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The New Sex Shot? Why is PT-141 (Bremelanotide) not prescribed for Erectile Dysfunction?   

The New Sex Shot? Why is PT-141 (Bremelanotide) not prescribed as an ED cure?
PT-141 (Bremelanotide) is a naturally occurring protein that stimulates the release of essential reproductive hormones in our brains. Originally synthesized in the lab as a tanning agent in the 1970s, interest in PT-141's sexual application started when a male lab chemist got a prolonged erection after accidental self-medication. Early studies on mice backed up his experience; increased sexual arousal and copulation in both male and female lab mice, and presumably a lot more mice.  

PT-141 has since been subject to successful phase 2 and 3 trials in the USA and is approved by the Food and Drug Administration (FDA) as treatment for women experiencing low sexual desire, particularly during menopause, under the brand name Vyleesi. But the male patient trials were never completed, despite evidence that PT-141 can increase sex drive and stimulate erections. So, although we know it is safe and effective (unlike Kisspeptin, its less promising peptide counterpart), men must still use it off-label. Why is PT-141 not available at the chemist for men when it is recognised as safe and effective for women? 

PT-141 stimulates the activity of neuro chemicals called melacortins, which have a variety of roles in our brains, including switching on skin pigmentation, appetite and sexual arousal. Studies, albeit small scale, have found that PT-141 can be beneficial to male patients with erectile dysfunction (ED) who do not respond to Sildenafil (Viagra). A 2003 phase 1 randomized double-blind placebo-controlled trial involving 24 healthy male subjects without erectile dysfunction found that test subjects who received doses of PT-141 (4 to 20 mg) by nasal spray experienced “significantly increased duration of rigid erections of 140 minutes compared to 22 minutes in the placebo group”1.   

Based on the above results, the safety and efficacy of PT-141 in test subjects with mild to moderate ED were investigated in a phase 2 study. Results showed a threefold increase in erectile activity following 20mg intranasal administration of PT-1412. A 2008 study involving intranasal bremelanotide spray found that it could help men achieve an erection suitable for penetrative sex when administered 45 minutes prior to intercourse3.  

These findings indicate that PT-141 can act as an alternative ED treatment for subjects who do not respond to Viagra. It is extremely common for men whose erectile dysfunction is caused by psychological issues, particularly anxiety, to find that Viagra does not work for them. The reason is that Viagra is a vasodilator – it acts on the smooth muscle in the groin and penis to encourage blood flow. Viagra has no impact on our brains at all – other than a secondary impact of feeling more horny because we have a better erection. PT-141, however, stimulates our brains and makes us feel more aroused and sexual. This appears to overcome the anxiety men may feel around sex and erections. Given that menopausal women have found Vylessi helps their sex drive, it is fair to assume that older men who feel their libido is waning may also benefit from Bremelanotide boost.  

However, further research remains to be done on PT-141. Consensus seems to be that PT-141 will give you a good erection in around 45 minutes and that the effect lasts up to 8 hours, but patient experience can vary. And, as any man who has taken Viagra knows, timing is all important. There is also considerable debate about what dosage works best. Taking too much could give you an uncomfortable prolonged erection. Then there’s the side effects, of which nausea is the most common and unwelcome if you are planning to have sex in the next hour. So you may need to experiment with the dosage before setting your sexual expectations. Also, taking PT-141 too often can lead to changes in skin pigmentation, as it also stimulates tanning. It can also lead to blood pressure spikes and might not be advised for anyone with kidney and liver problems. On top of that, there is still debate on whether the drug is better delivered as a nasal spray or as a simple injection.  

For practical professional advice on all of the above, there is plenty of guidance online. I would recommend the Kiwi Sex Doctor’s concise and informative videos: Bremelanotid: A cure for ED?, and How to Use Bremelanotide

However, the main reason why PT-141 is not yet licensed for erectile dysfunction treatment is commercial. The market for PDE-5 inhibitors like Viagra and Cialis is huge – because most cases of ED respond well to medications that increase blood flow. The male market for PT-141 is men for whom these drugs don’t work – men with anxiety-based ED or low libido due to age – and that means smaller sales volumes. Palatin Technologies who own the patent to PT-141 (hence the PT) is a relatively a small drug company. Given that there have been fewer treatments available for female low desire, the commercial prospects and the retail price looked much better for Vyleesi. 

For now, most men are going to have to wait for PT-141 over the counter. Bremelanotide is not approved to treat male sexual dysfunction, and the available product online is generally for educational or scientific research only.  However, the consensus is that this peptide is safe and effective. At this point, it is also relatively cheap compared to Vylessi. If you do want to try it, do plenty of research first and remember it’s at your own risk.  

Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Ann N Y Acad Sci. 2003 Jun;994:96-102. doi: 10.1111/j.1749-6632.2003.tb03167.x. PMID: 12851303. 

Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB. Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. Int J Impot Res. 2004 Feb;16(1):51-9. doi: 10.1038/sj.ijir.3901139. PMID: 14963471. 

Safarinejad MR, Hosseini SY. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. J Urol. 2008 Mar;179(3):1066-71. doi: 10.1016/j.juro.2007.10.063. Epub 2008 Jan 18. PMID: 18206919. 

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