Palatin Technologies Release Phase IIb Bremelanotide Results
- Recap: Phase IIa Results (Pre and Post Menopausal Females)
- Summary: Phase IIb Results (Diabetic and Non-Diabetic Males)
- Palatin Technologies Presents at 9th European Society for Sexual Medicine Congress
- Bremelanotide Featured on ABC News Nightline
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.
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..!
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
I 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."Read the entire ABC Nightline article here
"This is not going to make people have orgies in the street," he said.
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!
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Palatin Technologies Release Phase IIb Bremelanotide Results