Bremelanotide, a chemical compound created in the laboratory, targets the brain’s hypothalamus and rejiggers brain chemistry to improve sexual response.
Originally touted as a promising potential treatment for female sexual dysfunction, bremelanotide may also help to improve sexual arousal in men who fail to respond to PDE5 inhibitors, such as Viagra and Cialis. While the latter temporarily improve blood flow to the penis, bremelanotide works on brain chemistry to stimulate sexual desire.
The synthetic compound’s developer is Palatin Technologies Inc., a New Jersey-based biopharmaceuticals company. In early 2017, Palatin successfully completed two Phase 3 studies of bremelanotide as a treatment for female sexual dysfunction. Shortly thereafter, Palatin signed a licensing agreement granting AMAG Pharmaceuticals exclusive North American commercial rights to bremelanotide, which would be sold under the brand name Rekynda.
Could Go on Sale in 2019
At the time the licensing agreement was signed, AMAG announced that it hoped to file a new drug application, or NDA, for bremelanotide with the FDA sometime in early 2018. As this is written, no such NDA has yet been filed. AMAG also indicated that it hoped to get speedy FDA approval for bremelanotide as a treatment for hypoactive sexual desire disorder (HSDD) in women, allowing it to bring the product to market by early 2019.
Of the licensing agreement, William Heiden, chief executive officer of AMAG, said his company was pleased to further serve the health needs of women through the addition of Rekynda to its product line. “With our deep relationships in the women’s health community and experience building educational programs that engage patients and healthcare professionals, AMAG is well suited to drive awareness and increased understanding of HSDD,” he added.
No Testing Among Men Yet
While clinical testing of bremelanotide has been limited to female study participants, the drug’s effects on brain chemistry would seem to indicate it could fire up the male libido as well, something that the PDE5 inhibitors cannot do.
In the double-blind, placebo-controlled clinical trials of bremelanotide, female study participants were randomly selected to receive either a 1.75 milligram dose of bremelanotide delivered by auto-injector pen or a placebo. Those who received the active drug reportedly reached or surpassed the study’s pre-established endpoints in terms of improvement in sexual desire and decreased distress associated with low sexual desire.
Side Effects Generally Mild
In both Phase 2 and Phase 3 clinical trials, adverse side effects included flushing, headache, and nausea, categorized as mild to moderate in intensity. Interestingly, after the completion of the trials and 24-week evaluation period, female study participants were given the option of continuing an open-label safety extension study for an additional 12 months. Almost 80 percent of the study subjects chose to remain in the open-label portion of the study, which allows participants to know which treatment they are getting.
While bremelanotide has not yet been tested on men in clinical trials, it has been subjected to animal testing on both male and female rats. According to a report posted at TheIronDen.com, male rats responded positively to the drug at even lower doses than was needed to increase sexual desire in female rats.
While animal tests indicate that bremelanotide could eventually help treat male sexual dysfunction, it’s unlikely to come to market until 2019 or later. In the meantime, men who find that Viagra or one of the other oral ED medications helps them to overcome their symptoms of impotence will have to rely on these medications to meet their needs. If the convenience of online ordering appeals to you, consider using the services of eDrugstore.com, a longtime online facilitator based in the United States. To learn more about its services, or to start your order for Viagra or other prescription ED medications, visit eDrugstore.com.
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