PL-6983 is the New Bremelanotide
It's been quite a while - and quite a 'roller coaster ride' - since our last report on the Bremelanotide Bulletin. There has been both good news and not so good news about the development of Bremelanotide, and you can check out the sections below to learn more about both it and other similar products and drugs currently being tested...
In this Edition, you can read about:
Bremelanotide Time Line
To get you 'caught up to speed' since our last publication, here's a quick timeline of events that begins with Palatin Technologies' submission to the FDA ...
August 30, 2007
The FDA declined Palatin Technologies' application for approval of Bremelanotide to treat erectile dysfunction, citing concerns of increased blood pressure in some test subjects.
However they left open the door to possible future approval as a second line treatment for ED (either in combination with taking Viagra et al, or for men who do not respond to treatment with Viagra).
I've read many comments and theories as to why the FDA declined approval of Bremelanotide, especially in light of the fact Viagra has been approved, even though it has a side effect of lowering blood pressure...
One (conspiracy?) theory relates to the fact the current FDA commissioner appointed by George Bush - Andrew von Eschenbach - is a staunch Texan republican and close friend to the Bush family. I'm not sure if that theory centers on speculation that bible thumping Republicans don't believe an enjoyable sex life is important, or pointing out the fact that Viagra was approved when a Democratic President Clinton was in the White House. :-)
Others have speculated that huge companies (like Pfizer for instance) may have influenced the FDAs decision regarding approval of this relatively small company's competitive product.
And the rejection of Bremelanotide by the FDA is especially puzzling, at least to a "lay person", when seeing posts online (including this one on the Yahoo finance message board for Palatin Technologies) claiming Palatin insiders have told them that only 2% of test subjects experienced a significant increase in blood pressure.
September 10, 2007
Palatin Technologies and King Pharmaceuticals end their collaboration and Palatin regains full rights to the Bremelanotide program.
September 11, 2007
Competitive Technologies announced they presented Palatin Technologies with a Notice of Termination of the PT-14 technology license agreement. For those not aware, CTT "discovered" the original compound that led to PT-141 (Brem's initial designation) via the University of Arizona, and licensed Palatin to develop it in 1998.
This issue was resolved on January 22, 2008 with Palatin paying $800,000 to CTT and maintaining the rights to Bremelanotide, but none of the compounds it stopped developing in 2000 (I assume that refers to the tanning and perhaps weight loss components that were derived from the original discovery).
September 28, 2007
Palatin Technologies announced positive results from an at-home Phase 2 trial evaluating bremelanotide for the treatment of female sexual arousal disorder (FSAD).
Post menopausal women "showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. In these patients, the FSFI domains of arousal, desire and orgasm were statistically significantly improved compared to placebo at one month. The arousal and orgasm domains were statistically significantly improved compared to placebo at one and two months."
Premenopausal women also "showed statistically significant improvements, compared to baseline, in desire and arousal success rates, and overall satisfaction at one and two months."
One interesting statement from tests with premenopausal women was:
"However, while there was a consistent trend to greater improvement in these measures in bremelanotide patients compared to placebo treated patients, the differences were not statistically significant between bremelanotide and placebo treated patients because the placebo responses were themselves statistically significantly improved compared to baseline."
So while this study revealed Bremelanotide definitely does provide improvements for post menopausal women, the premenopausal women had significantly improved sexual results even if they were receiving a Placebo,, which seem to show that in SOME cases, the arousal disorder was "all in the head".
May 14, 2008
Palatin Technologies reported it was abandoning Bremelanotide as a sexual dysfunction drug, and instead will refashion it as a treatment for shock due to blood loss.
However they haven't abandoned this area of treatment entirely... they are beginning studies for a new compound called PL-6983 that works like Bremelanotide but with significantly lower problems related to blood pressure issues.
Iranian scientists report on their results with Bremelanotide tests on men and women
A December 2007 publication reported on clinical trials held in the "Urology and Nephrology Research Center" at 'Shaheed Beheshti University of Medical Sciences' in Tehran, Iran.
