Vyleesi vs Addyi: What is the difference?
Medically reviewed by Drugs.com. Last updated on Jun 25, 2019.
Vyleesi (bremelanotide) and Addyi (flibanserin) are drugs used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Vyleesi is an injection, which is self-administered as required, and Addyi is an oral tablet, taken once daily, every day at bedtime.
|Company||AMAG Pharmaceuticals, Inc.||Sprout Pharmaceuticals, Inc.|
|Date of Approval||June 21, 2019||August 15, 2015|
|Mechanism of Action||melanocortin receptor agonist||5-HT1A agonist & 5-HT2A antagonist|
|Administration||Vyleesi is self-administered via subcutaneous injection under the skin of the abdomen or thigh using a single use autoinjector pen. It is used as needed, at least 45 minutes before anticipated sexual activity.||Addyi is an oral tablet taken once daily, every day, only at bedtime. Addyi must be taken at bedtime to reduce the risk of low blood pressure, fainting (loss of consciousness), accidental injury, and sleepiness.|
|Limitations||Discontinue treatment after 8 weeks if there is no improvement in symptoms. Use no more than one dose in 24 hours, or eight doses in a month.||Discontinue treatment after 8 weeks if there is no improvement in symptoms.|
|Warnings||Based on the manufacturer's data, there does not appear to be an interaction between Vyleesi and alcohol. Vyleesi however may significantly decrease the blood levels of naltrexone in patients who take a naltrexone-containing medication by mouth to treat alcohol or opioid dependence. Patients who take oral naltrexone should not use Vyleesi because it could lead to naltrexone treatment failure.||When Addyi was first approved, patients were warned to completely abstain from drinking alcohol due to the increased risk of severe low blood pressure and fainting. In April 2019, the FDA ordered changes to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi, but that it does not have to be avoided completely.|
|Does it work?||In clinical trials, about 25 percent of women treated with Vyleesi had an increase in their sexual desire score, compared to about 17 percent of those who took a placebo.||In clinical trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress.|
|Side Effects||The most common side effects (incidence > 4%) reported during clinical trials were nausea, flushing, injection site reactions, headache, and vomiting. Nausea was reported in 40% of patients, often within an hour of dosing, and 13% of those patients reported having nausea bad enough to necessitate anti-nausea medications. The other side effect of note was gum and skin darkening, particularly in the face and the breasts, which was experienced by about 1% of patients.||
The most common side effects (incidence ≥2%) reported during clinical trials were dizziness, somnolence, nausea,
fatigue, insomnia, and dry mouth. Addyi can cause severe hypotension (low blood pressure) and syncope (loss of consciousness) when taken with alcohol, or medicines known as moderate or strong CYP3A4 inhibitors that interfere with the breakdown of Addyi in the body.