Motion Sickness

The nausea-fighting brand is highlighting the cultural impact of barf bags and ushering them into a new era with a documentary, a limited-edition collection of upcycled bags and a custom wearable art piece made from vintage bags TARRYTOWN, N.Y., April 3, 2024 /PRNewswire/ -- 1949 was a big year for barf, welcoming the invention of the barf bag and Dramamine®. Seventy-five years later, Dramamine, a Prestige Consumer Healthcare brand, thrives as the number one brand for motion sickness relief, but as Dramamine has risen in popularity, the use of barf bags has sadly diminished. To commemorate the joint anniversary, Dramamine® is breathing new life – not barf – into the paper product with a mission to save its fellow partner in puke. Continue Reading ‘The Last Barf Bag’ Campaign The Last Barf Bag: A Tribute to a Cultural Icon "The Last Barf Bag" campaign announced today by Dramamine®, alongside agency partners FCB Chicago, 360PR+ and The Shipyard, explores the cultural impact of a humble yet crucial American invention made all but defunct due to Dramamine's effectiveness in preventing unexpected upchucks. Through a new documentary, a collection of upcycled, repurposed bags and a pop-up museum exhibition, Dramamine is paying tribute to a once iconic part of our culture and history, nodding to the manufacturers, collectors, and nausea sufferers as they fill barf bags with new purpose and save their industry from irrelevance. "We're not saying that Dramamine has caused the demise of the barf bag, but we are saying that Dramamine is effective in minimizing their use, and we feel bad about that," said Erica Nesbitt, Senior Brand Manager of Dramamine at Prestige Consumer Health. "The 75th anniversary of both inventions felt like the right time to commemorate barf bags' contributions to culture and even rewrite what the future holds for them after Dramamine's impact has made their intended purpose all but obsolete." 'The Last Barf Bag' Documentary The documentary short film, The Last Barf Bag: A Tribute to a Cultural Icon, explores the cultural impact of a humble but crucially useful American invention. In it, the barf bag collectors and manufacturers whose passion can be credited to saving it from extinction, meet their unlikely ally: the makers of the anti-nausea medication that threatens its existence. Directed by the filmmaking collective Sunny Sixteen (Niles Jeran, Joshua Martin, Taylor Pendleton, and Caleb Babcock), The Last Barf Bag film introduces us to doctors, pilots, historians, collectors, brand managers, suppliers, flight attendants, and even regular people discussing their barf-worthy experiences. 'This is Not A Barf Bag' Limited Edition Collection Dramamine and barf bags have been fighting the good fight against nausea together, but the barf bag can make way for a purpose that goes way beyond catching upchucks. Consumers can get in on the crusade to save culture's cherished paper puke sacks by purchasing upcycled barf bags that can be used as puppets, chef's hats, popcorn bags, coloring canvases, vases and more. Each bag in its repurposed form will be available for purchase for $5, and bundles including a barf bag and Dramamine product will be $10 while supplies last. View the full collection here. Dramamine commissioned artist and creative director known for her appearance on NBC's Making It, Jessie Bearden, to display her craft on a new type of novel canvas…vintage barf bags. Bearden created a custom-made puffer coat using the colorful, patterned barf bags from around the world as material for a unique, only-of-its-kind item and exhibition piece. The puffer can be previewed at TheLastBarfBag.com today through April 17 at 12pm EST, when it will open up for one lucky consumer to secure the ultra-limited edition drop for just $7.50, a nod to the 75th anniversary milestone. "The unique look of