[Translation] A single-center, randomized, open-label, two-dose, four-period, two-sequence, single-dose, completely repeated crossover bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸伐地那非片（规格：20mg，持证商：杭州民生药物研究院有限公司）与参比制剂盐酸伐地那非片（规格：20mg，持证商：Bayer AG，商品名：Levitra®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂盐酸伐地那非片和参比制剂盐酸伐地那非片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.) and the reference preparation vardenafil hydrochloride tablets (specification: 20 mg, licensee: Bayer AG, trade name: Levitra®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation vardenafil hydrochloride tablets and the reference preparation vardenafil hydrochloride tablets in healthy subjects.

Start Date09 Oct 2024

Sponsor / Collaborator

Hangzhou Minsheng Pharmaceutical Research Institute Co., Ltd.

CTR20243140

/ CompletedNot Applicable

盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study of vardenafil hydrochloride tablets in healthy subjects under fasting and fed conditions

主要目的比较空腹和餐后给药条件下，山东百诺医药股份有限公司提供的盐酸伐地那非片（20mg）与Bayer AG持证的盐酸伐地那非片（20mg，商品名：Levitra®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹和餐后给药条件下，山东百诺医药股份有限公司提供的盐酸伐地那非片（20mg）与Bayer AG持证的盐酸伐地那非片（20mg，商品名：Levitra®）在健康成年人群中的安全性。

[Translation]

Main purpose To compare the differences in the extent and rate of absorption of Vardenafil Hydrochloride Tablets (20 mg) provided by Shandong Bainuo Pharmaceutical Co., Ltd. and Vardenafil Hydrochloride Tablets (20 mg, trade name: Levitra®) licensed by Bayer AG in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary purpose To evaluate the safety of Vardenafil Hydrochloride Tablets (20 mg) provided by Shandong Bainuo Pharmaceutical Co., Ltd. and Vardenafil Hydrochloride Tablets (20 mg, trade name: Levitra®) licensed by Bayer AG in healthy adults under fasting and postprandial administration conditions.

Start Date09 Sep 2024

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

CTR20242575

/ CompletedNot Applicable

盐酸伐地那非口崩片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of vardenafil hydrochloride orodisintegrating tablets in healthy subjects under fasting/fed conditions

主要研究目的：健康受试者空腹/餐后状态下，口服单剂量盐酸伐地那非口崩片（受试制剂，哈尔滨三联药业股份有限公司生产）与盐酸伐地那非口崩片（参比制剂，Alembic Pharmaceuticals Inc.生产）后，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要研究目的：观察盐酸伐地那非口崩片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions after a single oral dose of vardenafil hydrochloride orodisintegrating tablets (test preparation, produced by Harbin Sanlian Pharmaceutical Co., Ltd.) and vardenafil hydrochloride orodisintegrating tablets (reference preparation, produced by Alembic Pharmaceuticals Inc.) was taken by healthy subjects in the fasting/postprandial state, and to evaluate whether the test preparation and the reference preparation are bioequivalent. The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation of vardenafil hydrochloride orodisintegrating tablets in healthy subjects.

Start Date05 Sep 2024

Sponsor / Collaborator

Harbin Medisan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Vardenafil Hydrochloride

100 Translational Medicine associated with Vardenafil Hydrochloride

100 Patents (Medical) associated with Vardenafil Hydrochloride

1,164

Literatures (Medical) associated with Vardenafil Hydrochloride

01 Jan 2025·Journal of Pharmaceutical and Biomedical Analysis

Identification of a novel vardenafil analogue, 19-O-propyl hydroxy vardenafil, as a dietary supplement adulterant

Article

Author: Tsai, Li-Yao ; Lin, Mei-Chih ; Wu, You-Lun ; Tseng, Su-Hsiang ; Kao, Ya-Min ; Lin, Yu-Ting ; Lee, Hui-Chun

A novel vardenafil analogue was discovered during adulterant screening of a dietary supplement. After extraction and purification, this analogue was identified using liquid chromatography-high resolution mass spectrometry (LC-HRMS) and nuclear magnetic resonance (NMR) analyses. The molecular formula determined using LC-HRMS was C₂₄H₃₄N₆O₅S. Fragmentation data suggested that this unknown compound may have two modifications to vardenafil. NMR analysis confirmed the presence of a hydroxyl group on the piperazine moiety and a propyl group attached to the phenoxy group. Consequently, this compound was named 19-O-propyl hydroxy vardenafil.

