Thursday, June 22, 2006

New News!
Subscribe to the "Bremelanotide Bulletin" on the right side of this page to receive next month's 2010 newsletter with the very latest developments!

Palatin Technologies Release Phase IIb Bremelanotide Results

There have been some very interesting Bremelanotide developments over the past month and, after digesting and absorbing all that data, here is a summary of the latest news...

Recap of the Phase 2a Results for Women
In a November 2006 press release, Palatin Technologies repeated the results of their Phase IIa clinical trial results for both pre-menopausal and post-menopausal women experiencing DSF (female sexual dysfunction).

The results of pre-menopausal women tests were published in the peer-reviewed July 2006 issue of the Journal of Sexual Medicine, and summarized that same month in the "Bremelanotide Bulletin" Phase IIa Report.

In August, the company reported a successful Phase 2A clinical trial in post-menopausal women diagnosed with FSD. Results showed that women reported an increased level of genital arousal and sexual desire and reported a higher incidence of engaging in sexual activity while on bremelanotide compared to placebo.

Palatin Technologies then initiated a Phase 2B "at-home" clinical study with 100 pre-menopausal FSD women. Results from that phase are forthcoming...

Phase IIb Trials with Diabetic and Non-Diabetic Men

In November 2006, Palatin Technologies announced positive results from the two Phase 2B trials evaluating bremelanotide for the treatment of ED (erectile dysfunction).

The primary objective of the studies was to characterize the effectiveness and safety of bremelanotide in both diabetic and non-diabetic men and to identify optimum dose(s) to use in further development...

STUDY 16: Non-Diabetic Men with ED

The 726 participants in this group were in stable monogamous heterosexual relationships, had a mild to severe history of ED for at least 6 months, and discontinued all ED medication, devices, and herbal treatments.

These patients were followed for 3 months. Formal results of the trial follows - skip down to the chart for a quick summary of the results...

The primary efficacy endpoint for both trials was the change in the Erectile Function domain of the International Index of Erectile Function (IIEF-ED) from baseline to the end of the three-month treatment period.

These patients were followed for 3 months and four of the five doses evaluated (7.5, 10, 12.5 and 15 mg) had clinically and statistically significant effects compared to the placebo.

In the Per Protocol Population, IIEF-ED changes ranged from 5.7 for the 7.5 mg dose to 8.4 for the 15 mg dose, compared to 1.8 for placebo.

A change of 4 points from baseline in the IIEF-ED is considered clinically significant.

PT141 Bremelanotide SEP Questionaire test results

In addition to erectile improvements measured above, these same four doses were significantly better than the placebo as measured by the Sexual Encounter Profile (SEP) - specifically the questions related to penetration and ejaculation (see chart below) - and the Global Assessment Questionnaire (GAQ), a subjective questionnaire regarding patient satisfaction with bremelanotide relative to placebo...

The chart above shows the varying dose results for Bremelanotide based on the SEP Questionaire - after subtracting the placebo 'baseline'. (ie. it shows the results of each dose after subtracting what the placebo group reported)
(NOTE: it may be worthwhile to also factor in the "placebo effect" with these numbers - ie. the placebo group's results might also be higher here than they would be if they weren't participating in these trials)

STUDY 17 - Men with ED and Diabetes Mellitus

294 diabetic ED patients were randomized to receive placebo or bremelanotide doses of 10 mg, 12.5 mg or 15 mg doses - similar to the men in Study 16.

In the Per Protocol Population the 12.5 mg and 15 mg doses had a change of 5.9 and 7.1, respectively in the IIEF-ED - placebo change was 2.3.

Although none of the doses evaluated were statistically significantly different from placebo in regards to penetration or ejaculation, all three doses were statistically significantly different than placebo for the GAQ - ie. patient satisfaction with bremelanotide relative to placebo.

Any Bremelanotide Side Effects?

The non-diabetic men in Study 16 experienced some adverse events that were higher for all the doses compared to the placebo group...

These primarily included some instances of nausea, vomiting, flushing (like 'blushing' - a bit red in the face), blood pressure increase, headache, spontaneous erection and nasal symptoms.