vintage barf bags and their various colors and designs actually make a great template for a totally one-of-a-kind textile, and that's what inspired me to create a jacket," said Bearden. "I use a lot of unorthodox materials in my work, but a barf bag is a first! It makes me so happy knowing the piece will give a new life to these barf bags and I hope it serves as a conversation starter for the one lucky person who gets to wear it and spread the news of Dramamine's The Last Barf Bag project." Barf Bag Collection Exhibition Today in New York City for one day only, consumers and passersby can see The Last Barf Bag Exhibition in-person and watch an exclusive screening of the documentary on the day of its world premiere. The extensive collections of four of America's preeminent barf bag collectors will be on full display, including collections consisting of hundreds of bags collected over 5+ decades from around the world and even space. The exhibit will be open to the general public on April 3 from 12pm – 7pm at 437 N. Broadway. Following the exhibition, its collections and contents will be available to be viewed online. Consumers can pay their tributes to the barf bag's cultural impact and secure their piece of barf bag history by visiting TheLastBarfBag.com. Follow @DramamineOfficial for more information. ABOUT DRAMAMINE® Dramamine® is the #1 name in motion related nausea relief. Dramamine®'s range of solutions, in various forms, effectively prevent and treat nausea, dizziness, vomiting & queasiness. The brand falls under the Prestige Consumer Healthcare portfolio, which markets and distributes over-the-counter products in the U.S., Canada and Australia. With 75 years of experience, Dramamine® is the leader in nausea relief with a wide range of solutions created to help Americans unwanted bouts of barf. For more information on Dramamine® products, including Dramamine® Original Formula, Dramamine® Non-Drowsy, and the newest Dramamine® Ginger Chews, and for a list of retailers, visit . ABOUT PRESTIGE CONSUMER HEALTHCARE INC. Prestige Consumer Healthcare is a leading consumer healthcare products company with sales throughout the U.S. and Canada, Australia, and in certain other international markets. The Company's diverse portfolio of brands include Monistat® and Summer's Eve® women's health products, BC® and Goody's® pain relievers, Clear Eyes® and TheraTears® eye care products, DenTek® specialty oral care products, Dramamine® motion sickness treatments, Fleet® enemas and glycerin suppositories, Chloraseptic® and Luden's® sore throat treatments and drops, Compound W® wart treatments, Little Remedies® pediatric over-the-counter products, Boudreaux's Butt Paste® diaper rash ointments, Nix® lice treatment, Debrox® earwax remover, Gaviscon® antacid in Canada, and Hydralyte® rehydration products and the Fess® line of nasal and sinus care products in Australia. Visit the Company's website at . Contact: Megan Miller [email protected] SOURCE Dramamine

WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ: SXTP, SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame. The Company is continuing preparations for a June 1, 2024 start date as previously communicated. Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older. About ARAKODA® (tafenoquine) Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less frequent dosing for prophylaxis for malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. ARAKODA® (tafenoquine) Important Safety Information ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Contraindications ARAKODA® should not be administered to: Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status. Lactating women who are breastfeeding when the infant is found to be G6PD deficient or if G6PD status is unknown. Patients with a history of psychotic disorders or current psychotic symptoms. Patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA®. Warnings and Precautions Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins. Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible. Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy. Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia and hypersensitivity reactions may be delayed in onset and/or duration. Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams and anxiety. Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1- 888-834-0225 or FDA at 1-800-FDA-1088 or . ARAKODA® full prescribing information is here. About 60 Degrees Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals achieved FDA approval of its lead product, ARAKODA® (tafenoquine) for malaria prevention, in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the United States Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at . Cautionary Note Regarding Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Media Contacts: Sheila A. Burke SheilaBurke-consultant@60degreespharma.com (484) 667-6330 Investor Contact: Patrick Gaynes patrickgaynes@60degreespharma.com (310) 989-5666

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。美国食品药品监督管理局（FDA）作为全球医药监管的标杆，掌握着创新药开发公司的命脉，其对于药物上市的批准与否直接决定很多临床阶段创新药公司的命运，确保产品的安全性和有效性。新年伊始，又有哪些新药被FDA拒批了呢？让我们一起来看看。安斯泰来CLDN18.2单抗zolbetuximab：CLDN18.2阳性的局部晚期不可切除或转移性HER2阴性胃癌或胃食管交界处 （GEJ） 腺癌2024年1月9日，安斯泰来宣布其收到FDA就CLDN18.2单抗zolbetuximab上市申请发出的完整回复函（CRL），暂时拒绝批准上市，作为Claudin18.2阳性、HER2阴性的局部晚期不可切除或转移性胃或胃食管交界处（G/GEJ）腺癌的一线治疗方案。在CRL信函中，FDA指出了zolbetuximab第三方生产工厂未解决的缺陷，表示不能在原定的PDUFA日期前批准该药上市。其中，FDA未对zolbetuximab的临床数据提出任何疑问，也没有要求开展额外的临床试验。安斯泰来表示，这些生产缺陷不会造成任何安全性和有效性数据的隐患，公司正在与FDA和第三方制造商密切合作，以尽快解决该生产缺陷。安斯泰来重点领域管线布局Satsuma pharmaceuticals双氢麦角胺鼻粉产品 STS101：急性偏头痛2024年1月18日，FDA 拒绝批准日本SNBL旗下Satsuma Pharmaceuticals用于治疗急性偏头痛的双氢麦角胺鼻粉产品 STS101上市。STS101 是鼻腔给药偏头痛药物甲磺酸双氢麦角胺 (DHE) 的重新配制版本，利用 Satsuma 的专有设备进行递送，整体只有口红大小，方便携带和使用。完整回应函 (CRL) 中指出了STS101的化学、制造和控制 (CMC) 方面的问题。CRL 没有指出 STS101 有任何安全问题，也没有要求进行额外的研究。Satsuma 将与 FDA 讨论拒绝事宜，以重新提交上市申请。Satsuma 的上市申请是基于临床 III 期试验 ASCEND 研究和 SUMMIT 研究。在 ASCEND 研究中，18 个月内向 446 名入组患者提供了超过 10,500 剂 STS101。在治疗后两小时 STS101 可以使所有接受治疗的偏头痛发作中 34.2% 的患者摆脱疼痛，53.4% 患者摆脱最令人不适的症状，还消除了 94% 的治疗发作中对缓解药物的需求。但 SUMMIT 研究未达到主要疗效终点，STS101 在治疗后两小时无疼痛和最令人烦恼的症状方面与安慰剂没有显著区别。在安全性方面，STS101 没有发现严重不良事件，大多数毒性是轻微且短暂的。Defender pharmaceuticals鼻内东莨菪碱凝胶：晕动病引起的恶心和呕吐1月30日，Defender Pharmaceuticals宣布FDA签发了一份完整答复函（CRL），拒批了该公司用于预防晕动病引起的恶心和呕吐的鼻内东莨菪碱凝胶（DPI-386鼻用凝胶）NDA。该公司没有说明监管机构拒绝该药物的原因。DPI-386凝胶在一项3期、双盲、安慰剂对照研究(NCT05548270)中进行了评估，该研究包括约500名在海上航行中暴露于运动的成年人。研究参与者被随机分配到自行服用东莨菪碱鼻用凝胶(每0.12克凝胶含0.2毫克东莨菪碱HBr)或安慰剂组。研究结果显示，与安慰剂组相比，鼻内东莨菪碱组未报告呕吐和未请求抢救药物(主要终点)的患者比例显著更高。Defender公司总裁兼首席执行官、医学博士Barry I. Feinberg说：“Defender公司仍然相信鼻内东莨菪碱是一种安全有效的预防晕动病的疗法，我们将与FDA密切合作，确保我们能将这种创新的新产品推向市场。"Defender将继续寻求东莨菪碱的创新用途，并计划研究其在创伤性脑损伤、术后恶心和呕吐等一系列适应症方面的潜力。Minerva NeurosciencesRoluperidone：精神分裂症阴性症状2月27日，Minerva Neurosciences宣布收到FDA就Roluperidone用于治疗精神分裂症阴性症状的新药申请（NDA）发出的完整回复函（CRL），表示拒批其精神分裂症新药。受此消息影响，Minerva股价大跌59%。在CRL中，FDA 指出了以下四点拒批理由：虽然MIN-101C03研究在主要疗效终点上显示出统计学意义，但其本身不足以确立实质性的有效性证据；提交的NDA缺乏有关同时服用抗精神病药物的数据；NDA材料缺乏证明Roluperidone对改善精神分裂症阴性症状具有临床意义的必要数据；在已提交的安全性数据中，至少服用12个月拟议剂量（64mg）Roluperidone的患者数量不足。为了解决这些缺陷，FDA规定Minerva必须至少再提交一项积极、充分和对照良好的研究，以支持Roluperidone治疗阴性症状的安全性和有效性。Minerva还必须提供额外的数据来证明Roluperidone与其它抗精神病药物联合用药的安全性和有效性，以进一步支持Roluperidone的有效性并证明拟议剂量的长期安全性。TheratechnologiesTrogarzo：HIV2月27日，Theratechnologies（纳斯达克股票代码：THTX）宣布，美国食品和药物管理局（FDA）已就该公司关于Trogarzo®（ibalizumab-uiyk）维持剂量的肌肉注射（IM）给药方法的补充生物制品许可申请（sBLA）发出了拒绝备案函（RTF）。经初步审查，FDA认定该sBLA不够完整，无法进行实质性审查。RTF指出，sBLA没有包含建立Trogarzo® IM给药途径与静脉输注给药途径之间药代动力学桥梁所需的数据。Trogarzo®（ibalizumab-uiyk）是一种长效、CD4导向、附着后HIV-1抑制剂。在美国，Trogarzo®与其他抗逆转录病毒药物联用，适用于治疗目前抗逆转录病毒疗法无效的多重耐药HIV-1感染的重度治疗经验成人的1型人类免疫缺陷病毒（HIV-1）感染。Trogarzo® 在加拿大未获批准。总结据不完全统计，过去的2023年里有31款新药被FDA拒批，涉及到肿瘤、心脏疾病、呼吸系统疾病和皮肤病等等，被拒理由绝大多数集中于对产品有效性和安全性的质疑上，包括临床获益存疑、临床数据单一等问题。除临床问题外，CMC（化学、制造和控制）问题也开始成为FDA拒绝批准的另一项重要因素，这提示着监管机构对CMC要求愈加严格，企业不可忽视CMC问题。参考资料：各公司官网