Acetaminophen

Jan. 27, 2025 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, announced today it was issued a new U.S. Patent No. 12,180,174 entitled “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF” from the United States Patent and Trademark Office (USPTO) for its U.S. Patent Application Serial Number USSN: 17/978,818. This new patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders. Anavex’s newest patent will be expected to remain in force at least until July 2039, not including any patent term extensions. It will expand and supplement the current ANAVEX®2-73 (blarcamesine) patent portfolio, which includes several U.S. Patents, including U.S. Patent Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908. “The issuance of this U.S. Patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We believe the unique properties of the dihydrogen phosphate crystals make it possible in addition to convenient once daily oral dosing to also deliver the active (ANAVEX®2-73 freebase) in transdermal patches, which could simplify further the administration and boost patients’ compliance. As such, we believe that the addition of the dihydrogen phosphate crystals to our platform could greatly benefit the patients at large.” Crystal polymorphism is a unique phenomenon related to chiral compounds, wherein the compounds may crystallize into different crystal structures or crystal forms under different conditions and/or processes. Specifically for pharmaceuticals, polymorphic forms of drug substances ‘exist in different crystalline forms which differ in their physical properties’.1 These property differences may result in direct medical implications, such as ease of formulation, increased efficacy, and reduced side effects. For example, the widely used analgesic drug, acetaminophen has three polymorphic forms, I, II, and III, among which only Form I is made into commercial dosage forms as the other two forms are either meta-stable or unstable.2 Nonetheless, uncovering an optimal crystal form is NOT an easy or straightforward task, because there are so many variables and possibilities involved, and chance of success lies heavily on the researcher’s experience and insights into the compounds in question. Both ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 have the potential to form different crystal forms. Through its deep understanding and abundance experience with these two compounds, Anavex was successful in discovering crystal forms of ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 that have advantageous physiochemical and/or pharmacological properties. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. 1 ICH HARMONISED TRIPARTITE GUIDELINE, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES Q6A, Current Step 4 version dated 6 October 1999, page 8. 2 Lee E.H., “A practical guide to pharmaceutical polymorph screening & selection,” Asian Journal of Pharmaceutical Sciences, Vol 9, Issue 4, August 2014, Pages 163-175. The content above comes from the network. if any infringement, please contact us to modify.

A novel Vertex Pharmaceuticals drug that takes a new approach to pain is now approved by the FDA, a landmark decision for a first-in-class product that brings patients a treatment alternative intended to avoid the addiction risks posed by opioid medications. The regulatory decision announced late Thursday covers the treatment of moderate-to-severe acute pain in adults. Acute pain is defined as pain that lasts less than three months, such as aches following an injury or a surgical procedure. The Boston-based company’s new drug, a twice-daily pill known in development as suzetrigine, will be marketed under the brand name Journavx. “Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s approval announcement. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.” Exclusive Improving the Healthcare Financial Experience to Help Care Flow Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. By Stephanie Baum The addiction risks of opioids come from their targeting of receptors in the central nervous system. But before pain signals reach the brain, they travel across pathways in the peripheral nervous system. Journavx targets one of these pathways, a sodium channel called NaV1.8. The drug is a small molecule designed to selectively block this channel without hitting other related sodium channels, which could lead to adverse effects. The drug comes from a pain research program that began at Vertex about 25 years ago. FDA approval of Journavx is based on the results of two Phase 3 studies, one that tested the drug after abdominoplasty (tummy tuck) surgery and the other after bunionectomy surgery. Both studies met the main goal of showing statistically significant improvement compared to placebo according to a pain rating scale. The studies also included as a comparator the drug Vicodin, an inexpensive painkiller that pairs the opioid hydrocodone with the main pharmaceutical ingredient in Tylenol. On this secondary trial measure, the results were disappointing. In tummy tuck patients, the numerical improvement achieved by suzetrigine fell short of statistical significance compared to Vicodin. In bunion surgery patients, Vicodin beat suzetrigine. The Vertex drug was safe and well tolerated in these studies. Vertex reported no addiction problems in the studies. Vertex is also developing Journavx for chronic pain, but there have been mixed results so far. In a Phase 2 test in painful lumbosacral radiculopathy (lower back pain), data released last month showed that despite meeting the main goal according to a pain rating scale, the placebo arm posted a similar response. The study was not powered or designed to show differentiation from placebo, but Vertex’s stock price still took a hit. The company said it plans to advance the drug to a pivotal test in this indication, pending discussions with regulators. A Phase 3 test in painful diabetic peripheral neuropathy is ongoing. In a note sent to investors after the back pain trial readout, William Blair analyst Myles Minter said the lack of separation from placebo in that trial increases the risk for the ongoing Phase 3 diabetic peripheral neuropathy test. presented by Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum Vertex set a $15.50 per pill price for Journavx. That’s slightly higher than the $12 per pill price that Leerink Partners modeled. A December report by the Institute for Clinical and Economic Review concluded that compared to treatment with Vicodin, the Vertex drug would lead to savings that mainly come from avoiding the excess healthcare costs associated with opioid use disorder. A recent regulatory change should support reimbursement of the new Vertex product. The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act took effect on Jan. 1, requiring Medicare to provide separate reimbursement for qualifying non-opioid pain drugs. A goal of the legislation is to increase access to alternative pain drugs to reduce opioid use. Leerink analyst David Risinger wrote in a research note that the Journavx label represents the best-case scenario for Vertex. There is no language for addiction or abuse potential, which Leerink expects will be critical to the drug’s utilization. The firm sees Journavx as the first in a series of novel non-opioid pain medicines coming from Vertex. Risinger said Leerink projects Journavx and follow-on NaV1.8 inhibitors for acute and neuropathic pain could top $10 billion in peak sales. That’s important for Vertex, which is working to diversify its portfolio beyond the cystic fibrosis products that currently bring in the vast majority of its revenue. Photo by Vertex Pharmaceuticals