Except for flushing and nasal symptoms, the incidence of adverse events were related to the dose amounts. There was one incident of prolonged erection (which, for trials, is classified as a Serious Adverse Event) likely related to bremelanotide.

Adverse events for the diabetic men in Group 17 were similar to Group 16, with the addition of a/some incident(s) of skin darkening. There were two adverse events categorized as "serious" and likely related to bremelanotide: an esophageal tear (likely caused during vomiting) and an incident of prolonged erection.

My assessment... since Viagra (already approved by the FDA) reportedly can cause blindness; I think having a fraction of a precentage of Bremelanotide test subjects experiencing significantly less serious adverse reactions is pretty good..!

Preliminary Conclusions

Based on these and other studies, Palatin and King - along with a Scientific Advisory Board - have determined to continue data assessments as they prepare for an end-of-Phase 2 meeting with the FDA (Federal Drug Association).

Dr. Christopher Steidle, Clinical Associate Professor of Urology at the Indiana University School of Medicine, is an investigator who enrolled patients in both Studies 16 and 17 and a member of the Bremelanotide Scientific Advisory Board...

Dr. Steidle stated:
"There is a need for new agents to treat patients with ED. ...bremelanotide has demonstrated its potential as an effective treatment for patients with ED.

Additionally, given the ongoing unmet medical need of diabetic patients with ED, the efficacy results of the diabetic study (Study 17) are especially encouraging."

Palatin Technologies Presents at the 9th European Society for Sexual Medicine Congress

Results from the Phase 2B trials were presented at the 9th European Society for Sexual Medicine Congress at the Hofburg Convention Center, inVienna on December 5, 2006.

Palatin Technologies Bremelanotide presentation received "The European Society for Sexual Medicine 2006 Award for Best Presentation on Male Sexual Dysfunction (Clinical)."

Click here to see Palatin Technologies' slide show from that event
(Requires Flash. File hosted at the Palatin Technologies website)

Bremelanotide Featured on ABC News Nightline

abc newsI noticed an article on the "Nightline" section of ABC News' website all about Bremelanotide. There was no associated segment on that week's edition of Nightline television show but I have since seen it as an online internet video.

The online article covers a lot of old news already covered in the "Bremelanotide Bulletin", but there a few interesting notes and angles...

Those included an interesting statement from Dr. Annette Shadiack, Director of Research at Palatin, who said: "(Bremelanotide) results last six hours or eight hours, with the onset as early as 30 minutes."

Aha! Not sure if those times depend on the dosage or not, but it narrows down the likely period for results when the final product becomes available.

Female Patients' Bremelanotide Testimonials

Michael Perelman, a New York City sex and marriage therapist who screened women
for Palatin's human trials, was asked what he'd heard from women testing Bremelanotide and was quoted saying:
"Some of the women put it in colorful language that I'm not comfortable using on television."

However the quotes he did feel comfortable sharing included:
"The quality of my orgasm was more the way it used to be, and I like that..."

"I had some thoughts about my husband. I initiated sex with him for the first time even though I've thought about doing it for a long time..."

Drug Abuse Concerns May Prevent Bremelanotide's Release?

But Bremelanotide likely will encounter tough resistance on its way to receiving approval from the Food and Drug Administration...

One concern being touted around includes the possibility it may be abused, along the lines of some young partiers who have been known to mix viagra with Ecstasy for recreational use.

A sexual psychologist by the name of Leonore Tiefer - associate clinical professor of psychiatry at the New York University's School of Medicine - was quoted as saying:

"Certainly when the thing is first approved, I think it will be widely misused."

It's important to note, especially for people who want Bremelanotide to get FDA approval for sale, that in 2004 Tiefer helped block FDA approval for Proctor & Gamble's hormone patch Intrinsa, which was also claimed to be 'the female Viagra'.

And along with concerns for potential abuse, she is also worried about the overall impact these drugs have on our culture. In particular, she's worried about the way it will be marketed.
"It raises the bar on performance expectations. So that women, couples, will somehow feel that if arousal, orgasm, desire, is not a regular routine, every day, every week, womb-to-tomb kind of thing that there is something wrong with you," Tiefer said.

