Alpha Now demystifies the new sexual arousal drug bremelanotide and explains how it might impact your treatment for erectile dysfunction in the future. Keep reading to find out more.
High Tide for Bremelanotide: The New ED Wonder Drug
What Is Bremelanotide and What Does It Mean for ED?
Bremelanotide promises a new way of inducing erections compared to Sildenafil and Tadalafil. Instead of inhibiting the enzyme which signals the end of an erection, bremelanotide works by enhancing the primal mating state in humans signaled by lordosis.
Lordosis Definition: AKA mammalian lordosis; the posture of animals signaling they are ready for mating
The drug is also called Vyleesi, and its mechanism of action involves the nervous system instead of the circulatory or blood flow system for arousal. It acts directly on the brain.
A Short History of Bremelanotide
Discovery of Melanocortin Receptor Agonist
Scientists in the 1960s discovered a melanocyte-stimulating hormone (MSH) which aroused rats for mating. Two decades later, a team working in a laboratory at the University of Arizona synthesized MSH into Melanotan I and Melanotan II.
The team experimented on Melanotan I and II to develop sunless tanning products. Mac Hadley, a team member who worked on Melanotan II, injected himself with the agent and reported having an erection lasting 8 hours long with bouts of nausea.
Early Clinical Trials and Patient-Reported Outcome
The University of Arizona team lodged their patents to a tech transfer company called Competitive Technologies. Competitive Technologies licensed Melanotan to Palatin Technologies.
Palatin Technologies ceased working on Melanotan and isolated bremelanotide from the formulation. By 2005, they developed a bremelanotide nasal spray for the use of men and women.
They undertook two batches of clinical trials for their nasal spray around 2005 and continued until 2007. Throughout the testing period, the men and women from the sampling pool reported an increase in sexual desire and the ability to complete three rounds of sexual intercourse in the space of four hours on a single dose.
The FDA Bans Bremelanotide
By the time Palatin Technologies completed its second trial of the intranasal bremelanotide spray, the Food and Drugs Administration (FDA) chose to ban the product from releasing. Bremelanotide or the PT 141 nasal spray caused an increase in blood pressure among its subjects which lasted for 12 hours before easing.
The FDA banned the product despite promising results in curbing hypoactive sexual desire disorder in women and erectile dysfunction in men.
New Clinical Trials and FDA Approval
Palatin Technologies recalibrated bremelanotide and turned it into an injectable medication. The company went to develop the medication with AMAG Pharmaceuticals with fees up to $60 million.
RELATED: What To Do When Viagra Doesn’t Work
Phase 4 Bremelanotide Clinical Trials and FDA Approval
By the end of 2014, Palatin Technologies began trials for bremelanotide but changed the delivery mechanism to auto-injection. It’s the same delivery method diabetes patients use with insulin.
In June 2018, the companies made another FDA application but for hypoactive sexual desire disorder medicine for women. The FDA approved bremelanotide for this purpose and Palatin Technologies has started marketing the drug as Vyleesi for the exclusive use of women.
How to Use Vyleesi
For best effect, patients should inject Vyleesi around 45 minutes before they begin sexual intercourse with their partners.
The Vyleesi website warns users to inject only a single dose of Vyleesi within 24 hours to avoid adverse side effects. Palatin Technologies also warns users to limit Vyleesi injections to 8 doses a month.
Bremelanotide Side Effects
While bremelanotide carries huge potential in the treatment of erectile dysfunction and hypoactive sexual disorder, it still has side effects just like other aphrodisiac-like drugs such as Viagra.
When taking Vyleesi, the manufacturer warns patients to expect possible nausea. The FDA also notes at least 1% of patients might encounter blackening around the subcutaneous injection site; though this usually results only because of prolonged use of the same site.
Bremelanotide tends to increase the systolic and diastolic blood pressure of patients. It’s for this reason the FDA banned the drug during the first clinical trials.
People with kidney problems and liver disease should stay off Vyleesi since the rapid circulation of blood can degrade kidney and liver function.
Since the drug works with the central nervous system, doctors still need to clarify how Vyleesi will affect the development of unborn children. Palatin Technologies advises against using their product during pregnancy.
Bremelanotide, aka Vyleesi, gives hope to erectile dysfunction and sexual dysfunction sufferers. Although Vyleesi has entered the market, we advise men to keep their treatment options open until experts rule the medication 100% safe to use.
What do you think of bremelanotide? Would you use it for yourself? Give us your answers in the comments section below.