In that trial by researcher Mohammad Reza Safarinejad, a total of 80 married women (mean age 31 years) with FSAD were randomly assigned to receive 20-mg of Bremelanotide as an intranasal spray on "as required" basis 45-60 minutes before attempting sexual intercourse, or they received a similar regimen of placebo.
The patients were asked to use at least 20 attempts at home, and the study concluded "the Bremelanotide group reported significantly greater intercourse satisfaction than those in the placebo group."
A study of men with ED was undertaken at the "Urology and Nephrology Research Center" in the Shaheed Modarress Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Those trials results were published in January 2008 by Mohammad Reza Safarinejad and Seyyed Yoosof Hosseini, who conducted the study to evaluate "the safety and efficacy of intranasal Bremelanotide in men with erectile dysfunction who did not respond to sildenafil" (ie. viagra etc).
A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg Bremelanotide as an intranasal spray 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo. Patients were asked to use at least 16 doses/attempts at home.
That study revealed positive clinical results were observed in 51 patients (or 33.5%) in the Bremelanotide group compared with 13 (8.5%) patients in the placebo group.
Patients in the Bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group and the researchers concluded "Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base".
Want to Test New ED and FSAD Treatments?
There are many new drugs being tested for both erectile dysfunction and Female Sexual Arousal Disorder, and one site you can check to see what's being tested and which trials are recruiting new participants (maybe you!) is ClinicalTrials.gov.
Erectile Dysfunction related studies:
Female Sexual Arousal Disorder studies:
You may also want to do your own searches to find specific trials or those that didn't appear in the above links.
- Click here to create detailed parameters and then click 'search'
Other Treatments & Products Related to Sexual Arousal Disorders
There are many reasons people have been looking forward to the production of Bremelanotide - some for casual 'recreational' use (just as Viagra is being used today.. although it's not necessarily recommended for that purpose), to help with minor issues with sexual arousal, as well as serious cases of erectile or arousal disorder in women and men who are suffering genuine quality of life and relationship problems.
Due to the cancellation of Bremelanotide as a treatment for ED and FSAD, and the unknown but certainly lengthy delay for Palatin's new PL-6983 to be developed and available for purchase, the Bremelanotide Bulletin will now investigate and report on many products and drugs (both in development and those eventually available to purchase or have prescribed) that either treat or assist in arousal and related fields of interest.
Below are some of the products and drugs currently being tested or are available to purchase. These items are being presented for your information and not necessarily recommended by the Bremelanotide Bulletin.
Oxytocin
Oxytocin is a hormone that also acts as a neurotransmitter in the brain and known as the "love hormone" or "cuddle hormone".
In humans, it is believed to be released during hugging, touching, and orgasm in both sexes. Oxytocin is also involved in social recognition and bonding, and may be involved in the formation of trust and generosity between people.
In a University of Zurich experiment, people played a "Trust Game", where an investor can give some money to a trustee in the hope that he'll return some.
That test revealed 45% in the oxytocin group showed the maximal trust level, whereas only 21% in the placebo group showed maximal trust .
In contrast, only 21% of the subjects in the oxytocin group had a trust level below 8 monetary units (MU), but 45% of the subjects in the control group showed such low levels of trust.
A researcher at the University of Zurich also stated that women are more susceptible to oxytocin than men, due to enhancing effects of estrogen, so women may show a stronger effect.
After a successful study at the University of Zurich, Oxytocin became much sought after for casual use - to heighten trust in business, socializing, and dating - to more clinical uses, such as treating social and other factors attributed to autism.
Click here for more information and where to buy an Oxytocin product
(NOTE: that website plays sound when loaded)
Libido Patch
This new product is the creation of George Dodds and discussed in an earlier edition of the "Bremelanotide Bulletin" (Bremelanotide at the International Sexologists Conference) ...
It is an aroma patch that is designed to uses a person's sense of smell to enhance sexual response. It describes itself as being a natural approach to increasing a woman's sex drive that doesn't conflict with existing medications a person may be taking.
Click here for more information about this patch
Intrinsa
This is a Procter & Gamble developed patch worn on the abdomen, changed up twice a week, which delivers a low dose of testosterone and (unlike Viagra or Bremelanotide) can take weeks to kick in..
