DOC.05 // REFS

References

Cited sources, in order of first appearance, with DOIs and PubMed / FDA / ACOG / HHS links.

How to use this list

Citations are numbered in order of first appearance across the manual. Bracketed identifiers '[01]', '[02]', and so on in the body text refer to the entries below. Primary sources are linked directly to PubMed, PMC, the FDA's DailyMed or accessdata catalogs, the American College of Obstetricians and Gynecologists, the HHS Telehealth office, or the publishing journal. Where a DOI exists it is given; where the source is a regulatory document or press release the canonical URL is given instead.

The list below is the full record. Each entry pairs a research finding or regulatory framework cited in the manual with its underlying source.

  1. Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics & Gynecology. 2019.
  2. Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstetrics & Gynecology. 2019.
  3. Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of Women's Health. 2022.
  4. Simon JA, Kingsberg SA, Portman D, Jordan R, Lucas J, Sadiq A, Krop J, Clayton AH. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. Journal of Women's Health (Larchmt). 2022.
  5. Shadiack AM, Sharma SD, Earle DC, Spana C, Hallam TJ. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. Journal of Hypertension. 2017.
  6. U.S. Food and Drug Administration / Palatin Technologies / AMAG Pharmaceuticals. Bremelanotide Injection Prescribing Information. DailyMed / FDA Label. 2019.
  7. U.S. Food and Drug Administration / Palatin Technologies. Bremelanotide Injection Prescribing Information — Section 7 Drug Interactions. FDA / DailyMed. 2019.
  8. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Bremelanotide — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. LiverTox, NIH/NCBI Bookshelf. 2022.
  9. Pfaus JG, Sadiq A, Spana C, Clayton AH. The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. CNS Spectrums. 2022.
  10. U.S. Food and Drug Administration / Palatin Technologies. Bremelanotide Injection Full Prescribing Information — Section 12.3 Clinical Pharmacology. accessdata.fda.gov. 2019.
  11. Palatin Technologies. Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide (BMT-801). Palatin Technologies press release. 2025.
  12. Rowen TS, Abdo C, el Kak F, Maseroli E, Pope R, Prasad P, Velten J, Vignozzi L. Evaluation and management of hypoactive sexual desire disorder in women. Recommendations from the 5th International Consultation on Sexual Medicine (ICSM 2024). Sexual Medicine Reviews. 2025.
  13. Edinoff AN, Sanders NM, Lewis KB, Apgar TL, Cornett EM, Kaye AM, Kaye AD. Bremelanotide for Treatment of Female Hypoactive Sexual Desire. Neurology International. 2022.
  14. Kingsberg SA, Althof SE, Clayton AH, Kroll R, Goldstein I, Krop J, Spana C, Lucas J, Jordan R, Portman DJ. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. Sexual Medicine. 2019.
  15. Dooley AB, de la Houssaye N, Baum N. Use of Telemedicine for Sexual Medicine Patients. Sexual Medicine Reviews. 2020.
  16. Rabinowitz MJ, Kohn TP, Ellimoottil C, Alam R, Liu JL, Herati AS. The Impact of Telemedicine on Sexual Medicine at a Major Academic Center During the COVID-19 Pandemic. Sexual Medicine. 2021.
  17. Tan RKJ, Hensel D, Ivanova O, Gomez Bravo R, Olumide A, Adebayo E, Cleeve A, Gesselman A, Shah SJ, Adesoba H, Marley G, Tang W. Telemedicine Use During the COVID-19 Pandemic in 8 Countries From the International Sexual Health and Reproductive Health Consortium: Web-Based Cross-Sectional Survey Study. Journal of Medical Internet Research. 2025.
  18. American College of Obstetricians and Gynecologists Committee on Ethics. ACOG Committee Statement No. 20: Ethical Considerations With Telehealth in Obstetrics and Gynecology. Obstetrics & Gynecology. 2025.
  19. U.S. Department of Health and Human Services. Prescribing controlled substances via telehealth (with discussion of non-controlled prescribing baseline). Telehealth.HHS.gov. 2025.
  20. Borland JM, Kohut-Jackson AL, Peyla AC, Hall MAL, Mermelstein PG, Meisel RL. Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder. Neuropharmacology. 2025.
  21. Suzuki S, Kitanaka C, Okada M. Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells via Suppression of Survivin Expression. Anticancer Research. 2024.
  22. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides. 2006.
  23. Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Ann N Y Acad Sci. 2003.
  24. Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clin Ther. 2017.
  25. Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical toxicology (Philadelphia, Pa.). 2012.
  26. Bardhan M, Anand A, Javed A, Chilo MA, Khan N, Garg T. Polymorphism of Melanocortin Receptor Genes-Association with Inflammatory Traits and Diseases. Diseases (Basel, Switzerland). 2025.
  27. Al Shaer D, Al Musaimi O, Albericio F, de la Torre BG. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals (Basel, Switzerland). 2020.
  28. Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019.
  29. Mestria S, Odoardi S, Frison G, Strano Rossi S. LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs. Drug testing and analysis. 2021.
  30. Hedlund P. PT-141 Palatin. Current opinion in investigational drugs (London, England : 2000). 2004.
  31. Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes Obes Metab. 2022.