Lansoprazole

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

Retrieved on: 
Tuesday, November 28, 2023
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“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.

Brainomix Partners with TIPAL Trial to Assess Its Novel IPF Biomarker in Lung Disease

Retrieved on: 
Friday, September 8, 2023
Social work, CT, Idiopathic disease, Idiopathic pulmonary fibrosis, Oxford, National Institute of Health Research and Development (Indonesia), NNUH, Scar, ILD, Public, FVC, Lansoprazole, Norfolk and Norwich University Hospital, Lung, Government, Fibrosis, Department of Health and Social Care, Vital capacity, High-resolution scheme, Patient, Spirometry, NHS foundation trust, Heartburn, WRV, NIHR, Diagnosis, AI, IPF, Royal Brompton Hospital, Medical imaging

OXFORD, England, Sept. 8, 2023 /PRNewswire/ -- Brainomix announced today that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its groundbreaking e-Lung platform. The TIPAL trial, funded by the National Institute of Health Research (NIHR) and sponsored by the Norfolk and Norwich University Hospitals (NNUH) NHS Foundation Trust, is a placebo-controlled 52-week multi-centre study that is evaluating the impact of lansoprazole – a commonly prescribed medication for indigestion, heartburn and acid reflux – on patients with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). IPF is a condition marked by relentless decline in lung function, but with a variable disease trajectory.

Key Points: 
  • OXFORD, England, Sept. 8, 2023 /PRNewswire/ -- Brainomix announced today that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its groundbreaking e-Lung platform.
  • IPF is a condition marked by relentless decline in lung function, but with a variable disease trajectory.
  • The 298 patients expected to be enrolled in the trial will perform home spirometry tests to measure their forced vital capacity (FVC).
  • Professor Andrew Wilson, TIPAL Chief Investigator, said "It is great to have the chance to incorporate the cutting-edge CT scanning technology developed by Brainomix into the TIPAL study.

Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA

Retrieved on: 
Tuesday, May 23, 2023
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This resubmission responds to the Complete Response Letter (CRL) issued by the FDA in February 2023 relating to specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP).

Key Points: 
  • This resubmission responds to the Complete Response Letter (CRL) issued by the FDA in February 2023 relating to specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP).
  • As previously communicated, Phathom implemented mitigation measures, including a minor drug product tablet reformulation, to inhibit the growth of NVP, and has been conducting a stability program to demonstrate these measures are effective and support the commercial shelf life.
  • As agreed with the Agency, we plan to provide the final six-month stability data during their review as it becomes available.
  • If the NDA is approved, a combined U.S. commercial launch for the Erosive GERD and H. pylori indications is planned for the fourth quarter of 2023.

COUNTRY STAR MITCHELL TENPENNY AND PREVACID ANNOUNCE "BEAT THE BURN" - A LIVE TIK TOK CONCERT TO SING AWAY STRESS

Retrieved on: 
Tuesday, May 16, 2023
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NASHVILLE, Tenn., May 16, 2023 /PRNewswire/ -- Did you know that stress is a leading cause of frequent heartburn? Stressburn is what we like to call it and it can be prevented with Prevacid 24HR.

Key Points: 
  • Country Star Mitchell Tenpenny announces live Tik Tok concert ahead of upcoming tour.
  • Country star Mitchell Tenpenny is teaming up with Prevacid - a leader in frequent heartburn prevention - to host "Beat the Burn," a live Tik Tok concert dedicated to singing stressburn away.
  • Inspired by his own experience with stressburn, Tenpenny will take to his Tik Tok channel to sing about real life stressors - in real time.
  • "I'm super excited to be partnering with Prevacid to bring you our Beat The Burn concert," says Tenpenny.

Phathom Pharmaceuticals Presents New Data at Digestive Disease Week® (DDW) 2023

Retrieved on: 
Tuesday, May 9, 2023
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Acid suppression has been shown to be an important factor in the treatment of acid-related gastrointestinal disorders, especially Erosive GERD.