Trials involving over 500 women who had had hysterectomies found the patch led to a 74% increase in satisfying sex. As well as boosting the amount of satisfying sex they had - making love four times more every two months than those wearing a dummy patch - it also increased desire.
The patch is only be available by prescription, mainly to those women who have had an early menopause due to a hysterectomy. These women may require the patch because the process of removing the ovaries reduces testosterone, the male hormone which boosts female desire.
Intrinsa is not available in the United States - the FDA nixed its request to be fast-tracked in 2004 - but can be prescribed by a physician in the UK and perhaps other countries. However Procter & Gamble is in talks with the FDA to identify a possible path toward US approval.
Click here for more information about Intrinsa
LibiGel
Similar to the above treatment (Intrinsa), LibiGel is a a testosterone gel which went into Phase III clinical trials last December. The developing company BioSante claims it is easier to use than a patch which can develop a rash and/or itching, whereas LibiGel can be applied daily to different areas of the body.
NOTE: At the time of this writing, the Libigel website states near the top right: "Find out about participating in one of our clinical trials" - Click here for more information about LibiGel
Flibanserin
That concludes this edition of the Bremelanotide Bulletin.
Subscribe to our newsletter to be informed immediately when our next issue is published!
In this Edition, you can read about:
- The Bremelanotide Time Line (developments since our last issue)
- Test Results of Bremelanotide on Iranian Men and Women
- Current Clinical Trials including some YOU can apply to participate in
- Other Treatments & Products for Sexual Arousal Disorder (men and women)
Bremelanotide Time Line
To get you 'caught up to speed' since our last publication, here's a quick timeline of events that begins with Palatin Technologies' submission to the FDA ...
August 30, 2007
The FDA declined Palatin Technologies' application for approval of Bremelanotide to treat erectile dysfunction, citing concerns of increased blood pressure in some test subjects.
However they left open the door to possible future approval as a second line treatment for ED (either in combination with taking Viagra et al, or for men who do not respond to treatment with Viagra).
I've read many comments and theories as to why the FDA declined approval of Bremelanotide, especially in light of the fact Viagra has been approved, even though it has a side effect of lowering blood pressure...
One (conspiracy?) theory relates to the fact the current FDA commissioner appointed by George Bush - Andrew von Eschenbach - is a staunch Texan republican and close friend to the Bush family. I'm not sure if that theory centers on speculation that bible thumping Republicans don't believe an enjoyable sex life is important, or pointing out the fact that Viagra was approved when a Democratic President Clinton was in the White House. :-)
Others have speculated that huge companies (like Pfizer for instance) may have influenced the FDAs decision regarding approval of this relatively small company's competitive product.
And the rejection of Bremelanotide by the FDA is especially puzzling, at least to a "lay person", when seeing posts online (including this one on the Yahoo finance message board for Palatin Technologies) claiming Palatin insiders have told them that only 2% of test subjects experienced a significant increase in blood pressure.
"It was up to 30 for 2 percent (I spoke to Steven W aka investor relations). The avg was 3. Not a medical person but those few people that hit the 30 mark killed brem."
September 10, 2007
Palatin Technologies and King Pharmaceuticals end their collaboration and Palatin regains full rights to the Bremelanotide program.
September 11, 2007
Competitive Technologies announced they presented Palatin Technologies with a Notice of Termination of the PT-14 technology license agreement. For those not aware, CTT "discovered" the original compound that led to PT-141 (Brem's initial designation) via the University of Arizona, and licensed Palatin to develop it in 1998.
This issue was resolved on January 22, 2008 with Palatin paying $800,000 to CTT and maintaining the rights to Bremelanotide, but none of the compounds it stopped developing in 2000 (I assume that refers to the tanning and perhaps weight loss components that were derived from the original discovery).
September 28, 2007
Palatin Technologies announced positive results from an at-home Phase 2 trial evaluating bremelanotide for the treatment of female sexual arousal disorder (FSAD).
Post menopausal women "showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. In these patients, the FSFI domains of arousal, desire and orgasm were statistically significantly improved compared to placebo at one month. The arousal and orgasm domains were statistically significantly improved compared to placebo at one and two months."
