Claims for Patent: 11,590,209

Summary for Patent: 11,590,209

Title:	Use of bremelanotide in patients with controlled hypertension
Abstract:	The present invention relates to formulations and methods for treatment of sexual dysfunction in females diagnosed with both sexual dysfunction and controlled hypertension.
Inventor(s):	Julie Krop, Laura Ann Williams
Assignee:	Cosette Pharmaceuticals Inc
Application Number:	US17/154,593
Patent Claims:	1. A method for treating female sexual dysfunction in a female patient diagnosed with both female sexual dysfunction and controlled hypertension, said method comprising administering more than a single subcutaneous injection of a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide to the female patient, when the patient is anticipating sexual activity, wherein the composition comprises 1.00 mg to 1.75 mg net peptide weight of bremelanotide, and wherein there is at least 24 hours between each injection, and no more than eight injections are administered in a month, thereby treating female sexual dysfunction. 2. A method for treating female sexual dysfunction in a female patient diagnosed with both female sexual dysfunction and controlled hypertension, said method comprising administering more than a single subcutaneous injection of a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide to the female patient, when the patient is anticipating sexual activity, the composition comprising an amount of bremelanotide sufficient to result in a peak plasma concentration of bremelanotide of no more than 120 ng/mL within 60 minutes after administration of the composition, and wherein there is at least 24 hours between each injection, and no more than eight injections are administered in a month, thereby treating female sexual dysfunction. 3. A method for treating female sexual dysfunction in a female patient diagnosed with both female sexual dysfunction and controlled hypertension, said method comprising administering more than a single subcutaneous injection of a composition comprising bremelanotide or a pharmaceutically acceptable salt of bremelanotide to the female patient, when the patient is anticipating sexual activity, the composition comprising an amount of bremelanotide sufficient to result in a peak plasma concentration of bremelanotide of no more than 120 ng/mL within 60 minutes after administration of the composition, wherein the composition comprises 1.00 mg to 1.75 mg net peptide weight of bremelanotide, and wherein there is at least 24 hours between each injection, and no more than eight injections are administered in a month, thereby treating female sexual dysfunction. 4. The method of claim 3, wherein the peak plasma concentration of bremelanotide is no more than 100 ng/mL within 60 minutes after administration of the composition. 5. The method of claim 3, wherein the composition comprises 1.75 mg net peptide weight of bremelanotide. 6. The method of claim 3, wherein the composition is an aqueous solution comprising an acetate salt of bremelanotide. 7. The method of claim 6, 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 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 3, wherein the variability in peak plasma concentration within 60 minutes after subcutaneous administration of the composition is a percent coefficient of variation (% CV) less than 30. 11. The method of claim 3, wherein the female sexual dysfunction is decreased sexual desire. 12. The method of claim 3, wherein the female sexual dysfunction is hypoactive sexual desire disorder. 13. The method of claim 3, wherein the female sexual dysfunction is hypoactive sexual desire disorder with female sexual arousal disorder. 14. The method of claim 3, wherein the female sexual dysfunction is hypoactive sexual desire disorder without female sexual arousal disorder. 15. The method of claim 3, wherein the composition is an aqueous solution comprising an acetate salt of bremelanotide and glycerin. 16. The method of claim 15, wherein the composition comprises 2.5% glycerin (w/v). 17. The method of claim 3, wherein the patient is concurrently taking no more than two anti-hypertensive drugs.