01 Nov 2024·International Journal of Impotence Research

The spreading information of YouTube videos on Phosphodiesterase 5 inhibitors: a worrisome picture from one of the most consulted internet source

Article

Author: Pezone, Gabriele ; Di Bello, Francesco ; Creta, Massimiliano ; Collà Ruvolo, Claudia ; Morra, Simone ; Passaro, Francesco ; Palmieri, Alessandro ; Di Mauro, Ernesto ; Califano, Gianluigi ; Cilio, Simone ; Fraia, Agostino ; Imbimbo, Ciro ; Longo, Nicola ; Celentano, Giuseppe ; La Rocca, Roberto ; Capece, Marco

Several previous studies on YouTube^TM information on medical topics have already been published. The current study aimed to evaluate the quality information of YouTube^TM videos on Phosphodiesterase 5 inhibitors (PDE5-is). A systematic search on YouTube™ was conducted using 30 keyword combinations. For each keyword's combination, the first 50 videos were recorded. The quality of videos on YouTube™ was assessed with Patient Education Materials Assessment Tool for audio-visual content (PEMAT A/V), DISCERN score and a specified created Misinformation tool. According to the selection criteria, 229 YouTube™ videos were suitable for the analyses. Videos were stratified according to the five main identified topics: sildenafil [n = 98; 42.79%] vs tadalafil [n = 50; 21.83%] vs vardenafil [n = 44;19.21%] vs avanafil [n = 17; 7.42%] vs PDE5-is in general [n = 20; 8.73%]. The median overall PEMAT A/V Understandability score and Actionability score were 55% (interquartile range [IQR]: 42-75) and 0% (IQR = 0-67), respectively. Specifically, according to our stratification, YouTube Videos on avanafil reached higher values of both Understandability and Actionability (72.7% and 66.7, respectively) in contrast to other categories. According to DISCERN tool, the total overall median score was 29.5 (IQR = 18-41). According to Misinformation scale, the item 1 ('sexual stimulation') harboured an overall median score of 2 (IQR = 1-2); the item 2 ('side effects') an overall median score of 2 (IQR = 1-3); the item 3 ('treatment choices') an overall median score of 1 (IQR = 1-2); the item 4 ('contraindications') an overall median score of 2 (IQR = 1-2). YouTube™ is a fast and open-access source for mass information. The overall quality of the PDE5-is contents provided is sadly unsatisfactory. Nowadays, YouTube™ cannot be recommended as a reliable source of information on PDE5-is.

01 Nov 2024·Neurological Sciences

Phosphodiesterase-5 inhibitors use and the risk of alzheimer's disease: a systematic review and meta-analysis

Review

Author: Saad, Yousef Hesham ; Abouelmagd, Moaz Elsayed ; Alnajjar, Asmaa Zakria ; Elrosasy, Amr ; Hassan, Atef ; Abdelmeseh, Maickel ; Abbas, Abdallah ; Eid, Mahmoud

AbstractBackgroundThe management of Alzheimer's disease (AD) poses considerable challenges, necessitating the pursuit of innovative therapeutic approaches. Recent research has spotlighted the promising role of phosphodiesterase type 5 inhibitors (PDE5Is) in reducing the prevalence of AD, utilizing their vasodilatory properties to suggest a potential neuroprotective effect. This meta-analysis and systematic review aims to assess the relationship between the use of PDE5Is and the risk of AD.MethodsA detailed examination was carried out across several electronic databases till March 2024, including PubMed, Web of Science, Scopus, CENTRAL, and Embase. The focus was on identifying studies that compare the occurrence of AD among PDE5I users vs non-users. Through a random-effects model, pooled hazard ratios (HRs) were calculated, in alignment with guidelines from the Cochrane Handbook for Systematic Reviews and Meta-Analysis and the PRISMA standards.ResultsThis analysis included six studies, cumulating a participant count of 8,337,313, involving individuals treated with sildenafil, tadalafil, and vardenafil, against a control group undergoing other or no treatments. The cumulative HR for AD risk among PDE5I users versus the control group was 0.53 (95% CI: 0.32–0.86, p = 0.008), signaling a markedly reduced likelihood of AD development in the PDE5I group. Particularly, sildenafil usage showed a significant risk reduction (HR: 0.46, 95% CI: 0.31–0.70, p < 0.001), while findings for tadalafil and vardenafil were not significant. Test of subgroup differences found no difference between male and female participants in the risk of AD.ConclusionsOur findings suggest that the use of PDE5Is is associated with a reduced risk of AD, highlighting its potential as a protective agent against neurodegenerative diseases. Given the very low quality of evidence and the heterogeneity among the included studies, further high-quality research is warranted to confirm these findings and elucidate the underlying mechanisms. Register number PROSPERO 2024: CRD42024522197.

News (Medical) associated with Vardenafil Hydrochloride

08 Jan 2025

·www.echemi.com

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

Drug ApprovalNDA

21 Jun 2024

·www.drugs.com

Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction

CRANBURY, N.J., June 20, 2024. Palatin Technologies, Inc., 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. 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. SOURCE Palatin Technologies, Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 2OligonucleotidePhase 3Drug Approval

20 Jun 2024

·www.prnewswire.com

Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED)

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.

