Varenicline Tartrate

THURSDAY, June 6, 2024 -- Popular smoking cessation aids are equally effective in those with or without a history of mental health conditions, according to a study published online June 4 in PLOS Mental Health . Sarah E. Jackson, Ph.D., from University College London, and colleagues examined whether the real-world effectiveness of popular smoking cessation aids differs between users with and without a history of mental health conditions. The analysis included 5,593 adults (2,524 with a history of at least one mental health condition) who had smoked regularly within the past year and had attempted to quit at least once in the past year. The researchers found that participants with a history of mental health conditions were significantly more likely to report using vaping products (38.8 versus 30.7 percent without a mental health condition), prescription nicotine replacement therapy (4.8 versus 2.7 percent), and websites (4.0 versus 2.2 percent). When adjusting for covariates and use of other cessation aids, those who used vaping products (odds ratio [OR], 1.92), varenicline (OR, 1.88), or heated tobacco products (OR, 2.33) had significantly higher odds of quitting successfully compared with those who did not report using these aids. "In conclusion, use of vaping products, varenicline, or heated tobacco products in a quit attempt was associated with significantly greater odds of successful cessation, after adjustment for use of other cessation aids and potential confounders," the authors write. "There was no evidence to suggest the effectiveness of any popular cessation aid differed according to the user’s history of mental health conditions." Two authors disclosed ties to Pfizer and J&J, which manufacture smoking cessation medications. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MALVERN, Pa., May 30, 2024 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company"), a newly formed entity that recently acquired (the "Acquisition") substantially all of the assets of Endo International plc ("EIP") as contemplated by EIP's plan of reorganization (the "Plan"), today made select first-quarter 2024 financial results for EIP available to investors. EIP's first-quarter financial results were in-line with its previously provided expectations. Endo is providing the following historical financial information of EIP because, from Endo's formation through March 31, 2024, it had no operations, business transactions or activities other than those incidental to its formation or taken in contemplation of the Plan (including the Acquisition). Endo had no other assets or liabilities during the periods presented in this release. The following historical financial information of EIP does not give effect to the transactions contemplated by the Plan or the application of fresh start accounting expected to apply to Endo's financial information beginning in the second quarter of 2024. EIP FIRST-QUARTER FINANCIAL PERFORMANCE (in thousands) EIP CONSOLIDATED FINANCIAL RESULTS Total revenues were $420 million in first-quarter 2024, a decrease of 19% compared to $515 million in first-quarter 2023. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals segment. Reported Net Loss in first-quarter 2024 was $154 million compared to reported Net Loss of $3 million in first-quarter 2023. This change was primarily due to increased expenses related to the Chapter 11 reorganization process and decreased revenues. Adjusted Net Income in first-quarter 2024 was $131 million compared to $193 million in first-quarter 2023. This change was primarily driven by decreased revenues. BRANDED PHARMACEUTICALS SEGMENT First-quarter 2024 Branded Pharmaceuticals segment revenues were $201 million compared to $198 million during first-quarter 2023. Specialty Products revenues increased 4% to $148 million in first-quarter 2024 compared to $142 million in first-quarter 2023. This change was primarily due to an increase in XIAFLEX® revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower volumes. First-quarter 2024 XIAFLEX® revenues were $113 million, an increase of 17% compared to $97 million during first-quarter 2023 driven by increased net selling price and increased volumes. STERILE INJECTABLES SEGMENT First-quarter 2024 Sterile Injectables segment revenues were $98 million, a decrease of 3% compared to $101 million during first-quarter 2023. This decrease was primarily attributable to competitive pressure on a number of products and was partially offset by increased VASOSTRICT® and ADRENALIN® revenues driven by higher volumes. GENERIC PHARMACEUTICALS SEGMENT First-quarter 2024 Generic Pharmaceuticals segment revenues were $103 million, a decrease of 48% compared to $198 million during first-quarter 2023. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and dexlansoprazole delayed release capsules, the generic version of Dexilant®, partially offset by increased revenues from lidocaine patch 5%, the generic version of LIDODERM®. INTERNATIONAL PHARMACEUTICALS SEGMENT First-quarter 2024 International Pharmaceuticals segment revenues were $17 million compared to $18 million during first-quarter 2023. CASH, CASH FLOW AND OTHER UPDATES As of March 31, 2024, EIP had approximately $641 million in unrestricted cash and cash equivalents. First-quarter 2024 net cash provided by operating activities was approximately $26 million compared to approximately $62 million net cash provided by operating activities during first-quarter 2023. This change was primarily driven by decreased revenues. 2024 FINANCIAL EXPECTATIONS Endo is providing financial guidance for the full-year ending December 31, 2024, which guidance includes EIP's financial results prior to the Acquisition. All expectations provided by Endo, which are unchanged from expectations previously provided by EIP, are forward-looking and actual results may differ materially and adversely from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo will host a conference call to discuss this press release tomorrow, May 31, 2024, at 8:30 a.m. ET for registered holders of its debt and equity securities. There are three ways to join the call: Phone link to register and receive an automatic callback when conference call begins: Phone dial-in number with operator support: 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 Webcast: Please dial in 10 minutes prior to the scheduled start time. Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc. Chantix® is a registered trademark of Pfizer Inc. LIDODERM® is a registered trademark of Endo, Inc. FINANCIAL SCHEDULES The following table presents Endo International plc's unaudited Total revenues, net for the three months ended March 31, 2024 and 2023 (dollars in thousands): The following table presents unaudited Condensed Consolidated Statement of Operations data of Endo International plc for the three months ended March 31, 2024 and 2023 (in thousands): The following table presents unaudited Condensed Consolidated Balance Sheet data of Endo International plc at March 31, 2024 and December 31, 2023 (in thousands): The following table presents unaudited Condensed Consolidated Statement of Cash Flow data of Endo International plc for the three months ended March 31, 2024 and 2023 (in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo International in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the three months ended March 31, 2024 and 2023 (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of the Endo International plc's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) for the three months ended March 31, 2024 and 2023 (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo International between the GAAP and non-GAAP amounts for the three months ended March 31, 2024 and 2023 (in thousands, except per share data): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures SEC Review Endo has confidentially submitted a draft registration statement with the U.S. Securities and Exchange Commission (the "SEC") to effectuate its previously announced goal of listing its common stock on a national stock exchange. The registration statement includes a description of Endo's business, financial and other information, some of which is included in this press release. Comments by the SEC on the registration statement may require modification or reformulation of the description of Endo's business. As a result, financial information that Endo presents in the future may differ in presentation or calculation from the information presented herein. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This release includes certain statements, claims, estimates, predictions and other information prepared and provided by Endo with respect to the anticipated future performance of Endo and its subsidiaries. Such statements include or are based on "forward looking statements" including, but not limited to, statements relating to financial expectations or guidance and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the effects of the emergence of EIP's operating assets from the Chapter 11 financial restructuring process, including as it relates to the accounting for the effects of the Plan and the application of fresh start accounting; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of any strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. SOURCE Endo, Inc. SOURCE Endo, Inc.