PT-141, also known as bremelanotide, is a synthetic peptide that was first developed in the 1990s by Palatin Technologies. It was originally developed as a potential treatment for obesity, but it was later discovered to have aphrodisiac properties.
Palatin Technologies began clinical trials of PT-141 for the treatment of female sexual dysfunction in 1998. The results of these trials were promising, and Palatin Technologies filed a New Drug Application (NDA) with the FDA in 2007. However, the FDA rejected the NDA in 2008 due to concerns about safety, including the risk of hypotension and syncope.
Palatin Technologies continued to develop PT-141, and they initiated a new clinical trial of PT-141 for the treatment of female sexual dysfunction in 2012. The results of this trial were also promising, and Palatin Technologies refiled the NDA with the FDA in 2014. The FDA approved the NDA in 2019, and PT-141 was approved for the treatment of female hypoactive sexual desire disorder (HSDD) under the brand name Vyleesi.
In addition to female HSDD, PT-141 is also being investigated for the treatment of erectile dysfunction (ED) in men, premature ejaculation (PE) in men, and sexual dysfunction associated with spinal cord injury (SCI).
PT-141 is a unique drug because it is the first drug to be approved by the FDA for the treatment of female sexual dysfunction that is not a hormone replacement therapy (HRT). HRT drugs can have side effects, such as increased risk of blood clots and cancer, so PT-141 is a valuable new option for women with sexual dysfunction.
PT-141 is a promising new treatment for sexual dysfunction in both men and women. However, more research is needed to confirm the long-term safety and efficacy of PT-141.
Here are some of the key milestones in the history of PT-141:
- 1990s: PT-141 is developed by Palatin Technologies.
- 1998: Palatin Technologies begins clinical trials of PT-141 for the treatment of female sexual dysfunction.
- 2007: Palatin Technologies files an NDA with the FDA for PT-141.
- 2008: The FDA rejects the NDA for PT-141 due to concerns about safety.
- 2012: Palatin Technologies initiates a new clinical trial of PT-141 for the treatment of female sexual dysfunction.
- 2014: Palatin Technologies refiles the NDA with the FDA for PT-141.
- 2019: The FDA approves PT-141 for the treatment of female HSDD under the brand name Vyleesi.
PT-141 is still in the early stages of development, but it has the potential to be a valuable new treatment for sexual dysfunction in both men and women.