Phase 2Phase 3Oligonucleotide

100 Deals associated with Vardenafil Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Vardenafil Hydrochloride	G04BE09	DB00862

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Erectile Dysfunction	LI	Bayer AG	04 Mar 2003
Erectile Dysfunction	IS	Bayer AG	04 Mar 2003
Erectile Dysfunction	NO	Bayer AG	04 Mar 2003
Erectile Dysfunction	EU	Bayer AG	04 Mar 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 1	US	Bayer HealthCare Pharmaceuticals, Inc.	19 Aug 2003
Hypertension	Discovery	-	Bayer AG	01 Feb 2003
Depressive Disorder	Discovery	FR	Bayer AG	01 Dec 2002
Depressive Disorder	Discovery	US	Bayer AG	01 Dec 2002
Depressive Disorder	Discovery	ES	Bayer AG	01 Dec 2002
Depressive Disorder	Discovery	CA	Bayer AG	01 Dec 2002
Depressive Disorder	Discovery	IT	Bayer AG	01 Dec 2002
Spinal Cord Injuries	Discovery	-	Bayer AG	01 Oct 2002
Traumatic spinal cord injury	Discovery	-	Bayer AG	01 Oct 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2020	Not Applicable	-	-	vardenafil	lmixruhqur(kwuwoqaoml) = npubyuptpe qahahpohtw (fzfgfuveav ) View more	Positive	07 Sep 2020
ESC2018	Not Applicable	-	-	Vardenafil	dnbjwmaxub(uhcyenvdwj) = wlxzpjpilv smrbcfmxvh (vcbnvcqorn )	-	22 Apr 2018
				ZDF with vehicle (ZDFLV)	dnbjwmaxub(uhcyenvdwj) = szbqqdtxzb smrbcfmxvh (vcbnvcqorn )
ASN2012	Not Applicable	Hypertension	-	Vehicle	tocmdhymlk(otwoohcetd) = zpzaqjkbor drgmutdhkj (pscettvftm ) View more	-	30 Oct 2012
				Ang II	tocmdhymlk(otwoohcetd) = zsxyzawpco drgmutdhkj (pscettvftm ) View more
NCT00631969 \| NCT00655629 (Pubmed \| J Sex Med)	Phase 3	Erectile Dysfunction	-	Vardenafil ODT	upotneidcr(jzwrjtymkt) = eoguamdebe boqbwybngg (qxoqmnxgxr )	-	01 Oct 2011
				Placebo	upotneidcr(jzwrjtymkt) = rafoqztrba boqbwybngg (qxoqmnxgxr )
NCT00738400 (ED-METABOLIC, CTgov)	Phase 4	Metabolic Syndrome \| Erectile Dysfunction	150	Vardenafil (Levitra, BAY38-9456) (Vardenafil (Levitra, BAY38-9456))	yqeqaurrwy(gboecljeqs) = bbeespzpqq ujilttplml (mugalsziqj, doohalzszp - echtfmvvkz) View more	-	01 Jun 2011
				Placebo (Placebo)	yqeqaurrwy(gboecljeqs) = nzipiwxiji ujilttplml (mugalsziqj, lyesbqxvns - bygaplawwv) View more
NCT00631969 (CTgov)	Phase 3	Erectile Dysfunction	362	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	yvanoovlls(cvsjqwhzkz) = ioabntmslx joykngztmj (bckqlgllqf, qdkgkdgrjn - lcaccbpffg) View more	-	21 Jan 2011
				Placebo (Placebo)	yvanoovlls(cvsjqwhzkz) = evpenlfamw joykngztmj (bckqlgllqf, pabupolftt - iubsvauhqh) View more
NCT00655629 (CTgov)	Phase 3	Erectile Dysfunction	339	Vardenafil ODT (STAXYN, BAY38-9456) (Vardenafil ODT (STAXYN, BAY38-9456))	lblgyntynf(rtrajkguti) = ewxyuqfria zqamiuuzga (hiyeqwaeme, jnhltnwcat - oymcxdkykp) View more	-	21 Jan 2011
				Placebo (Placebo)	lblgyntynf(rtrajkguti) = esldjqnpdk zqamiuuzga (hiyeqwaeme, vtebhivaft - sukorpgvhi) View more
AUA2010	Not Applicable	Prostatic Diseases PSA serum levels	-	Vardenafil 20 mg	keyinjkmaj(orijehvztb) = tamobjrftn ivuelfnfsz (wyjhwgkxnh )	Positive	01 Apr 2010
NCT00478881 (CTgov)	Phase 2	Urinary Bladder, Overactive	397	Vardenafil HCl (Levitra, BAY38-9456) (Vardenafil HCl (Levitra, BAY38-9456))	uljnlayphd(sytydtxbcy) = bsjgjgfikx huepuhaxrn (rxzrvmfmnw, iqaxwdcvvg - wntbbxoirs) View more	-	24 Dec 2009
				Placebo (Placebo)	uljnlayphd(sytydtxbcy) = sqhtbzkkdm huepuhaxrn (rxzrvmfmnw, lnnbjbsxzr - ebiovpcmio) View more
NCT00853840 (CTgov)	Phase 4	Acquired Immunodeficiency Syndrome	18	Vardenafil+Maraviroc (Maraviroc + Vardenafil (Treatment A))	puvtxowsld(awmkqoqnsv) = wlzrihqriv pndyuqljht (rboijnlpqp, mbvmqaribp - jaojzzjbaw) View more	-	23 Jun 2009
				Placebo+Maraviroc (Maraviroc + Placebo (Treatment B))	puvtxowsld(awmkqoqnsv) = lryjddsfed pndyuqljht (rboijnlpqp, uyeuszxsdb - qsvylruhhl) View more

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