Premenopausal women also "showed statistically significant improvements, compared to baseline, in desire and arousal success rates, and overall satisfaction at one and two months."
One interesting statement from tests with premenopausal women was:
"However, while there was a consistent trend to greater improvement in these measures in bremelanotide patients compared to placebo treated patients, the differences were not statistically significant between bremelanotide and placebo treated patients because the placebo responses were themselves statistically significantly improved compared to baseline."
So while this study revealed Bremelanotide definitely does provide improvements for post menopausal women, the premenopausal women had significantly improved sexual results even if they were receiving a Placebo,, which seem to show that in SOME cases, the arousal disorder was "all in the head".
May 14, 2008
Palatin Technologies reported it was abandoning Bremelanotide as a sexual dysfunction drug, and instead will refashion it as a treatment for shock due to blood loss.
However they haven't abandoned this area of treatment entirely... they are beginning studies for a new compound called PL-6983 that works like Bremelanotide but with significantly lower problems related to blood pressure issues.
Iranian scientists report on their results with Bremelanotide tests on men and women
A December 2007 publication reported on clinical trials held in the "Urology and Nephrology Research Center" at 'Shaheed Beheshti University of Medical Sciences' in Tehran, Iran.
In that trial by researcher Mohammad Reza Safarinejad, a total of 80 married women (mean age 31 years) with FSAD were randomly assigned to receive 20-mg of Bremelanotide as an intranasal spray on "as required" basis 45-60 minutes before attempting sexual intercourse, or they received a similar regimen of placebo.
The patients were asked to use at least 20 attempts at home, and the study concluded "the Bremelanotide group reported significantly greater intercourse satisfaction than those in the placebo group."
A study of men with ED was undertaken at the "Urology and Nephrology Research Center" in the Shaheed Modarress Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Those trials results were published in January 2008 by Mohammad Reza Safarinejad and Seyyed Yoosof Hosseini, who conducted the study to evaluate "the safety and efficacy of intranasal Bremelanotide in men with erectile dysfunction who did not respond to sildenafil" (ie. viagra etc).
A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg Bremelanotide as an intranasal spray 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo. Patients were asked to use at least 16 doses/attempts at home.
That study revealed positive clinical results were observed in 51 patients (or 33.5%) in the Bremelanotide group compared with 13 (8.5%) patients in the placebo group.
Patients in the Bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group and the researchers concluded "Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base".
Want to Test New ED and FSAD Treatments?
There are many new drugs being tested for both erectile dysfunction and Female Sexual Arousal Disorder, and one site you can check to see what's being tested and which trials are recruiting new participants (maybe you!) is ClinicalTrials.gov.
Erectile Dysfunction related studies:
- Click here to find "open" or recruiting trials for ED
- Click here to see all listed clinical trials for ED (to see all drugs being tested)
Female Sexual Arousal Disorder studies:
- Click here to find "open" or recruiting trials for FSAD
- Click here to see all listed clinical trials for FSAD (to see all drugs being tested)
You may also want to do your own searches to find specific trials or those that didn't appear in the above links.
- Click here to create detailed parameters and then click 'search'
Other Treatments & Products Related to Sexual Arousal Disorders
There are many reasons people have been looking forward to the production of Bremelanotide - some for casual 'recreational' use (just as Viagra is being used today.. although it's not necessarily recommended for that purpose), to help with minor issues with sexual arousal, as well as serious cases of erectile or arousal disorder in women and men who are suffering genuine quality of life and relationship problems.
Due to the cancellation of Bremelanotide as a treatment for ED and FSAD, and the unknown but certainly lengthy delay for Palatin's new PL-6983 to be developed and available for purchase, the Bremelanotide Bulletin will now investigate and report on many products and drugs (both in development and those eventually available to purchase or have prescribed) that either treat or assist in arousal and related fields of interest.
Below are some of the products and drugs currently being tested or are available to purchase. These items are being presented for your information and not necessarily recommended by the Bremelanotide Bulletin.
