- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Review, Journal: Pharmacotherapy of Hypoactive Sexual Desire Disorder in Premenopausal Women. (Pubmed Central) - Jan 15, 2025
Further research with the most suitable clinical endpoints and consideration of patient factors are crucial before widespread adoption of flibanserin and bremelanotide. Pharmacists are encouraged to embrace this opportunity to provide premenopausal HSDD care in ambulatory and community practice settings.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Trial completion: KD-BMT-301: A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) (clinicaltrials.gov) - Nov 12, 2024
P3, N=193, Completed,
Recruiting --> Active, not recruiting | N=60 --> 108 Recruiting --> Completed
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Trial completion: Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder (clinicaltrials.gov) - Aug 9, 2024
P4, N=40, Completed,
Activation of these receptors by bremelanotide may inhibit the expression of survivin, thereby sensitizing glioblastoma cells to cell death. Recruiting --> Completed
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Review, Journal: Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. (Pubmed Central) - Apr 29, 2024
Several other continuous and categorical outcomes generated modest apparent benefits, though nearly all of these outcomes were likely derived post-hoc. Across RECONNECT trial data from two prior publications and the current study, bremelanotide's benefits are statistically modest and limited to outcomes for which scant evidence of validity among women with HSDD exists.
- |||||||||| FDA event, Review, Journal: A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022). (Pubmed Central) - Apr 22, 2024
Across RECONNECT trial data from two prior publications and the current study, bremelanotide's benefits are statistically modest and limited to outcomes for which scant evidence of validity among women with HSDD exists. We found 12 novel psychiatric medications approved by the FDA from 2018 to 2022, representing a very small percentage of the total FDA approvals during that
- |||||||||| Scenesse (afamelanotide) / Clinuvel, Vyleesi (bremelanotide) / Palatin Technologies, Imcivree (setmelanotide) / Rhythm Pharma
Review, Journal: Targeting the central melanocortin system for the treatment of metabolic disorders. (Pubmed Central) - Aug 11, 2023
These approvals have also renewed excitement in the development of therapeutics targeting the melanocortin system. Here, we review the anatomy and function of the melanocortin system, discuss progress and challenges in developing melanocortin receptor-based therapeutics, and outline potential metabolic and behavioural disorders that could be addressed using pharmacological agents targeting these receptors.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Journal: Pharmacologic therapeutic options for sexual dysfunction. (Pubmed Central) - Nov 9, 2022
No abstract available Pharmacologic treatment with local estrogen and testosterone replacement in postmenopausal individuals and with centrally-acting therapies such as flibanserin, bremelanotide, and testosterone in premenopausal individuals assigned female at birth are safe and can be used to improve sexual desire and sexual satisfaction.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Imcivree (setmelanotide) / Rhythm Pharma
Review, Journal: Ligands for Melanocortin Receptors: Beyond Melanocyte-Stimulating Hormones and Adrenocorticotropin. (Pubmed Central) - Oct 28, 2022
Early efforts modifying endogenous ligands resulted in the development of many potent and selective ligands. This review focuses on the ligands for neural MCRs, including classical ligands (MSH and agouti-related peptide), nonclassical ligands (lipocalin 2, β-defensin, small molecules, and pharmacoperones), and clinically approved ligands (ACTH, setmelanotide, bremelanotide, and several repurposed drugs).
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Journal: An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder. (Pubmed Central) - Oct 16, 2022
Although data from clinical trials demonstrated a significant change in validated questionnaires, the overall clinical benefit appears to be modest. However, these results should be interpreted in the light of the dramatic challenges in conducting well-designed clinical trials for female sexual dysfunction, due to the significant placebo effect of pharmacotherapy, and the frequent use of outcome measures that are likely to be highly susceptible to expectation biases, such as long periods of recall of sexual and emotional response.
- |||||||||| Ophena (ospemifene) / Shionogi, Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Review, Journal: Management of Hypertension with Female Sexual Dysfunction. (Pubmed Central) - Jun 5, 2022
To treat FSD in the presence of hypertension, controlling blood pressure is key, and the administration of angiotensin receptor blockers is preferred. In addition to controlling blood pressure, for premenopausal women, flibanserin and bremelanotide can be tried, while ospemifene and hormone supplements are preferred for postmenopausal women.
