Latest news with #bioequivalence
National Post
2 days ago
- Health
- National Post
Alpha Cognition to Present ZUNVEYL® (Benzgalantamine) Study Data at Alzheimer's Association International Conference
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' or the 'Company'), a commercial-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced it will present new clinical data on ZUNVEYL at the Alzheimer's Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada. The Company will share the following poster presentations: Article content Bioequivalence of ZUNVEYL Article content Article content , a Galantamine Prodrug to Galantamine Hydrobromide Extended-Release Demonstrated Under Article content Steady State Article content Conditions (Poster #107147) – July 27 Article content Bioequivalence of ZUNVEYL Article content , a Galantamine Prodrug to Galantamine Hydrobromide Immediate-Release Demonstrated Under Article content Fed and Fasting Conditions Article content (Poster#107030) – July 28 Article content , a Galantamine Prodrug, Over a Dosage Range of Five to Fifteen Milligrams Demonstrated Under Fasting Conditions (Poster #107255) -July 30 Article content 'We are excited to present data demonstrating ZUNVEYL's bioequivalence and dose proportionality,' said Dr. Denis Kay, Chief Scientific Officer of Alpha Cognition. 'Given the high unmet need and challenges with current treatments, ZUNVEYL has the potential to offer physicians a well-tolerated therapy with compelling clinical benefits.' Article content AAIC is the world's largest forum for dementia research, convening global leaders in basic and clinical science to advance prevention, diagnosis, and treatment of Alzheimer's disease. Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ALPHA-1062 formulated as a delayed release oral tablet (ZUNVEYL), is an FDA approved new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Article content ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. Article content IMPORTANT SAFETY INFORMATION Article content CONTRAINDICATIONS Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. Article content WARNINGS AND PRECAUTIONS Article content Serious Skin Reactions Article content : Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Article content Anesthesia Article content Cardiovascular Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Article content Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Article content Gastrointestinal Conditions Article content : Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Article content Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Article content Genitourinary Conditions: Article content Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Article content Neurological Conditions: Article content Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Article content Pulmonary Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. Article content ADVERSE REACTIONS Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content DRUG INTERACTIONS Article content Use with Anticholinergics: Article content Galantamine has the potential to interfere with the activity of anticholinergic medications. Article content Use with Cholinomimetics and Other Cholinesterase Inhibitors: Article content A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. Article content USE IN SPECIFIC POPULATIONS Article content Pregnancy: Article content Based on animal data may cause fetal harm. Article content Hepatic Impairment: Article content In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Article content Renal Impairment: Article content In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the, the long-term benefits of ZUNVEYL, the Company's timing and planned activities and business strategy to launch ZUNVEYL, the potential timing for the availability of ZUNVEYL, the potential future developments of ZUNVEYL, the market size and demand for ZUNVEYL and the Company's potential growth opportunities, capital requirements. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks related to our focus on the long-term care market, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on January 10, 2025 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. 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Associated Press
16-06-2025
- Business
- Associated Press
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
Northvale, New Jersey--(Newsfile Corp. - June 16, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ('Elite' or the 'Company'), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug product. IQVIA reported branded product sales for the twelve months ending April 2025 of $27 billion. There is no generic product on the market, and the brand has an unexpired patent listed in the Orange Book. Commercialization of a generic product depends on successful filing, FDA approval and addressing the unexpired patent. The studies conducted were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence studies in normal, healthy, adult, human subjects under fasting conditions. The results indicated that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration. About Elite Pharmaceuticals, Inc. Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. Contact: Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations 518-398-6222 [email protected] To view the source version of this press release, please visit
