Alprostadil

In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025 CRANBURY, N.J., June 20, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy. Topline data from the Phase 2 clinical study is expected by the end of calendar year 2024. "Approximately 30-40% of ED patients exhibit little or no response to PDE5i monotherapy, such as Viagra, Cialis, and Levitra," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "These PDE5i monotherapy drugs account for over $4 billion of annual sales, yet PDE5i monotherapy does not work for a significant portion of ED patients. This represents a substantial unmet medical need for more effective ED treatments. Based on our clinical data and mechanisms of action research, we believe that BMT combined with a PDE5i is synergistic and will be a clinically meaningful ED treatment for non-responders to current PDE5i monotherapy." The Phase 2 clinical trial is designed to enroll approximately 50 patients to be treated with BMT co-administered with a PDE5i in an open-label, dose escalation study treating men with ED who are considered non-responders to PDE5i monotherapy treatment. The clinical study is being conducted under an investigator-sponsored Investigational New Drug (IND) and has Food and Drug Administration (FDA) clearance and Institutional Review Board (IRB) approval. The study's primary objective is to assess the safety and efficacy of BMT co-administered with a PDE5i for the treatment of ED in males who have not adequately responded to prior PDE5i monotherapy. "ED has become more prominent over the last several decades, especially in younger adults, and represents a mounting health concern causing a significant effect on men's quality of life," said Jed Kaminetsky, MD, FACS, Urologist, Director of Research, Integrated Medical Professionals, a Division of Solaris Health and the clinical study lead investigator. "Many patients in my practice are seeking better results from their ED treatment. Men with more severe ED do not respond as well using a PDE5i and have limited non-surgical options. I have used bremelanotide in my practice for men with ED. I believe the combination of bremelanotide with a PDE5i could potentially be an effective treatment option for the PDE5i non-responders suffering from ED." Palatin has conducted multiple clinical studies of monotherapy BMT and combination therapy BMT plus a PDE5i in men with ED and observed statistically significant and clinically meaningful effects on improving erectile function. In addition, sub-cutaneous bremelanotide 1.75 mg (Vyleesi®) is approved by the FDA for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women and has demonstrated an increase in sexual desire and decrease in distress associated with low desire. Palatin has developed a new co-formulation of bremelanotide and a