Cluster Headache

One in four households in America has a member with migraine, according to the American Migraine Foundation. Image credit: Shutterstock / Art_Photo. Amneal Pharmaceuticals has submitted another new drug application (NDA) for its dihydroergotamine (DHE) prefilled syringe autoinjector to treat tough-to-treat headaches, after being previously rejected. The resubmitted filing to the US Food and Drug Administration (FDA) addresses manufacturing concerns raised by the agency when it issued Amneal a complete response letter (CRL). A review of the NDA, which is for the acute treatment of migraine with or without aura and cluster headache in adults, is expected to be completed in Q2 2025, as per a 21 November press release. Amneal has not publicly disclosed when the CRL was issued and did not immediately reply to Pharmaceutical Technology when asked for confirmation of the date. The company has only stated that the rejection was due to “facility inspection issues at a third-party site”. The company has since moved production of the compound in-house to address this. DHE is an established medication used to treat migraines and cluster headaches. It is sold under brand names such as Migranal, Trudhesa, and D.H.E 45, where administration is via nasal spray or injection. If approved, Amneal’s product would be the first and only DHE autoinjector on the market. The drugmaker says the single-dose, ready-to-use pen would not require refrigeration, assembly, or priming, and allow more convenient dosing. The market opportunity for an autoinjector is hard to quantify due to the number of DHE products currently on the market, but Amneal estimates a “$50m to $100m US sales opportunity”, based on a company presentation from June 2024. One in four households in America has a household member who suffers migraine, according to the American Migraine Foundation. Amneal’s speciality chief commercial officer Joe Renda said: “We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches. [The product] provides lasting relief for tough-to-treat headaches, in a single-dose autoinjector without the need for assembly or travelling to the emergency room during these painful episodes.” Amneal hasn’t been the only one to fall short of FDA approval for acute migraine treatment, US-based Satsuma Pharmaceuticals received a CRL in January this year relating to chemistry, manufacturing, and control (CMC) issues with its DHE candidate STS101. In the same release announcing its NDA resubmission, Amneal also reported it has received FDA approval for exenatide – a generic injectable glucagon-like peptide-1 receptor agonist (GLP-1RA). The approval is for the 1.2ml and 2.4ml prefilled pen injections that reference AstraZeneca ’s Byetta.

BRIDGEWATER, N.J.--( BUSINESS WIRE )--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations. Resubmission of DHE Autoinjector New Drug Application This first and only DHE autoinjector has the potential to provide patients with lasting pain relief from tough-to-treat headaches, particularly cluster headaches, with the same powerful medication used in hospitals. The single-dose, ready-to-use autoinjector will not require refrigeration, assembly, or priming, and allow patients to conveniently self-administer at home when experiencing painful attacks. The U.S. FDA previously issued a complete response letter to the original NDA, citing facility inspection issues at a third-party site. As a result, Amneal transferred production to in-house and leveraged its expertise in complex injectable manufacturing and engineering to complete development of this new product. The review of this NDA is expected to be completed in the second quarter of 2025. “We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches. This is a unique product that can allow patients to self-administer DHE, which is a proven therapy that provides lasting relief for tough-to-treat headaches, in a single-dose autoinjector without the need for assembly or traveling to the emergency room during these painful episodes,” said Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. Over 39 million Americans are living with migraines (1) , and up to one million with cluster headaches. (2) Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States. (3) U.S. FDA Approval of Exenatide, an Injectable GLP-1 Agonist The approval of exenatide 1.2 mL and 2.4 mL prefilled pen injection, referencing BYETTA ® , reflects the Company’s deep innovation and regulatory capabilities in complex pharmaceuticals and its ability to successfully develop this first synthetic generic peptide. Exenatide is a GLP-1 agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. “This approval marks one of the first generic GLP-1 injectables to be approved in the U.S. Exenatide is a peptide drug-device combination product that is complex to develop and make. Amneal is leveraging its leading product development and manufacturing capabilities in the rapidly growing GLP-1 therapeutic category,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. Patients have experienced changes in kidney function, low blood sugar, and inflammation of the pancreas while using exenatide. The most common side effects include nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness. For complete prescribing information, please refer to the package insert available here . About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. References (1) https://migraineresearchfoundation.org/about-migraine/migraine-facts/ (2) https://americanmigrainefoundation.org/resource-library/cluster-headache-2/ (3) Zodda D, Procopio G, Gupta A. Evaluation and management of life-threatening headaches in the emergency department. Emerg Med Pract. 2019 Feb;21(2):1-20. Epub 2019 Feb 1. PMID: 30676714. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/30676714/

