JUN 23, 2019 8:32 AM PDT

FDA Approves Vyleesi - "The Female Viagra" for Premenopausal Women

WRITTEN BY: Tiffany Dazet

Last Friday, the FDA approved a new drug that some are referring to as “the female Viagra.” Vyleesi, the drug’s market name, is injectable bremelanotide intended to restore natural sexual desire in premenopausal women suffering from hypoactive sexual desire disorder (HSDD). Vyleesi is the second FDA-approved treatment for female HSDD. Addyi, the other drug approved for HSDD in 2015, is a pill that must be taken daily and restricts alcohol use, whereas Vyleesi is administered as needed and does not restrict alcohol use.

According to AMAG Pharmaceuticals, the U.S. sponsor of the drug, approximately six million premenopausal women in the United States suffer from HSDD. The FDA defines HSDD as “low sexual desire that causes marked distress or interpersonal difficulty.” Underlying medical or psychiatric conditions, relationship problems, or other drug substances do not cause HSDD. In a statement from the FDA, Dr. Hylton V. Joffe—director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic products—stated “there are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment.”

Vyleesi operates by activating melanocortin receptors, a brain-stimulating hormone associated with sexual arousal in both men and women. The medication is injected under abdomen or thigh skin 45-minutes before sexual activity. Patients are instructed only to use one dose within 24 hours, and no more than eight doses per month.

Two 24-week safety and effectiveness trials included 1,247 premenopausal women with generalized HSDD. Common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. In clinical trials, approximately 40% of participants experienced nausea. Because Vyleesi increases blood pressure after injecting, patients with high blood pressure or cardiovascular disease are warned not to use the drug.

AMAG Pharmaceuticals estimates that Vyleesi will be available in September through select pharmacies. Prior to the FDA’s approval, AMAG launched a campaign to increase awareness and end stigma about female HSDD. The key message of this campaign—called “unblush”—is that “HSDD can be caused by an imbalance of certain hormones and neurotransmitters in the brain, a surmise drawn from functional MRI scans of women with varying levels of sexual desire. If the basis of the condition is physiological, so too may be the fix.”

Sources: FDA, AMAG, LA Times, Photo via AP News

Resources: Queen V - Livin' Libido Loca

About the Author
  • Tiffany grew up in Southern California, where she attended San Diego State University. She graduated with a degree in Biology with a marine emphasis, thanks to her love of the ocean and wildlife. With 13 years of science writing under her belt, she now works as a freelance writer in the Pacific Northwest.
You May Also Like
AUG 26, 2021
Health & Medicine
Hoover Dam is going dry: Water shortage declared for the first time ever in the USA
AUG 26, 2021
Hoover Dam is going dry: Water shortage declared for the first time ever in the USA
We have all heard of the famous “bathtub ring” around Lake Mead (AZ, MN) and many have seen photos and video ...
AUG 26, 2021
Microbiology
Some Herbal Medicines May Help Treat Tick-Borne Diseases
AUG 26, 2021
Some Herbal Medicines May Help Treat Tick-Borne Diseases
Ticks are vectors for disease; they can transmit pathogenic bacteria to animals and humans through their bites. Diseases ...
AUG 28, 2021
Cannabis Sciences
Could Eye-tracking Data Detect THC Levels?
AUG 28, 2021
Could Eye-tracking Data Detect THC Levels?
Eye-tracking data shows promise for detecting levels of tetrahydrocannabinol (THC). The corresponding study was publishe ...
SEP 07, 2021
Health & Medicine
Think you can pay back your sleep debt this weekend? Think again.
SEP 07, 2021
Think you can pay back your sleep debt this weekend? Think again.
Researchers find that even one night of sleep loss results in impaired functioning and well being.
SEP 16, 2021
Cannabis Sciences
Cannabis Use and Exercise- A Dire Need for High-quality Evidence
SEP 16, 2021
Cannabis Use and Exercise- A Dire Need for High-quality Evidence
It should come as no surprise that exercise is good for our health. Regular exercise reduces the risks of serious chroni ...
SEP 17, 2021
Earth & The Environment
City Solutions - Green Rooftops in Urban Spaces
SEP 17, 2021
City Solutions - Green Rooftops in Urban Spaces
Most of the world’s population lives in cities. Population growth is expected to continue to be focused in urban a ...
Loading Comments...