Muse

Muse^® was a urethral suppository medication containing the active ingredient alprostadil, a prostaglandin E1 (PGE1) analog. It was approved by the U.S. Food and Drug Administration (FDA) to treat erectile dysfunction (ED) but was discontinued in June 2024 and is no longer available in the U.S. No generic versions of the drug are currently available.

Unlike oral PDE5 inhibitors, such as sildenafil (Viagra^®) or tadalafil (Cialis^®), Muse was applied directly into the urethra using a preloaded applicator. It was then absorbed into the surrounding tissue, promoting smooth muscle relaxation and increased blood flow to the penis.

Muse (alprostadil) is indicated:

• For the treatment of erectile dysfunction

Prostaglandin E1 agonist

• The most frequently reported adverse reactions during in-clinic titration included:

  • Pain in the penis (36%)

  • Pain in the urethra (13%)

  • Pain in the testes (5%)

• Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients

• Symptomatic lowering of blood pressure occurred in 3% of patients

• Dizziness was reported in 4% of patients

• Fainting was reported by 0.4% of patients

Muse is no longer sold in the U.S., and there are no generic versions currently available.

• Known hypersensitivity to alprostadil

• Abnormal penile anatomy

• Sickle cell anemia or trait, thrombocythemia, polycythemia, multiple myeloma

• Muse should not be used in men for whom sexual activity is inadvisable

• Muse should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier

• A complete medical history and physical examination should be undertaken to exclude reversible causes of erectile dysfunction prior to the initiation of Muse therapy

• Cardiovascular effects: During in-clinic dosing, patients should be monitored for symptoms of low blood pressure, and the lowest effective dose of Muse should be prescribed

• Hematologic effects: Patients administering Muse may be at risk of urethral abrasion resulting in minor bleeding or spotting

• Resumption of sexual activity: Sexual intercourse is considered a vigorous physical activity, and it increases heart rate as well as cardiac work

• Priapism and prolonged erection: In two identical multi-center, double-blind, placebo-controlled, parallel-group studies, priapism (rigid erection lasting 4 hours or longer) was reported in 2 of 1511 patients (0.13% of patients)

• Patients should be informed that Muse offers no protection from the transmission of sexually transmitted diseases

• Patients should be instructed how to administer Muse

• It is recommended that couples using Muse employ adequate contraception if the female partner is of childbearing potential

• Pregnancy: Muse should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier

• Breastfeeding: Muse is not indicated for use in newborns, children, or women

*This information is from the label for brand name Muse^®. See the Full Prescribing Information for more complete information. Alprostadil, the active ingredient in Muse, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient alprostadil.