Vazalore (aspirin-PC) / PLx Pharma - LARVOL DELTA

Pharmacodynamic Comparison of Two Aspirin Formulations in the Caribbean: The ARC Study. (PubMed, Cardiol Ther) - P2 | "There were no significant differences in aspirin resistance between Bayer® LD EC-ASA and Vazalore® LD PL-ASA. This dedicated pharmacodynamic study could potentially be informative and applicable for Trinidadian patients on dual antiplatelet therapy (DAPT). Further studies are required to confirm these exploratory findings."

Journal • PK/PD data

Pharmacological Efficacy and Gastrointestinal Safety of Different Aspirin Formulations for Cardiovascular Prevention: A Narrative Review. (PubMed, J Cardiovasc Dev Dis) - "Although interesting, the results of experiments on the phospholipid-aspirin complex PL2200 are still preliminary. Considering its favorable pharmacological profile, plain aspirin should be the preferred formulation to be used for cardiovascular prevention."

Journal • Review • Cardiovascular • CNS Disorders • Coronary Artery Disease • Diabetes • Essential Thrombocythemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Metabolic Disorders • Myeloproliferative Neoplasm • Thrombocytosis • Vascular Neurology

PLx Pharma Inc. Enters into a Stalking Horse Asset Purchase Agreement to Sell VAZALORE and Substantially All of its Assets (GlobeNewswire) - "PLx Pharma Inc....and patent-protected PLxGuard™ and VAZALORE®, an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. The Company today announced that it entered into a stalking horse asset purchase agreement (the 'APA') with PLx Acquisition Company, LLC, a wholly-owned subsidiary of Greenwood Brands, LLC ('Buyer'), to acquire substantially all of the Company’s assets (the 'Sale'). The Company intends to file voluntary petitions for relief under Chapter 11 of Title 11 of the U.S. Code in the U.S. Bankruptcy Court for the District of Delaware (the 'Bankruptcy Court') within the next two business days. The Sale would also be subject to higher and better offers the Company may receive during an auction process. Pursuant to the terms and subject to the conditions of the APA, the purchase price is $100,000 in cash, plus a credit bid of $3 million, plus Buyer’s assumption of certain liabilities."

M&A • Cardiovascular • Pain

"@CMichaelGibson plx pharma struggling. Are you still an advocate of Vazalore?" (@Baka18944)

Development of the PC-NSAID technology: from contact angle to Vazalore®. (PubMed, Drug Discov Today) - "Finally, we discuss the commercialization and launch of Aspirin-PC, an over-the-counter (OTC) drug with the brand name Vazalore®. Teaser: We review the development, from bench experiments to clinical trials, of the first FDA-approved phosphatidylcholine (PC)-associated NSAID, Aspirin-PC, which was launched under the brand name Vazalore® in August 2021."

Journal • Basal Cell Carcinoma • Gastrointestinal Disorder • Immunology • Inflammation

"Do you still believe Vazalore addresses unmet needs?" (@Baka18944)

Pharmacokinetic and pharmacodynamic profiles of a novel phospholipid-aspirin complex liquid formulation and low dose enteric-coated aspirin: results from a prospective, randomized, crossover study. (PubMed, J Thromb Thrombolysis) - P4 | "PL-ASA resulted in faster and more complete aspirin absorption paralleled by more prompt and potent platelet inhibition compared with EC-ASA after a single 81 mg dose. PL-ASA represents an attractive novel aspirin formulation for the secondary prevention of cardiovascular events.Clinical Trial Registration ClinicalTrials.gov identifier: NCT04811625."

Journal • PK/PD data • Cardiovascular • Gastrointestinal Disorder

"Are you a believer of Vazalore?" (@Baka18944)

Will the new pharmaceutical lipid-aspirin complex formulation restore the once lost trust of aspirin on cardiovascular protection? (PubMed, Postgrad Med) - "Over the years the goal of delivering therapeutic levels of aspirin (ASA) while reducing the risk of gastrointestinal (GI) injury has been the main goal. The novel concept of the pharmaceutical lipid-aspirin complex (PL-ASA) is supposed to produce more rapid and more extensive absorption in obese patients with type 2 diabetes.While initial data is certainly encouraging, it is important to keep in mind that none of pharmacokinetic and pharmacodynamic studies went beyond 7-days, thus the effects of chronic administration, which can alter the ASA pharmacodynamic response, remain unknown.In the meantime, television advertisements and other means are reaching audiences and encourage them to start using this product.Our Editorial raises questions and is trying to raise concerns to healthcare providers so their patients patiently wait for confirmation data that will eventually allow us to freely utilize this promising product in patients at risk of adverse cardiovascular events..."

Journal • Cardiovascular • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Myocardial Infarction • Obesity • Peptic Ulcer • Type 2 Diabetes Mellitus

Vazalore - A new aspirin formulation. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Pharmacodynamic and Pharmacokinetic Study of PL-ASA (clinicaltrials.gov) - P4 | N=36 | Completed | Sponsor: PLx Pharma | Active, not recruiting ➔ Completed

Trial completion

Pharmacokinetic and Pharmacodynamic Profile of a Novel Phospholipid Aspirin Formulation. (PubMed, Clin Pharmacokinet) - "It is associated with reduced local acute GI injury compared with plain aspirin, and predictable absorption resulting in more reliable platelet inhibition compared with enteric-coated tablets. This review explores the rationale and pharmacologic profile of PL-ASA intended to address the unmet needs for aspirin therapy."

Journal • PK/PD data • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Gastrointestinal Disorder

"The effect / safety impact of PPI is much greater than the delta of Vazalore vs aspirin" (@Adrian_H)

Clinical

"$PLXP PLx Pharma Inc. Provides VAZALORE Launch Update https://t.co/7ZFZXiPb7Z" (@stock_titan)

"$PLXP PLx Pharma Inc.’s VAZALORE to Launch in over 8,000 Walgreens Stores Nationwide in August https://t.co/qdGoXNYn6F" (@stock_titan)

The Influence of Lipid Excipients on Platelet Function and the Pharmacodynamic Effects of Aspirin. (PubMed, J Cardiovasc Pharmacol) - "The combination of pharmaceutical lipid excipients with aspirin in a novel liquid oral formulation (Vazalore) limits gastrointestinal toxicity of aspirin. The excipients did not activate platelets in the absence of agonist and did not alter activation of platelets in response to adenosine diphosphate, arachidonic acid, thrombin, or convulxin (a collagen mimetic). Lipid excipients used in an oral formulation of aspirin do not impair the pharmacodynamic effects of aspirin and do not alter platelet function."

Journal • PK/PD data • Gastrointestinal Disorder

Interpreting Data From the COMPASS and ATLAS ACS 2-TIMI 51 Trials (MD Magazine) - "Deepak L. Bhatt, MD, MPH: We can pivot now and talk about some of the newest data from the COMPASS and VOYAGER PAD trials. I’ll make a few comments about COMPASS. The overall results of the COMPASS trial, of course, have been presented and published....The winner was aspirin plus a vascular dose of rivaroxaban. Aspirin at a low dose plus rivaroxaban at 2.5 mg twice a day significantly reduced cardiovascular events, including a significant reduction in all-cause mortality and certainly in CV [cardiovascular] mortality."

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