Summary :
- The FDA approved two vonoprazan-based regimens, one with amoxicillin and clarithromycin (Voquezna Triple Pak) and one with amoxicillin (Voquezna Dual Pak), for the treatment of Helicobacter pylori (H. pylori) infection in adults, drugmaker Phathom Pharmaceuticals
- VOQUEZNA TRIPLE and DUAL PAKs each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB), and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in the overall patient population of the pivotal Phase 3 trial1
- VOQUEZNA treatment regimens are supplied in blister packs to help promote treatment compliance
- VOQUEZNA TRIPLE and DUAL PAKs offer physicians the flexibility of two different treatment options including a regimen without clarithromycin
- U.S. commercial launch anticipated in the third quarter of 2022
Both regimens contain antibiotics co-packaged with vonoprazan, a potassium-competitive acid blocker (PCAB), the first acid suppressant from a new drug class approved in the U.S. in over 30 years. PCABs work by inhibiting acid secretion in the stomach, which allows vonoprazan to achieve pH levels that result in improved antibiotic effectiveness.
About VOQUEZNA TRIPLE and DUAL PAKs
Clarithromycin Structure
API-
- VOQUEZNA TRIPLE PAK – Vonoprazan, Amoxicillin, Clarithromycin
- VOQUEZNA DUAL PAK – Vonoprazan, Amoxicillin
VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. PCABs are a novel class of medicines that block acid secretion in the stomach.
Amoxicillin structure
Vonoprazan has shown the potential to provide acid suppression that can achieve pH levels that are important in enhancing antibiotic effectiveness.
Vonoprazan, is a novel, potassium-competitive acid blocker (P-CAB) that binds and inhibits H-K ATPase, the final step in acid secretion from the parietal cells of the stomach. It can inhibit the proton pump in both acidic and neutral environments with high affinity.
Vonoprazan structure
Phathom in-licensed the U.S., European, and Canadian rights to vonoprazan from Takeda, which completed 19 Phase 3 trials for vonoprazan and received marketing approval in Japan and numerous other countries in Asia and Latin America.
Indication and Important Safety Information
INDICATIONS AND USAGE
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. VOQUEZNA™ DUAL PAK™ is a co-packaged product containing vonoprazan and amoxicillin. Both products are indicated for the treatment of Helicobacter pylori infection in adults.
CONTRAINDICATIONS
VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with known hypersensitivity to vonoprazan or amoxicillin, any other components of the formulation, any other beta-lactams, or in patients receiving rilpivirine-containing products.
Due to the clarithromycin component, VOQUEZNA TRIPLE PAK is also contraindicated in patients with any known hypersensitivity to clarithromycin or any macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in patients with renal or hepatic impairment, or those with a history of cholestatic jaundice/hepatic dysfunction.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) include diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis.
DRUG INTERACTIONS
Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK have the potential for clinically important drug interactions. See full Prescribing Information for important drug interactions.
Voquezna Triple Pak and Voquezna Dual Pak were both given the green light to treat Helicobacter pylori (H. pylori). The products’ New Drug Applications had been granted priority review and also designated as Qualified Infectious Diseases Products.
Voquezna Triple Pak is made up of vonoprazan tablets, amoxicillin capsules and clarithromycin tablets, while the Dual Pak consists of vonoprazan tablets and amoxicillin capsules. Both are designed to address the H. pylori bacterial pathogen, which can lead to serious complications like non-cardia gastric cancer and peptic ulcer if left untreated. There are around 115 million people affected by this pathogen in the U.S. and eradication rates are below 80%.
Vonoprazan, a potassium-competitive acid blocker, is the first innovative acid suppressant from a new drug classification in the U.S. over the last three decades.
“As a practicing physician, I am excited about the potential of two novel first-line H. pylori treatment options,” said William D. Chey, MD, of the University of Michigan in Ann Arbor, in a press release. “I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection.”
For the overall study population, the H. pylori eradication rate was 80.8% with the vonoprazan-based triplet and 77.2% with the doublet versus 68.5% with lansoprazole triple therapy, while those with a clarithromycin-resistant strain had slightly lower rates (65.8%, 69.6%, and 31.9%, respectively).
About Helicobacter pylori (H. pylori) infection
H. pylori is a bacterial pathogen that is estimated to infect nearly 115 million individuals in the United States. Approximately 50% of the world and 36% of the U.S. population is estimated to be infected with the bacterium. As a result of the chronic inflammation induced by H. pylori infection, infected patients may develop a range of pathologies including dyspepsia, peptic ulcer disease, non-cardia gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Studies have found that roughly 1 in 4 patients treated for H. pylori will fail first-line therapy when using PPI-based clarithromycin triple therapy
About Phathom Pharmaceuticals, Inc.
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). Vonoprazan-based regimens are approved in the U.S. as part of a co-packaged product in combination with antibiotics for the treatment of H. pylori infection in adults, marketed as VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin). Phathom has submitted a New Drug Application to the FDA for vonoprazan in erosive esophagitis (EE) and is studying the use of vonoprazan for the treatment of non-erosive reflux disease (NERD).