Drug Insights

Is Bremelanotide approved by the FDA?

21 June 2024
3 min read

Yes, bremelanotide, marketed under the brand name Vyleesi, is FDA approved. The FDA granted approval for bremelanotide on June 21, 2019. This medication is specifically indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

What is Bremelanotide?

Bremelanotide is a medication used to address low sexual desire in women who have not gone through menopause and do not have low sexual desire due to other causes such as relationship issues, health problems, mental illness, or the use of certain medications. It belongs to the drug class known as melanocortin receptor agonists.

How is Bremelanotide Administered?

Bremelanotide is available as a subcutaneous injection, typically administered at a dosage of 1.75 mg. The injection should be given at least 45 minutes before anticipated sexual activity. The use of bremelanotide should not exceed one dose within a 24-hour period or eight doses within a month.

Common Side Effects

The use of bremelanotide can lead to several side effects. Common ones include:

  • Nausea and vomiting
  • Flushing
  • Headache, tiredness, dizziness
  • Cough, stuffy nose
  • Reactions at the injection site such as pain, bruising, redness, itching, or bleeding

Serious side effects may also occur, such as severe nausea, slow heartbeats, and high blood pressure. Patients should seek medical attention if these occur.

Precautions and Warnings

Bremelanotide should not be used by individuals with certain medical conditions, including heart disease or uncontrolled high blood pressure. It is also not recommended for use by postmenopausal women or men, and it is not intended to enhance sexual performance.

Women using bremelanotide should use effective birth control to prevent pregnancy, as the medication can harm an unborn baby. Additionally, it is advised to avoid breastfeeding while using this medication.

Drug Interactions

Bremelanotide can interact with other medications, potentially affecting how the body absorbs drugs taken orally. Patients should inform their healthcare providers about all medications they are currently taking, including prescription, over-the-counter, vitamins, and herbal products.

Conclusion

Bremelanotide (Vyleesi) was approved by the FDA on June 21, 2019, for treating acquired, generalized HSDD in premenopausal women. This medication offers a new option for women experiencing distressing low sexual desire, provided it is not related to other medical, psychological, or relational issues. As with any medication, it is crucial to follow the prescribed guidelines and consult healthcare providers for any concerns or adverse effects.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

Subcutaneous Amivantamab BLA Submitted to U.S. FDA for EGFR-Mutant Non-Small Cell Lung Cancer
Latest Hotspot
3 min read
Subcutaneous Amivantamab BLA Submitted to U.S. FDA for EGFR-Mutant Non-Small Cell Lung Cancer
21 June 2024
A Biologics License Application for subcutaneous amivantamab was submitted to the U.S. FDA for people with non-small cell lung cancer with EGFR mutations.
Read →
Eli Lilly: GLP-1R/GCGR/GIPR Triagonist Reduces Liver Fat Content by 86%
Hot Spotlight
5 min read
Eli Lilly: GLP-1R/GCGR/GIPR Triagonist Reduces Liver Fat Content by 86%
20 June 2024
The study indicated that Retatrutide (LY3437943), a GLP-1R-related triple receptor agonist currently under clinical development, demonstrated significant efficacy and favorable safety in the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD).
Read →
Pharma Frontiers: Daily Digest of Global Pharmaceutical News - Jun 20
Pharma Frontiers
10 min read
Pharma Frontiers: Daily Digest of Global Pharmaceutical News - Jun 20
20 June 2024
Jun 20th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.
Read →
Takeda Releases Phase 3 Topline Data for Soticlestat (TAK-935) in Dravet and Lennox-Gastaut Syndromes
Latest Hotspot
3 min read
Takeda Releases Phase 3 Topline Data for Soticlestat (TAK-935) in Dravet and Lennox-Gastaut Syndromes
19 June 2024
The SKYLINE trial was a multicenter, randomized, and double-blind Phase 3 study that assessed the combination of soticlestat (TAK-935) with standard care against a placebo with standard care in patients suffering from refractory Dravet syndrome.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.