Key Points: 
  • Acid suppression has been shown to be an important factor in the treatment of acid-related gastrointestinal disorders, especially Erosive GERD.
  • By week 4, PCABs attained median healing rates nearly 200% higher than H2RAs and 25% higher than PPIs (~90% for PCABs, ~30% for H2RAs, 70% for PPIs).
  • By week 8, median healing rates for PCABs increased to nearly 100%, whereas H2RAs and PPIs reached ~50% and ~78%, respectively.
  • Following the conclusion of DDW 2023, the abstracts will be posted to Phathom’s publications and scientific section of the company website.

Phathom Pharmaceuticals Presents Data on Novel Potassium-Competitive Acid Blocker (PCAB) Vonoprazan from a Range of Studies at Digestive Disease Week® (DDW) 2022

Retrieved on: 
Tuesday, May 24, 2022
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VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) contain vonoprazan, an oral small moleculepotassium-competitive acid blocker (PCAB) co-packaged with antibiotics.

Key Points: 
  • VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) contain vonoprazan, an oral small moleculepotassium-competitive acid blocker (PCAB) co-packaged with antibiotics.
  • VOQUEZNA TRIPLE PAK is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin-class antibacterial, and clarithromycin, a macrolide antimicrobial.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.
  • Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB).

Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis

Retrieved on: 
Monday, March 14, 2022
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Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.

Key Points: 
  • Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S.
  • We believe there is great interest among patients and healthcare providers for new treatment options to address the shortcomings of current treatment.
  • If approved, vonoprazan has the potential to satisfy the large unmet needs of millions of patients and set a new treatment paradigm in EE.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.

Phathom Pharmaceuticals Announces New Data at ACG 2021 Annual Scientific Meeting

Retrieved on: 
Sunday, October 24, 2021
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Both vonoprazan-based regimens were generally well tolerated with a safety profile comparable to lansoprazole-based triple therapy in the trial.

Key Points: 
  • Both vonoprazan-based regimens were generally well tolerated with a safety profile comparable to lansoprazole-based triple therapy in the trial.
  • Phathom submitted new drug applications in September 2021 to the U.S. FDA for vonoprazan-based regimens for the treatment of H. pylori infection.
  • Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.
  • The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved.

Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial

Retrieved on: 
Monday, October 18, 2021
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The PHALCON-EE results are a major milestone for Phathom and for the 20 million Americans suffering from erosive esophagitis.

Key Points: 
  • The PHALCON-EE results are a major milestone for Phathom and for the 20 million Americans suffering from erosive esophagitis.
  • In the first phase, vonoprazan 20 mg was compared to lansoprazole 30 mg in the healing of EE after up to 8 weeks of treatment (Healing Phase).
  • Overall, the safety results for vonoprazan observed in PHALCON-EE were consistent with the results observed in prior clinical studies.
  • The positive PHALCON-EE data provides Phathom with access to an additional $50 million from its term loan facility with Hercules Capital.

Phathom Pharmaceuticals Announces Results from VONO-103, a Phase 1 Study Evaluating Gastric Acid Inhibition of Vonoprazan and Lansoprazole (PREVACID®)

Retrieved on: 
Monday, September 27, 2021
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FLORHAM PARK, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported results from VONO-103, a Phase 1 trial evaluating the effects of vonoprazan 20 mg once daily (“QD”) and lansoprazole 30 mg QD in healthy U.S. subjects. In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole. The study treatments were generally well tolerated with no serious adverse events reported.

Key Points: 
  • In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole.
  • The greater gastric acid inhibition was maintained after seven days of once daily dosing.
  • The mean 24-hour pH value on Day 7 for vonoprazan was 5.9 as compared to 3.8 for lansoprazole (p
  • VONO-103 is the first pharmacokinetic and pharmacodynamic (PK/PD) and safety study comparing vonoprazan 20 mg QD and lansoprazole 30 mg QD.