clears it for public use. If not... well, there are a few other similar products in the pipeline... OR Bremelanotide might get approved in another country, which opens up a couple of other possibilities. :)
So keep reading or stay subscribed to our free Bremelanotide Bulletin 'newsletter'/email alert and I'll keep you apprised of the latests developments and let you know the second Bremelanotide is available for purchase.
Regards and best of luck!
I would like to know how one can become a test subject. My gynecologist has tried just about everything on me and nothing has worked, either pills, creams, etc. All blood work and tests have come back normal. This would be my last hope. I have been married to a wonderful man for 28 years and have not had an orgasm. I did have them when I was younger. Don't know what's up. Please, please, be the answer to a long unanswered prayer.
how do i sign up to be in a trial!?
Ive had fsad my whole life & I cant begin to describe how it has ruined my quality of life. Any ideas as to when this may be available or how to put yourself forward as a potential test subject?
I have read the phase 3 trial rejection(?) by the feds in the last news. OK, fine, I have low blood pressure: typically 90/60. So if they want test subs for a drug that helps low BP ED sufferers then I'd be interested. Since I assume the drug will be by prescrip anyway, the doc will know not to give it to patients w/HBP (duh!). Come on feds, stop being so stiff! ;^D
Advice to fellow readers. Be wary of this site. Any site relying upon a typosquatted version of the word "BremElanotide" (ie: BremOlanotide.com) is very likely to be shady.
Normally I'd delete the above comment, which is in the realm of flame bait as far as I'm concerned....
But instead I will challenge him/her to point out anything on this website that is "shady".
I present the facts as they are announced, generally by Palatin Technologies itself, and any legitimate news coverage of this upcoming treatment.
I also add some insights and opinions to clarify or to show another point of view of some things being discussed.
...And as far as being a typosquatter goes, check out the links on our main page that go to MSNBC, ABC News, Wired, the California Institute of Technology (CalTech) and others that also spell Brem' the very same way.
Do you consider CalTech, MSNBC, and ABC News "shady" as well..?
- Steve
What an easy challenge! One need look no further than the very domain name of this site (ie: the very first impression) to see the shadiness. CalTech, MSNBC, and ABC News have misspelled the word (obviously) and rather than contacting them to suggest proper corrections this site only propagates the error and relies upon them to further enhance the site's appearance of legitimacy.
If you want to clear up this aire of shadiness there would be no simpler solution than to at minimum add a sufficiently prominent explanation on your main page that visitors have landed on a site relying upon the misspelling of the word.
:A Concerned Researcher
Re:"One need look no further than the very domain name of this site (ie: the very first impression) to see the shadiness."
I think we have different definitions for the word "shady".
This website was created to compile information about Bremelanotide for those interested in following its development. Nothing more, nothing less.
>CalTech, MSNBC, and ABC News have misspelled the word (obviously)<
In fact there was an official press release sent out by Palatin Technologies (I assume) in May of 2006 which spelled Bremelanotide with an "o".
>this site only propagates the error and relies upon them to further enhance the site's appearance of legitimacy.<
I think we have different definitions of the word "legitimacy" too.
Bremolanotide.com is a legitimate compilation of news and information about Bremelanotide. And the front page states this website is "not affiliated with Palatin Technologies".
>If you want to clear up this aire of shadiness there would be no simpler solution than to at minimum add a sufficiently prominent explanation on your main page that visitors have landed on a site relying upon the misspelling of the word.<
Although I don't believe we are "relying" on a misspelling of the word at all - nor are we being shady by having the same spelling as used in an official press release (which was the basis for using this domain name) - I don't have a problem pointing out the difference in spelling on our main page, along with the existing clarification that this site isn't affiliated with Palatin Technologies.
I'll add that statement to the main page when I write up the next shady edition of the 'Bremelanotide Bulletin'.
And since you're a concerned researcher you may want to subscriber to our newsletter - if you haven't already - to be sure you don't miss reading all the latest information about Bremelanotide.
- Steve
Ok, my apologies.