Oxytocin
Oxytocin is a hormone that also acts as a neurotransmitter in the brain and known as the "love hormone" or "cuddle hormone".In humans, it is believed to be released during hugging, touching, and orgasm in both sexes. Oxytocin is also involved in social recognition and bonding, and may be involved in the formation of trust and generosity between people.
In a University of Zurich experiment, people played a "Trust Game", where an investor can give some money to a trustee in the hope that he'll return some.
That test revealed 45% in the oxytocin group showed the maximal trust level, whereas only 21% in the placebo group showed maximal trust .
In contrast, only 21% of the subjects in the oxytocin group had a trust level below 8 monetary units (MU), but 45% of the subjects in the control group showed such low levels of trust.
A researcher at the University of Zurich also stated that women are more susceptible to oxytocin than men, due to enhancing effects of estrogen, so women may show a stronger effect.
Click here to read the Nature Journal of Science article about that test
After a successful study at the University of Zurich, Oxytocin became much sought after for casual use - to heighten trust in business, socializing, and dating - to more clinical uses, such as treating social and other factors attributed to autism.Click here for more information and where to buy an Oxytocin product
(NOTE: that website plays sound when loaded)
Libido Patch
This new product is the creation of George Dodds and discussed in an earlier edition of the "Bremelanotide Bulletin" (Bremelanotide at the International Sexologists Conference) ...
It is an aroma patch that is designed to uses a person's sense of smell to enhance sexual response. It describes itself as being a natural approach to increasing a woman's sex drive that doesn't conflict with existing medications a person may be taking.
Click here for more information about this patch
Intrinsa
This is a Procter & Gamble developed patch worn on the abdomen, changed up twice a week, which delivers a low dose of testosterone and (unlike Viagra or Bremelanotide) can take weeks to kick in..
Trials involving over 500 women who had had hysterectomies found the patch led to a 74% increase in satisfying sex. As well as boosting the amount of satisfying sex they had - making love four times more every two months than those wearing a dummy patch - it also increased desire.
The patch is only be available by prescription, mainly to those women who have had an early menopause due to a hysterectomy. These women may require the patch because the process of removing the ovaries reduces testosterone, the male hormone which boosts female desire.
Intrinsa is not available in the United States - the FDA nixed its request to be fast-tracked in 2004 - but can be prescribed by a physician in the UK and perhaps other countries. However Procter & Gamble is in talks with the FDA to identify a possible path toward US approval.
Click here for more information about Intrinsa
LibiGel
Similar to the above treatment (Intrinsa), LibiGel is a a testosterone gel which went into Phase III clinical trials last December. The developing company BioSante claims it is easier to use than a patch which can develop a rash and/or itching, whereas LibiGel can be applied daily to different areas of the body.
NOTE: At the time of this writing, the Libigel website states near the top right: "Find out about participating in one of our clinical trials" - Click here for more information about LibiGel
Flibanserin
Now the frontrunner in the race to market the first prescription drug for low female sex drive is Boehringher-Ingelheim Pharmaceuticals. It has a drug called Flibanserin in phase III clinical trials, the final phase of drug testing required for FDA approval.
Boehringher-Ingelheim is saying little publicly about the drug, but it's believed it was initially designed to treat depression. as an antidepressant. Boehringher-Ingelheim has does not explained how the drug is supposed to work, other than to say "Flibanserin is a molecule acting on the central nervous system and is not a hormone product."
Click here for more information about FlibanserinPT-141
Competitive Technologies, via the University of Arizona, is the original owner of the Melanotan compound that PT-141 was derived from (aka Bremelanotide). Not much has been said about its plans for PT-141 aside from reports that Competitive Technologies may be looking around for a company to partner with it.
Click here for more information about PT-141
CP-866,087
You can bet this drug will get a new name if and when it ever becomes available, and the fact its being developed by Pfizer makes it a definite player in the FSAD pipeline.
It's currently in Phase II trials and as of the date of this writing, they are recruiting participants.
Click here to read more about a current clinical trialThat concludes this edition of the Bremelanotide Bulletin.
Subscribe to our newsletter to be informed immediately when our next issue is published!
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PL-6983 is the New Bremelanotide
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