- |||||||||| Livial (tibolone) / Organon, Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Journal: Female Sexual Dysfunctions: an overview on the available therapeutic interventions. (Pubmed Central) - Jun 4, 2022
The management of FSDs may require multidisciplinary and interdisciplinary approaches. Pharmacological and nonpharmacological interventions appears to have potential as a treatment for FSDs, but there are currently no gold standards regarding recommended treatment modalities, and the duration, frequency, and intensity of therapy sessions.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Enrollment open: KD-BMT-301: A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) (clinicaltrials.gov) - May 17, 2022
P3, N=186, Recruiting,
No abstract available Active, not recruiting --> Recruiting
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Review, Journal: Pharmacotherapy for Sexual Dysfunction in Women. (Pubmed Central) - May 6, 2022
The DSM-5 revision combining HSDD and FSAD into one diagnostic category is a less accurate characterization of these separate disorders and may hinder access to demonstrated effective treatments for the women with these conditions. There are a wide range of pharmacological, other physiological, and psychological treatment options available for women with FSD, which can be offered based on their specific symptoms, potential benefits/risks, and preferences.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Clinical, P1 data, Journal: Effect of bremelanotide on body weight of obese women: data from two phase 1 randomized controlled trials. (Pubmed Central) - Apr 22, 2022
There are a wide range of pharmacological, other physiological, and psychological treatment options available for women with FSD, which can be offered based on their specific symptoms, potential benefits/risks, and preferences. Agonist activity at the MC4R may aid in reducing caloric intake and weight loss in obese women.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Review, Journal: Medical Treatment of Female Sexual Dysfunction. (Pubmed Central) - Apr 19, 2022
Flibanserin and bremelanotide are psychoactive agents indicated for the treatment of generalized acquired hypoactive sexual desire disorder (HSDD) in premenopausal women, whereas transdermal testosterone is effective on HSDD in postmenopausal women. Menopause hormone therapy (systemic and local) is the mainstay for individualized management of women at midlife.
- |||||||||| Ophena (ospemifene) / Shionogi, Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Journal: Pharmacotherapy for female sexual dysfunctions (FSDs): What is on the market and where is this field heading? (Pubmed Central) - Apr 19, 2022
The authors also report briefly intravaginal DHEA (prasterone), local estrogen therapy (LET) and ospemifene to manage effectively vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM)...Approved pharmacotherapies for FSD are limited. Validated multidimensional instruments and adequate objective measures of physical and mental responses to sexual external and internal incentives are mandatory to identify women suitable to chronic or on-demand treatments and to assess their pattern of response in research and practice.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Journal: Safety Profile of Bremelanotide Across the Clinical Development Program. (Pubmed Central) - Mar 16, 2022
P3
Although not deemed clinically important, bremelanotide should be used with caution in patients at risk of cardiovascular disease, and blood pressure should be well controlled during treatment. Clinical Trial Registration number: NCT02333071 [Study 301] and NCT02338960 [Study 302].
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
P3 data, Journal: Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. (Pubmed Central) - Mar 16, 2022
Statistically significant improvements were observed in the presence or absence of decreased arousal, and regardless of HSDD duration. Bremelanotide was associated with statistically significant improvements in sexual desire and reduced distress across several prespecified subgroups, with few exceptions.