I see what happened now. After MSNBC (or another source) reported on a new drug "Bremolanotide" you (or an affiliated person) registered the domain corresponding to this word in that report and subsequently developed this site around it. A number of these sources that you've linked to (Caltech, Wired, Salon, etc.) relied upon that same erroneous report (or reports stemming from the initial one) to write their own web pages. Once I see your updated front page mentioning the misspelling I'll likely sign-up for your bulletin. Take it easy.
-A Less Concerned Researcher
Thanks for your response!
You've described the situation pretty much perfectly. I believe there was an actual press release issued by Palatin Technologies with that spelling of Bremelanotide, and mainstream media etc used that release as a basis for their own articles as I did with the url for this website.
Along the same lines as your initial thoughts, I noticed this site was extolled as a "typosquatter" site by a commenter on Wikipedia too. :)
My thoughts about that is more along the lines of "a rose by any other name would smell as sweet". :)
Glad to hear you're considering signing up for the 'Bremelanotide Newsletter". I hope to have it out soon (especially since it's long overdue) and think people will be interested to read, among other things, the results from Bremelanotide tests performed in Iran!
- Steve
With very very spammy links to "pherlure" (or things similiar) on your site it will likely never be taken very seriously by individuals outside of uninformed members of the general public. As far as people elsewhere thinking that this site is a typosquatting site, it certainly has all of the characteristics of one save for the extenuating circumstances regarding the prevalence of reports relying upon the original "typo". You should provide a link on your site to that initial Palatin press release, that too will enhance the credibility aspects of the main page.
Again my apologies for my unwarranted remarks regarding "shadyness" (which also partially stemmed from that spammishness appearance).
-:- A Bremelanotide Researcher
I have suffered from FSD for a number of years now and I have been to several doctors and had all the blood tests, etc. I have tried testosterone cream, viagra, cialis, etc. but nothing works. Is there anyway that I could signup to be part of the Clincal trials for Bremelanotide.
Thank you for your comments here.
I'm not an insider to the clinical tests with Bremelanotide, but will definitely post here if I find anything...
However I'm actually not quite sure if they WILL need to do more tests for FSD or not. Palatin Technologies only sought approval from the FDA for treatment of ED in men, and it was sent back for further tests due to concerns about increased blood pressure.
So if they can solve that "problem", and get approval from the FDA for treatment of ED, then I would assume they would be able to get approval for treatment of FSD very soon afterwards. At least in regards to any concerns about side effects, since solving any with men would solve them for women too.
So the best news is that you won't be able to sign up to have Bremelanotide tested on you because it's on as close as it's going to get for FDA approval right now. But if that's not the case, and I see anywhere that's seeking subjects for testing, I'll definitely post a message on this site.
Thanks again for writing and hold in there because relief will hopefully be coming soon!
- Steve
Well as you likely are aware, Palatin has decided to cease development of Bremelanotide as a sexual dysfunction drug and instead will focus on developing it for other uses. I imagine if ever they'll be able to gain approval for any particular usage then off label prescriptions for sexual dysfunction will become the norm.
-:- A Bremelanotide Researcher
Hi,
Yes, I had been planning an update here for quite some time now - but the latest news about Bremelanotide was a definite surprise.
As you indicate, Brem is now being tested for another use: a therapeutic drug for treatment of hemorrhagic shock and related indications (shock induced by blood loss, such as secondary to surgery or trauma).
I'm not sure if its approval for that purpose would allow physicians to prescribe it for sexual dysfunction too (as an 'end run'), but that's an interesting idea.
However Palatin Technologies hasn't given up entirely when it comes to treating sexual arousal disorders. As described in their recent press release, they are:
"...advancing new Palatin compound PL-6983, which in animal models causes significantly lower increases in blood pressure than seen with bremelanotide, into Phase 1 clinical studies for treatment of male and female sexual dysfunction"
However that also means we're back to square one in the testing phase.
As you'll see in the next Bremelanotide Bulletin, we'll begin to report on other drugs being tested for the treatment of ED and FSAD because there are a few that aren't that far from completing their clinical trials.
Post a Comment
Links to this post:
Create a Link
<< Home