But Palatin Technologies CEO countered that by stating:
"If women do go in with that message, their physician should clearly tell them that this is not what this is for. It's for women who feel a real lack of desire, real lack of ability to get aroused."

That's true - because if Bremelanotide gets approved, it would be the first drug sold in the United States to specifically target lack of sexual desire in women. That's a group that includes women who've gone through menopause or had a hysterectomy and lost desire as a result.

Back in Montreal, Jim Pfaus - the professor of Concordia University's Behavioral Research who successfully tested Bremelanotoide on rats in the early trial phase - says he thinks women should have the option and hopes this treatment will give women confidence, not doubt.

"Women don't need another thing staring at them from a billboard telling them that they are not good enough, but I think that if the drug is available for people who actually have true
desire disorders that are defined by a psychiatrist and a clinical psychologist, then we're talking about a different group of people."

He also said critics should not be overly concerned about Bremelanotide's potency...
"It brings back your libido. It doesn't make it something that it wasn't. It brings it back to where it probably was when you were having good sex."

"This is not going to make people have orgies in the street," he said.

Read the entire ABC Nightline article here

The actual ABC News Nightline VIDEO can be found by clicking here!
(for as long as ABC News leaves it available online)

Conclusion of this Bremelanotide Bulletin Update

Hopefully by this time next year Bremelanotide will be available for purchase and will make an excellent holiday gift for someone special (medicinal purposes only). ;-)

But for now, I'll have to settle with buying a teddy bear for my lady friend and spritzing it with some Pheromone cologne. *grin*

Until the next update - Happy Holidays!

Permanent Link at:
Palatin Technologies Release Phase IIb Bremelanotide Results


Anonymous Anonymous said...


9:17 PM  
Anonymous Bremelanotide Bulletin said...

Although new news is slow in coming for any product going through test phases, another Bremelanotide Bulletin will be sent out to subscribers in the next few days. :)

Thanks for the comment!

1:42 AM  
Anonymous Anonymous said...

Really? Do U think that this product will be available next year? How much the phase III will take? I hope PT-141 will hit the market soon.

12:30 PM  
Anonymous Anonymous said...


4:53 PM  
Blogger Arcana Media said...

Re: Bremelanotide availability...

The CEO of Palatin Technologies did a presentation in October at a BioInvestors Forum and stated (paraphrasing): "2007/2008 will include pivotal trials and safety evaluation with the end of 2008 being the submission for approval" my guess is that last time frame is a decent benchmark for availability. It will depend on how fast the FDA can finish their paperwork too. ;)

BTW, that BioInvestors Presentation is covered in a previous edition of the Bremelanotide Bulletin.


Re: "As a Psychiatrist I am aware that flushing, increase in blood pressure, and nasal congestion are all produced by arousal"

That's a good point!
And even though I am NOT a psychiatrist, I have first hand anecdotal evidence that concurs with your statement! :)

My impression is that some symptoms appear before the actual arousal stage - maybe that's because Bremelanotide works on the brain directly, so the order of indicators is slightly out of synch compared to what we usually see/experience..?

An interesting hypothesis I haven't personally heard of before, so not sure how much of those 'symptoms' are caused by the Bremelanotide and how much is a natural result of the arousal itself...

12:33 PM  
Anonymous Anonymous said...

Is there any way I can obtain a PT-141 nasal spray? I want to test it on my body. Do you think that it would be possible? I am living in Europe. Is there a way of participating to the trials?

6:31 AM  
Blogger Arcana Media said...

There is no way to currently purchase Bremelanotide which is being tested in the U.S. by Palatin Technologies. When it gets FDA approval and available either over the counter or by prescription, that information will be posted here in the Bremelanotide Bulletin.

I'm not sure of the process for its eventual approval in Europe. I would assume FDA approval is not necessarily sufficient for other Countries to automatically approve this treatment.

