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 diagnosed with female sexual dysfunction and anticipating sexual activity, the method comprising administering to the female patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, thereby treating female sexual dysfunction while reducing or minimizing side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt 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 administering results in improved overall sexual function as measured by a Female Sexual Function Index total score improvement of 3 or greater.
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 between 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 5.0, and wherein the composition further comprises one or more agents to adjust pH.
9 . The method of claim 8 , wherein the one or more agents to adjust pH are selected from the group consisting of hydrochloric acid and sodium hydroxide.
10 . The method of claim 4 , wherein the female patient is premenopausal.
11 . The method of claim 4 , wherein the female patient is postmenopausal.
12 . The method of claim 4 , wherein the 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 salt of bremelanotide.
13 . The method of claim 12 , wherein the variability in peak plasma concentration within 60 minutes after intranasal administration is a % CV greater than 30.
14 . The method of claim 4 , wherein the peak plasma concentration of bremelanotide is at least 60 ng/mL.
15 . The method of claim 4 , wherein the female sexual dysfunction comprises is hypoactive sexual desire disorder.
16 . The method of claim 4 , wherein the female sexual dysfunction is decreased sexual desire.
17 . The method of claim 4 , wherein the composition comprises between 1.25 mg and 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide.
18 . The method of claim 4 , wherein the side effects comprise one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, and hypertension.
19 . A method for treating female sexual dysfunction in a female patient diagnosed with female sexual dysfunction and anticipating sexual activity, the method comprising administering to the female patient by subcutaneous injection a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide, thereby treating female sexual dysfunction while reducing or minimizing side effects compared to intranasal administration of an equivalent dosage of bremelanotide or a pharmaceutically acceptable salt 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 administering results in reduced distress related to sexual dysfunction as measured by a reduction in a Female Sexual Distress Scale-DAO total score improvement of about 11.1.
20 . The method of claim 19 , wherein the 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 salt of bremelanotide.
21 . The method of claim 20 , wherein the composition is an aqueous solution comprising an acetate salt of bremelanotide and glycerin.
22 . The method of claim 20 , wherein the composition comprises between 1.25 mg and 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide.
23 . The method of claim 19 , wherein the side effects comprise one or more of nausea, flushing, headache, changes in systolic blood pressure, changes in diastolic blood pressure, changes in heart rate, vomiting, and hypertension.