PDE5i which can be administered as a single injection. An IND for this novel co-formulation for the treatment of ED is expected to be filed with the FDA later this calendar year and a potential Phase 3 clinical study in ED patients who do not respond to PDE5i monotherapy is expected to start in the first half of calendar year 2025. About Erectile Dysfunction (ED) Erectile dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse and affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention. Approximately 30-40% of men are non-responsive to standard therapies with phosphodiesterase-5 inhibitors (PDE5i) such as sildenafil (Viagra®), vardenafil (Levitra®) and tadalafil (Cialis®). There are limited therapeutic options for ED patients non-responsive to PDE5i therapy, including alprostadil for direct penis injection or urethral suppositories, surgical penile implants and various devices. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on and follow us on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策近日，国家卫健委公布了2024年版的二级公立医院和三级公立医院绩效考核目标，共28个考核指标，这其中和药品使用直接相关的包括：抗菌药使用强度、基本药物使用、集采药品使用、重点监控药品收入占比、重点监控耗材收入占比等。除了集采药品、基本药物使用要求逐步提高外，其他都要逐步降低。笔者一直认为药品使用各种相关考核指标中，只有金额占比是最为实实在在的考核指标，能够给药企带来最切实的变化。今年，基本药物的考核全面升级，在医院基药使用考核中，金额占比开始纳入考核，基本药物迎来全面利好。重点监控上，本次仍考核第一批纳入重点监控目录的品种，新增入目录23个品种逃过一劫。国家集采中选药品使用上，二级医院考核采购金额，让国采中选药品在二级医院迎来更多利好，国采中选药品可以趁势在二级医院做推广。重点监控药品：只监控第一批目录品种重点监控药品和重点监控耗材使用占比是二级和三级公立医院绩效考核指标，对于新增进第二批重点监控目录的品种来说，今年逃过了一劫。国家卫健委二级医院和三级医院考核细则中，都明确今年关于重点监控用药考核仍是考核第一批重点监控药品。（下面两图分别为三级医院和二级医院考核指标的考核说明）2023年1月13日，国家卫健委公布第二批重点监控药品名单，共30个品种被纳入。据目录公布时政策要求，未纳入第二批《目录》即调出目录品种，应当持续监控至少满1年后可不再监控，以促进临床合理用药水平持续提高。而仍持续保留在重点监控目录内的，要按照要求加强重点监控。对于所有品种，各地要以规范临床用药行为、促进合理用药为工作目标，对纳入本目录的药品制定完善临床应用指南，明确临床应用的条件和原则，加强合理用药监管。有13个品种被调整出重点监控目录，这些品种为脑苷肌肽、小牛血清去蛋白、复合辅酶、丹参川穹嗪、转化糖电解质、鼠神经生长因子、胸腺五肽、核糖核酸II、曲克芦丁脑蛋白水解物、核糖核酸、长春西汀、马来酸桂哌齐特、小牛血去蛋白提取物。7个品种仍保留在目录内：依达拉奉、神经节苷脂、骨肽、脑蛋白水解物、奥拉西坦、前列地尔、磷酸肌酸钠。23个品种为新增加品种，这些品种为：奥美拉唑、人血白蛋白、头孢哌酮舒巴坦、银杏叶提取物、泮托拉唑、复方氨基酸、地佐辛、倍他司汀、布地奈德、烟酰胺、头孢他啶、哌拉西林他唑巴坦、艾司奥美拉唑、吡拉西坦、左氧氟沙星、法莫替丁、雷贝拉唑、罂粟碱、烟酸、乙酰谷酰胺、兰索拉唑、美罗培南、头孢噻肟。公立医院绩效考核一般是去年一些指标进行考核和回顾，国家卫健委要求已经被调出仍保留一年监控期，继续考核被调出的13个品种属于政策范围内，但去年新增加的23个品种未被纳入考核指标仍是让人感到意外。三级医院：基药迎来更多利好金额占比开始纳入基药考核中，基本药物正迎来全面利好。其一，我们看到在考核指标中，无论是二级医院还是三级医院，都考核到基药的金额占比。其中二级医院考核的核心指标是基本药物采购金额占比，即年度内医院基本药物采购金额数占医院同期采购药物金额总数的比例。而三级医院延伸考核指标里面，考核的是基本药物配备使用金额占比，考核进一步升级了，这个比例对于三级公立医院约束力将更强，因为不仅仅是采购，还考核到使用金额，这个考核指标对于提升基本药物在三级医院的使用刺激作用将更为明显。其次，是从考核指标上，无论是二级医院还是三级医院，都有不少考核指标与基本药物使用相关。其中，二级医院除了采购指标外，和基药相关的延伸考核指标还包括：基本药物采购品种数占比、门诊处方使用占比、住院使用占比等，预计是为了防止出现基本药物使用集中于一些高价基药上。三级医院考核上更为细化，除了上面提及基本药物采购品种占比及其延伸考核指标外，核心指标还包括基药门诊使用占比、住院患者使用率等2个指标。每个指标后面都有一个延伸指标，由此三级医院基药方面考核达到了6个。二级医院：集采中选药品使用更有利好金额考核指标同样出现在了二级医院关于国家集采中选药品考核中。在这一指标中，二级医院考核的采购金额占比，虽然不是最为理想的使用金额占比，但没有采购哪来的使用？在这一考核指标指引下，国采中选药品在二级医院将迎来更多利好，国采中选厂家也可以借助这一政策优势更好推广国采中选药品。附：第一批重点监控品种名单(来源:趣学术）药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看