VANCOUVER, British Columbia & STUART, Fla.--( BUSINESS WIRE )-- Lobe Sciences, Ltd. ("Lobe Sciences" or the "Company") (CSE: LOBE), (OTCQB: LOBEF) and Alera Pharma, Inc. (“Alera” or “Alera Pharma”) , biopharmaceutical companies focused on developing products to treat diseases with significant unmet medical needs, today announce that a second patent allowance for Conjugated Psilocin™ has been received. The patent application is entitled “Stable Psilocin Salts, Esters, and Conjugates and Uses Thereof”. This application contains claims covering compositions comprising a psilocin mucate salt or conjugate and methods for their production and use in conditions treatable with psilocin. Lobe Sciences will assign the intellectual property rights associated with this patent to Alera Pharma, its wholly owned subsidiary. Mr. Rick Goulburn, CEO of Alera Pharma, Inc. stated, “we are excited to receive this allowance for a second patent on Conjugated Psilocin™ which recognizes the unique properties of this psilocin analogue invention. We are proceeding with our fund-raising activities to develop Conjugated Psilocin™ for the treatment of Chronic Cluster Headache.” Dr. Fred Sancilio, Chairman and CEO of Lobe Sciences also commented, “As we continue to gather more data on Conjugated Psilocin™, we realize that this new chemical entity may enable us to develop a wide range of applications.” He continued, “Conjugated Psilocin™ is a stable form of psilocin, the active metabolite of psilocybin with attractive pharmacokinetics including rapid and reproducible absorption. Both these attributes may make this active ingredient superior to psilocybin itself.” About Conjugated Psilocin ™ Conjugated Psilocin™ is a patented, novel, oral, stable analogue of psilocin, the active metabolite of the prodrug psilocybin. Psilocybin is a psychedelic compound that has been identified as having therapeutic potential in a variety of neurological conditions. Psilocybin is dephosphorylated to the active moiety psilocin with poor bioavailability and pharmacokinetics. Psilocin itself is a very unstable compound that has been difficult to develop as a pharmaceutical medicine. Conjugated Psilocin™ is a stable, highly bioavailable pharmaceutical ingredient with the potential to be developed as a prescription medicine in a variety of neurological disorders. About Lobe Sciences Ltd. Lobe Sciences, Ltd. is a commercial stage biotechnology company focused on developing transformative therapies for unmet medical needs. Through its subsidiaries, Alera Pharma, Inc. and Altemia, Inc., Lobe Sciences is developing patented drug candidates to treat chronic cluster headache (Alera) and innovative medical foods to address deficiencies commonly seen in sickle cell disease (Altemia). Lobe Sciences provides common services to its subsidiaries including accounting, finance, and general administrative services. About Alera Pharma, Inc . Alera Pharma, Inc. is a wholly owned and private subsidiary of Lobe Sciences, Ltd., dedicated to the development and commercialization of innovative pharmaceutical products. With a focus on addressing unmet medical needs, Alera Pharma is committed to improving patient outcomes in a variety of neurological disorders through cutting-edge research and development. Cautionary Statement Regarding "Forward-Looking" Information This news release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, including statements regarding future estimates, plans, objectives, timing, assumptions or expectations of future performance, including, without limitation: the additional coverage provided by the new patent; the anticipated assignment of the intellectual property rights associated with the new patent; the expected fund-raising activities of the Company; and the Company’s beliefs regarding potential applications of Conjugated Psilocin™, are forward-looking statements and contain forward-looking information. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as “intends” or “anticipates”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should” or “would” or occur. Forward-looking statements are based on certain material assumptions and analysis made by the Company and the opinions and estimates of management as of the date of this press release, including, among other things, that: once issued, the new patent will provide additional coverage for psilocin mucate compositions; that Lobe Sciences will assign the intellectual property rights associated with the new patent to Alera Pharma; that the Company will proceed with its expected fund-raising activities, and that the proceeds therefrom will be used to develop Conjugated Psilocin™ for the treatment of Chronic Cluster Headache; and that Conjugated Psilocin™ may enable the Company to develop a wide range of applications. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. Important risks that may cause actual results to vary, include, without limitation, the risk that: the Company will not receive a second patent for Conjugated Psilocin™; that the new patent will not provide additional coverage for psilocin mucate compositions; that Lobe Sciences will not assign the intellectual property rights associated with the new patent to Alera Pharma, or at all; that the Company will not proceed with its fund-raising activities, or that the proceeds from the Company’s fund-raising activities will not be used to develop Conjugated Psilocin™ for treatment of Chronic Cluster Headaches; and that Conjugated Psilocin™ may not enable the Company to develop a wide range of applications. Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws.