Chronic Pain

Patent expected to be Orange Book listable, if granted NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression WILMINGTON, Del., May 5, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. Continue Reading HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the Company's recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRx advances its commercialization strategy. "We are committed to delivering safer, more effective treatments for patients with suicidal depression," said Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need." About NRx Pharmaceuticals, Inc.NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Inc.HOPE Therapeutics, Inc. (), a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima and Dura, and obtaining financing necessary to consummate the acquisitions. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including the risk that the transactions contemplated by the LOI are not consummated, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, HOPE Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off HOPE Therapeutics. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE NRx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Addition of Quell® Platform Broadens electroCore’s Bioelectronic Technology Portfolio and Accelerates Growth in Chronic Pain and Wellness MarketsROCKAWAY, N.J., May 02, 2025 (GLOBE NEWSWIRE) -- electroCore, Inc. (“ECOR,” “electroCore,” or the “Company”) (Nasdaq: ECOR), a commercial-stage bioelectronic technology company, announced today the completion of the merger (the “Merger”) with NeuroMetrix, Inc. (“NeuroMetrix” or “NURO”) (Nasdaq: NURO), positioning itself as a diversified leader in non-invasive health and wellness solutions. The acquisition of NeuroMetrix’s Quell® Fibromyalgia Solution expands electroCore’s portfolio of non-invasive bioelectronic therapies, strengthens its commercial reach — particularly within the VA Hospital System — and is expected to meaningfully increase its addressable market for the treatment of chronic pain and wellness conditions. Dan Goldberger, CEO of electroCore, Inc. commented, "With this transaction now closed, we are well-positioned to immediately leverage our established distribution channels, particularly within the VA Hospital System, to accelerate adoption of the Quell Fibromyalgia solution. This addition meaningfully expands our addressable market and diversifies our portfolio of non-pharmaceutical, non-invasive nerve stimulation offerings, strengthening electroCore’s position as a leading publicly traded bioelectronic technology platform focused on wellness and chronic pain management." Under the terms of the Merger Agreement dated December 17, 2024 and approved by NeuroMetrix’s stockholders at a Special Meeting held on March 21, 2025: Each share of NURO common stock, outstanding immediately prior to the closing was converted into the right to receive (i) a cash payment of $4.49 per share and (ii) one contingent value right (CVR).The CVRs entitle holders to contingent cash payments based on the achievement of certain sales milestones tied to the Quell business as well as future proceeds from the disposition of NURO’s DPNCheck business, subject to the terms outlined in the CVR agreement dated May 1, 2025. As a result of the Merger, NeuroMetrix became an indirect wholly-owned subsidiary of electroCore, and NURO’s shares will be de-listed from the Nasdaq Capital Market prior to the opening of trading on May 2, 2025. Additional information on the transaction can be found in a Current Report on Form 8-K filed by electroCore, Inc. with the SEC. About electroCore, Inc.electroCore, Inc. and its subsidiaries are a commercial stage bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. For more information, visit www.electrocore.com. Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the federal securities laws, including under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements regarding the anticipated benefits of the merger with NeuroMetrix, Inc., electroCore's business prospects, its product portfolio or potential markets for its technologies, and other statements that are not historical in nature, particularly those using terminology such as "anticipates," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to obtain additional financing necessary to continue electroCore's business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize nVNS products, competition in the industry in which electroCore operates and general market conditions. Important risk factors that may cause such a difference include, but are not limited to: (i) the anticipated tax treatment of the transaction may not be obtained, (ii) the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the businesses of NeuroMetrix and electroCore after the consummation of the transactions, (iii) potential litigation relating to the proposed transaction that could be instituted against the parties or their respective directors, (iv) potential adverse reactions or changes to business relationships resulting from the completion of the transactions, (v) any negative effects of the consummation of the transactions on the market price of electroCore’s common stock and on their businesses or operating results, (vi) risks associated with third party contracts containing consent and/or other provisions that may be triggered by the proposed transaction, (vii) the risks and costs associated with the integration of, and the ability of electroCore to integrate the Quell business successfully, (viii) the risk that disruptions from the proposed transaction will harm the parties’ respective business, including current plans and operations, (ix) the ability of electroCore or NeuroMetrix to retain and hire key personnel and uncertainties arising from any business or leadership changes, (x) legislative, regulatory and economic developments, and (xi) the other risks described in electroCore’s or NeuroMetrix’s most recent annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC. No listing of risk factors should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on electroCore’s or NeuroMetrix’s consolidated financial condition, results of operations, or liquidity. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. ContactECOR Investor Relations(973) 302-9253investors@electrocore.com

FDA advisors next week will discuss the risks of long-term opioid use during a joint-committee meeting that will examine two completed post-marketing studies the agency requested more than a decade ago. The agency is convening the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee in a Monday meeting that was originally scheduled for February, but was postponed shortly after President Donald Trump took office. The FDA first approved extended-release/long-acting opioids in 1987. In 2013, based on a review of the literature, the FDA sought five additional post-marketing studies after concluding that more data were needed regarding the serious risks of misuse, abuse, addiction, overdose and death associated with long-term use. Allergan, Endo Pharmaceuticals, Hikma, Janssen Mallinckrodt, Pfizer and Purdue Pharma were among those tasked with conducting the four observational studies and one prospective clinical trial. The adcomms will review the results from two of the post-marketing studies. The FDA is calling on the outside experts to consider the findings from these studies and what is currently in FDA-approved opioid labeling, to decide whether the agency should communicate any novel findings to healthcare providers, patients and the general public. The FDA said the goal of the studies was not “to quantify the causal contribution of OA [opioid analgesic] use to these risks, but rather to examine how common these serious adverse outcomes were in this patient population, and to study a large number of potential risk factors,” the agency said in its briefing documents released Thursday ahead of the meeting. “Prescription opioid misuse (intentional use for therapeutic purposes outside label directions or other than prescribed or directed by prescriber), was common among patients with long-term use of opioid analgesics for the treatment of chronic pain,” the FDA said. The committees are slated to discuss how these studies help to elucidate the safety of long-term opioid use and estimated incidences of fatal and nonfatal overdoses in patients. The studies found that opioid overdose death estimates “were more than twice as high in populations receiving Medicaid as in those in the two commercially insured populations and one managed-care population, precluding the determination of a single risk estimate and serving as a reminder of the individual- and system-level factors that may converge to increase OA-related harms,” the FDA said. The agency also noted that while the relationships between misuse, abuse and opioid use disorder were explored in depth in the studies, they “were not entirely straightforward; because [opioid use disorder] and overdose were studied separately, it was not possible to examine the relationships between them directly.” The FDA said that since the studies were conducted, opioid prescribing and risk “have become more salient as the opioid landscape has evolved, for example, relationships between changes in dose or discontinuation of OAs and risk of overdose, suicide, or use of illicit opioids.”