King Pharmaceuticals is Palatin Technologies' partner for North American rights, as was mentioned in a previous Bulletin, but I'm not aware if Palatin has a partner for marketing rights in Europe yet.

So, as a European, it's possible they may be looking for subjects in Europe at some point - in which case you might be a candidate if you have erectile dysfunction (male) or female sexual arousal disorder.

Alternatively, it MIGHT be possible to order Bremelanotide online at some point. No idea about that for sure, but viagra and cialis et al can be ordered online now so we'll see.

Any future details about the above comments will be posted in upcoming Bremelanotide Bulletin editions as they become available and confirmed.

2:13 PM  
Anonymous wayne said...

Hi. My Wife, Maria, is a Breast Cancer survivor (8 years and counting).However, her cancer was estrogin driven.The chemo and radiation has put her into early menopause,(lumpectomy only)After all her treatments Maria was then put on Tamoxifen.My wife no longer has any desire. I am so happy to have Maria in my life, but it would be nice to "make love", to the woman I am in love with. Is this Drug for cancer survivors? And, did the trials contain any cancer survivors?

12:13 AM  
Blogger Arcana Media said...

Hello Wayne,

I'm very happy to hear your wife was successful in her battle with cancer, and certainly sympathize with the side effects she's experiencing from the Tamoxifen.

If her problems with arousal are directly linked to the Tamoxifen, then perhaps there are other equally effective treatments..?

That's probably something you've investigated already but, if not, I noticed a article that begins with:

"Tamoxifen is the oldest of all the SERMs (Selective Estrogen Receptor Modulators). Tamoxifen is prescribed for women with hormone receptor positive breast cancer before and after menopause.

While tamoxifen is the hormonal treatment of choice for pre-menopausal women, research suggests that tamoxifen is not quite as effective as the aromatase inhibitors for post-menopausal women..."

Which links to:

Failing alternative treatments, and specific to Bremelanotide, there certainly is a chance it may be effective since it works on the part of the brain responsible for arousal.

The female trial participants were most recently categorized as being either pre or post menopausal. No mention was made about medical history that I'm aware of, but I'll see if I can dig that information up.

There is a wide variety of medications that decrease libido as a side effect, so it will be extremely interesting to find out whether Bremlanotide counteracts that problem.

I applaud your obvious devotion to your wife and hope a solution to this situation is quickly forthcoming.

Feel free to visit my newsletter here periodically or sign up for the free email subscription to be informed whenever there is an update. I'll report on Bremelanotide's progress and the moment its approved by the FDA and available for treatment.

Best of luck.

2:25 PM  
Blogger Arcana Media said...

The link above got cut off at the end.

Here is the correct url

2:40 PM  
Anonymous wayne said...

thank-you for the response. my wifes cancer was pre-menopausal, caught very early (2cm, i think), and it was estrogen-receptor-positive breast cancer. Also she did do the 5 years of Tamoxifen, followed by the Femara. It seams that artical was penned by my wife.Thanks again


9:37 PM  
Blogger Fat Bastard said...

I have a fat acceptance blog and my readers were wondering how well this stuff works on fat men with hypogonadism.

Stop by my blog and let us know if you hear anything.

10:47 PM  
Blogger Editor said...

Thanks for posting "FB". :)

A cursory bit of research online seems to indicate low levels of testosterone is being considered as a treatment for hypogonadism...

However, some of those clinical trials are revealing that the testosterone isn't necessarily creating arousal in those patients, even though the testosterone is giving them more 'capability' to perform.

So, similar to the most popular one/two punch associated with Bremelanotide (now PL-6983) - which is a combination of Bremelanotide and Viagra - men experiencing hypogonadism MIGHT benefit from a combination of low level testosterone and PL-6983... whenever it becomes available.

Obviously that type of treatment should be done under the supervision of a physician - likely a requirement anyway, if PL-6983 is available only by prescription - and it's definitely something to consider when PL-6983 or another arousal drug arrives on the market!

Hope that helps answer your question and thanks for visiting. :)

12:50 PM  

Post a Comment

Links to this post:

Create a Link

<< Home