USES OF BREMELANOTIDE IN THERAPY FOR FEMALE SEXUAL DYSFUNCTION
Use of a subcutaneously administered dose of between about 1.25 mg and 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide for the treatment of female sexual dysfunction in women while reducing or minimizing undesirable side effects.
1 .- 3 . (canceled)
4 . A method for treating female sexual dysfunction in a female patient, the method comprising administering to the female patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable sale of bremelanotide, wherein the composition comprises no more than about 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide, and wherein the method reduces or minimizes at least one side effect compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt of bremelanotide.
5 . The method of claim 4 , wherein the composition is an aqueous solution comprising an acetate salt of bremelanotide and glycerin.
6 . The method of claim 5 , wherein the composition comprises 2.5% glycerin (w/v).
7 . The method of claim 5 , wherein the acetate salt of bremelanotide is from 6% and 12% acetic acid (w/w) in an aqueous solution of bremelanotide.
8 . The method of claim 7 , wherein the composition has a pH of about 5.9, and wherein the composition further comprises one or more agents to adjust the pH.
9 . The method of claim 8 , wherein the one or more agents to adjust the pH is hydrochloric acid or sodium hydroxide.
10 . The method of claim 4 , wherein the female patient is premenopausal.
11 . The method of claim 4 , wherein the administering results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater.
12 . The method of claim 4 , wherein a variability in peak plasma concentration within 60 minutes after subcutaneous administration of the composition is less than the variability in peak plasma concentration within 60 minutes after intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable sale of bremelanotide.
13 . The method of claim 12 , wherein the variability in peak plasma concentration within 60 minutes after intranasal administration is a percent coefficient of variation (CV) greater than 30.
14 . The method of claim 12 , wherein the peak plasma concentration of bremelanotide is at least 60 ng/mL.
15 . The method of claim 4 , wherein the female patient is diagnosed with female sexual dysfunction, and wherein the female patient is anticipating sexual activity.
16 . The method of claim 15 , wherein the female sexual dysfunction is hypoactive sexual desire disorder.
17 . The method of claim 4 , wherein the composition comprises from 1.25 mg to 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide.
18 . The method of claim 4 , wherein the at least one side effect is one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, and hypertension.