Lansoprazole

National TV and digital media campaign aims to motivate millions of people suffering from Erosive GERD to learn more about VOQUEZNA® (vonoprazan), the first and only FDA-approved potassium-competitive acid blocker (PCAB) A Media Snippet accompanying this announcement is available by clicking on this link. FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1 The multi-channel campaign delivers strong, compelling, and motivating efficacy and safety information to educate consumers about this new treatment option. It is currently live at VOQUEZNA.com and through Connected TV – streaming consumer content on popular platforms such as Prime Video, Hulu, and Peacock. The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads. Broadcast television promotion is anticipated to launch in the second quarter of 2024. By strategically utilizing a wide array of platforms, and leveraging advanced targeting, Phathom anticipates this campaign will reach the millions of Erosive GERD sufferers and motivate these patients to seek a new class of treatment that works differently than proton pump inhibitors (PPIs). “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day. Although Erosive GERD is a highly symptomatic condition that can have a detrimental impact on millions of patients, there has been little medical innovation in this category in decades, until now,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals. “We believe our new DTC campaign is accessible, memorable, and informative. Our goal is to connect with people unsatisfied with their current treatment options and empower them to explore the power of VOQUEZNA with their healthcare provider.” VOQUENZA, the first and only U.S. Food and Drug Administration (FDA)-approved treatment of its kind, helps to heal and maintain healing of acid-related damage to the lining of the esophagus, in addition to helping to provide 24-hour relief of associated heartburn in most adults. Its novel mechanism of action provides rapid, potent, and durable acid suppression in a way that is distinct from other prescription and over-the-counter medications.2 VOQUEZNA offers a novel therapeutic option with strong efficacy compared to standard of care PPI lansoprazole, demonstrated across a range of clinically important endpoints, including maintaining healing of Erosive GERD for all patients through six months. VOQUEZNA 20 mg demonstrated a strong healing rate of 93% compared to 85% for lansoprazole 30 mg. And of those healed, 79% stayed healed for 6-months on VOQUEZNA 10 mg compared to 72% taking lansoprazole 15mg.1 The most common side effects of VOQUEZNA for the treatment of Erosive GERD include stomach inflammation, diarrhea, stomach bloating, stomach pain, nausea, indigestion, high blood pressure, and urinary tract infection.1 Further information on these Phase 3 results from Phathom’s pivotal clinical study is available at www.voquezna.com. Phathom is offering savings programs for eligible patients who face coverage or affordability issues, including a savings card program that allows for eligible patients with commercial insurance to pay as little as $25 for their VOQUEZNA prescription. The company has also partnered with BlinkRx, an end-to-end digital fulfillment channel that helps eligible patients find the most affordable option for filling their VOQUEZNA prescription. For more information, visit www.voquezna.com/savings. To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here. If you are considering a new treatment option for Erosive GERD, you should speak to your healthcare provider to see if VOQUEZNA may be right for you. VOQUEZNA is marketed exclusively by Phathom Pharmaceuticals, Inc. Please visit www.voquezna.com to learn more about VOQUEZNA. INDICATION AND IMPORTANT SAFETY INFORMATION What is VOQUEZNA? VOQUEZNA® (vonoprazan) is a prescription medicine used in adults: for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis. It is not known if VOQUEZNA is safe and effective in children. Do not take VOQUEZNA if you: are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching and swelling of your face, lips, tongue, or throat.are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY, CABENUVA) used to treat HIV-1 (Human Immunodeficiency Virus). Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you: have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).have kidney or liver problems.are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. VOQUEZNA may affect how other medicines work, and other medicines may affect how VOQUEZNA works. Especially tell your healthcare provider if you take medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY, CABENUVA). What are the possible side effects of VOQUEZNA?VOQUEZNA may cause serious side effects including: A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools, stomach pain, and fever that does not go away.Bone fractures (hip, wrist, or spine): Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening: Skin rash which may have blistering, peeling, or bleeding on any part of your skin.You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be the first sign of a severe skin reaction. Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you have been on VOQUEZNA for a long time.Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of hands, feet, or voice.Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time. The most common side effects of VOQUEZNA for treatment of Erosive Esophagitis include: stomach inflammationdiarrheastomach bloatingstomach painnauseaindigestionhigh blood pressureurinary tract infection These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see Patient Information and full Prescribing Information for VOQUEZNA. About Erosive GERD (gastroesophageal reflux disease)Erosive GERD, also referred to as Erosive Esophagitis (EE), is a subtype of gastroesophageal reflux disease (GERD) characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.3 There are estimated to be over 65 million individuals with GERD in the U.S., of which approximately 30% have Erosive GERD.4,5,6 In addition to experiencing troubling heartburn symptoms, patients with inadequately treated Erosive GERD may progress to more severe diseases including Barrett’s esophagus and esophageal cancer.4 About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. Vonoprazan helps provide rapid, potent, and durable acid suppression.2 Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. About Phathom Pharmaceuticals, Inc. Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the treatment of Erosive GERD and relief of related heartburn in adults, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X. Forward Looking StatementThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the potential success of Phathom’s DTC campaign. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PACK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. REFERENCES VOQUEZNA Prescribing Information, Phathom Pharmaceuticals, 2023.Laine L, Sharma P, Mulford DJ, et al. Pharmacodynamics and pharmacokinetics of the potassium-competitive acid blocker vonoprazan and the proton pump inhibitor lansoprazole in US subjects. Am J Gastroenterol. 2022;117(7):1158-1161.Dickman R, Maradey-Romero C, Gingold-Belfer R, Fass R. Unmet Needs in the Treatment of Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2015 Jul 30;21(3):309-19. doi: 10.5056/jnm15105.Savarino E, de Bortoli N, De Cassan C, et al. The natural history of gastro-esophageal reflux disease: A comprehensive review. Dis Esophagus. 2017;30(2):1-9.Machicado J.D., Greer J.B., Yadav D. (2020) Epidemiology of Gastrointestinal Diseases. In: Pitchumoni C., Dharmarajan T. (eds) Geriatric Gastroenterology. Springer, Cham. https://doi.org/10.1007/978-3-319-90761-1_7-1.U.S. Census Bureau. U.S. and World Population Clock. Accessed May 2022. https://www.census.gov/popclock. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2024 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc. 3/24 US-VPZ-24-0136

☝ 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