- |||||||||| Scenesse (afamelanotide) / Clinuvel, Vyleesi (bremelanotide) / Palatin Technologies
Journal: Structural insights into ligand recognition and activation of the melanocortin-4 receptor. (Pubmed Central) - Jan 27, 2022
Together with pharmacological studies, our results reveal the conserved binding mode of peptidic agonists, the distinctive molecular details of small-molecule agonist recognition underlying receptor subtype selectivity, and a distinct activation mechanism for MC4R, thereby offering new insights into G protein coupling. Our work may facilitate the discovery of selective therapeutic agents targeting MC4R.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Review, Journal: Bremelanotide for Treatment of Female Hypoactive Sexual Desire. (Pubmed Central) - Jan 26, 2022
Studies showed improvements in desire, arousal, and orgasm scores when 1.75 mg of bremelanotide was administered before sexual activity compared to a placebo. Bremelanotide is a promising way to treat HSDD.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Clinical, Review, Journal: Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment. (Pubmed Central) - Dec 25, 2021
The 2 recently approved medications for HSDD, flibanserin and bremelanotide, are reviewed as well as off-label treatments. Overall, HSDD represents a common yet likely underrecognized disorder that midwives and other health care providers who care for women across the life span are in a unique position to address.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Clinical, Review, Journal: Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent. (Pubmed Central) - Dec 16, 2021
Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin. Reconsideration of regulatory decisions to approve these drugs is in order, as well as a broader examination of how future regulatory decisions can better address conflicts of interest and clinically meaningful benefit.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Clinical, P3 data, Journal: Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. (Pubmed Central) - Nov 29, 2021
Bremelanotide's modest benefits on incompletely reported post-hoc measures of questionable validity in combination with participants substantially preferring to take placebo suggest that the drug is generally not useful. Kingsberg et al.'s data reporting and measurement practices were incomplete and lacked transparency.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Sprout Pharma
Clinical, Review, Journal: Management of hypoactive sexual desire disorder in transgender women: a guide for clinicians. (Pubmed Central) - Nov 21, 2021
Among treatment options, transgender women may benefit of different sex therapy strategies and/or central nervous system-active medications-such as flibanserin, bremelanotide, bupropion and buspirone-and transdermal testosterone, bearing in mind that this option could be poorly accepted by patients due to the risk of virilizing effects. The lack of data regarding the efficacy of HSDD treatment options in transgender women emphasize the need for literature to focus more on this topic in the future.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Journal: LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of PIEDs. (Pubmed Central) - Nov 7, 2021
The characterization was carried out by the accurate mass measurements of MH ionic species, the study of their isotopic patterns and the associated relative isotopic abundance (RIA) values, as well as the accurate mass measurements of collision-induced product ions obtained in fragmentation experiments. LC-HRMS confirmed itself as a powerful analytical tool to elucidate the elemental composition and structural characteristics of unknown compounds.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Journal: Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm. (Pubmed Central) - Sep 25, 2021
P2
Evidence supports the validity and reliability of the FSDS-DAO for assessing sexually related distress in women with female sexual arousal disorder and/or hypoactive sexual desire disorder; the addition of the arousal and orgasm items did not impact the validity and reliability of the measure. Clinical Trial Registration ClinicalTrials.gov NCT01382719.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
New P3 trial: KD-BMT-301: A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) (clinicaltrials.gov) - Jun 29, 2021
P3, N=186, Active, not recruiting,
- |||||||||| Wellbutrin XL (bupropion hydrochloride ER) / Bausch Health, GSK
[VIRTUAL] Lifelong Anorgasmia in the Context of Long-Term Fluoxetine Use: A Case Report () - May 2, 2021 - Abstract #APA2021APA_325;
Future options include off-label sildenafil and bremelanotide (event-related treatment)...While there are currently no approved pharmacologic agents to address FOD specifically, we review excitatory, inhibitory, central and peripheral neurotransmitters and hormones involved in sexual climax, and discuss theoretical targets for pharmacologic intervention. We also review available pharmacologic treatments for other forms of female sexual dysfunction, including hypoactive sexual desire disorder.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies, Addyi (flibanserin) / Bausch Health
Clinical, Journal: Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment. (Pubmed Central) - Apr 13, 2021
Bremelanotide, a novel melanocortin receptor agonist, was recently approved by the FDA for the treatment of acquired, generalized HSDD in premenopausal women. Increased awareness and recognition of HSDD as a medical condition should provide an incentive for further clinical development of effective treatments for HSDD.
- |||||||||| Vyleesi (bremelanotide) / Palatin Technologies
Trial completion date, Trial primary completion date: Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder (clinicaltrials.gov) - Jan 13, 2021
P4, N=40, Recruiting,
The ultra-sensitive assay was applied to the quantification of bremelanotide plasma concentrations after oral administration to beagle dogs, which indicated minimal oral absorption. Trial completion date: Apr 2021 --> Aug 2022 | Trial primary completion date: Oct 2020 --> Aug 2022
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