Peptides have been making headlines recently amid discussions about regulatory changes, compounding eligibility, and research-only peptides sold through questionable online sources. This has created the impression that all peptides fall into the same category when they do not. In reality, peptides are a large and diverse class of therapeutic molecules, some of which are FDA-approved and have become established treatments for a variety of medical conditions, including diabetes, obesity, and sexual health.
One example is PT-141 (bremelanotide). Unlike many peptides currently being discussed online, PT-141 was FDA-approved as Vyleesi® in 2019 to treat patients experiencing low sexual desire and is supported by clinical trials and has established pharmacology and prescribing information.
What Is PT-141?
PT-141 (bremelanotide) is a synthetic peptide derived from α-melanocyte-stimulating hormone. It is FDA-approved to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and has also been investigated for improving sexual desire and erectile function in men.
Side Effects
Like any medication, PT-141 does have possible side effects, with the most common ones being nausea, flushing, headache, injection-site reactions, and temporary increases in blood pressure accompanied by decreases in heart rate.
Administration Routes
The only FDA-approved formulation of bremelanotide (Vyleesi®) is a subcutaneous injection administered using a prefilled autoinjector. PT-141 was originally developed as an intranasal spray. Early clinical studies in both men and women demonstrated improvements in sexual desire, arousal, and erectile function using intranasal formulations.
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FDA-Approved Use for Women
The FDA approved bremelanotide for treating acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by persistently low sexual desire that causes significant personal distress and cannot be explained by another medical condition or medication. The drug can be administered as a subcutaneous injection or as a nasal spray as needed before sexual activity.
Clinical trials demonstrated improvements in sexual desire while reducing distress associated with low libido.1 Long-term extension studies also showed that many women maintained these improvements with continued therapy.2
Off-Label Use for Men
Although PT-141 is only FDA-approved for HSDD in premenopausal women, it is also prescribed off-label for men who don’t respond well to conventional erectile dysfunction medications.
PT-141 vs. Other Erectile Dysfunction Medications
Unlike medications such as sildenafil and tadalafil, which primarily increase blood flow, PT-141 activates melanocortin receptors within the central nervous system. It influences the neural pathways involved in sexual desire and arousal. This means that, instead of simply improving the physiological ability to achieve an erection, it targets sexual desire and arousal and may be prescribed off-label for men with low libido. It can also be prescribed in men whose erectile dysfunction has a psychogenic component rather than being purely vascular.3 A small early study even suggested that PT-141 can be combined with sildenafil to enhance the erectile response compared with sildenafil alone.4
The Role of Compounding Pharmacies in Dispensing PT-141
Interest in peptide therapies continues to grow, and more peptides are receiving FDA approval each year. For sexual health, peptide-based therapies like PT-141 are expanding available treatment options, particularly for patients whose needs are not met by commercially available medications.
Although PT-141 is commercially available only as a subcutaneous autoinjector, some patients may prefer an alternative route of administration. In these cases, a compounding pharmacy, such as VLS Pharmacy, works closely with prescribers to prepare patient-specific formulations that follow our rigorous safety and quality standards and applicable regulatory requirements.
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Reach out to our team if you have specific questions about our new automated compounding system and compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
References
- Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500
- Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019;134(5):909-917. doi:10.1097/AOG.0000000000003514
- Kim S, Cho MC, Cho SY, Chung H, Rajasekaran MR. Novel Emerging Therapies for Erectile Dysfunction. World J Mens Health. 2021;39(1):48-64. doi:10.5534/wjmh.200007
- Diamond LE, Earle DC, Garcia WD, Spana C. Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response. Urology. 2005;65(4):755-759. doi:10.1016/j.urology.2004.10.060
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