Migraine

AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, April 4, 2024
Symantec Endpoint Protection, Telephone, CRL, News, NDA, CMC, Migraine, Myenteric plexus, Chemistry, P.C, Therapy, FDA, Food, Pharmaceutical industry

Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.
  • However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
  • Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome .

AEON Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 29, 2024
AEON, Steps, U.S. FDA, LTD, Headache, Patient, Migraine, Investment, Alembic Pharmaceuticals, Safety, FDA, Food, Pharmaceutical industry

IRVINE, Calif., March 29, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • We are now well-positioned to plan for the initiation of our pivotal Phase 3 program,” commented Marc Forth, AEON’s President and Chief Executive Officer.
  • “Recently, we announced plans to conduct an interim analysis of our ongoing Phase 2 study of ABP-450 as a preventive treatment for chronic migraine, which completed enrollment in December 2023.
  • On track to announce topline results from the Phase 2 study of ABP-450 as a preventive treatment for chronic migraine in the third quarter of 2024.
  • Episodic Migraine Program Next Steps – The Company is continuing to plan for the initiation of its proposed pivotal Phase 3 program for ABP-450.

AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, March 26, 2024
Symantec Endpoint Protection, Telephone, CRL, News, NDA, CMC, Migraine, Myenteric plexus, Chemistry, P.C, Therapy, FDA, Food, Pharmaceutical industry

Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.
  • However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
  • Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome .

Lundbeck to Present Data on Migraine Impact Reduction and Sustained Response with VYEPTI® (eptinezumab-jjmr) at 76th Annual Meeting of the American Academy of Neurology

Retrieved on: 
Tuesday, April 9, 2024
Health, Other Science, General Health, Clinical Trials, Research, Science, Pharmaceutical, Hypersensitivity, Anaphylaxis, Angioedema, Brain, Eptinezumab, Virtual Private LAN Service, Headache, Patient, American Academy, Interview, MD, Neurology, Migraine, Lundbeck, Quality of life, AAN, Abstract, Pharmaceutical industry

These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.

Key Points: 
  • These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.
  • “Our real-world data helps us better understand how individuals are uniquely impacted by migraine beyond monthly headache days.
  • We’re excited to continually partner with the migraine community to raise the bar on preventive treatment expectations.”
    VYEPTI is indicated for the preventive treatment of migraine in adults.
  • The safety and efficacy of VYEPTI has not been evaluated for use in any psychiatric conditions.

Caffeine Powder Market to Reach $1,612.1 Million, Globally, by 2032 at 5.5% CAGR: Allied Market Research

Retrieved on: 
Monday, April 8, 2024
Alertness, Health, Fatigue, Headache, Growth, Data, Drink, Migraine, Caffeine, Medicinal plants

WILMINGTON, Del., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Caffeine Powder Market by Source (Synthetic Caffeine, Natural Caffeine), and Application (Food and Beverages, Pharmaceuticals, Cosmetics and Personal Care, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "caffeine powder market" was valued at $949.4 million in 2022, and is estimated to reach $1,612.1 million by 2032, growing at a CAGR of 5.5% from 2023 to 2032.

Key Points: 
  • Moreover, caffeine powder offers consumers the flexibility to customize their caffeine intake according to their preferences and needs.
  • In addition, the globalization of the caffeine powder market has led to increased accessibility and availability of products across regions and channels.
  • Furthermore, Europe is home to several prominent pharmaceutical and food industries that utilize caffeine powder in various formulations, further bolstering market growth.
  • With its robust market infrastructure, consumer demand, and regulatory framework, Europe is expected to maintain its leadership position in the global caffeine powder market.

Caffeine Powder Market to Reach $1,612.1 Million, Globally, by 2032 at 5.5% CAGR: Allied Market Research

Retrieved on: 
Monday, April 8, 2024
Alertness, Health, Fatigue, Headache, Growth, Data, Drink, Migraine, Caffeine, Medicinal plants

WILMINGTON, Del., April 8, 2024 /PRNewswire/ -- Allied Market Research published a report, titled, "Caffeine Powder Market by Source (Synthetic Caffeine, Natural Caffeine), and Application (Food and Beverages, Pharmaceuticals, Cosmetics and Personal Care, Others): Global Opportunity Analysis and Industry Forecast, 2023-2032". According to the report, the "caffeine powder market" was valued at $949.4 million in 2022, and is estimated to reach $1,612.1 million by 2032, growing at a CAGR of 5.5% from 2023 to 2032.

Key Points: 
  • Moreover, caffeine powder offers consumers the flexibility to customize their caffeine intake according to their preferences and needs.
  • In addition, the globalization of the caffeine powder market has led to increased accessibility and availability of products across regions and channels.
  • Furthermore, Europe is home to several prominent pharmaceutical and food industries that utilize caffeine powder in various formulations, further bolstering market growth.
  • With its robust market infrastructure, consumer demand, and regulatory framework, Europe is expected to maintain its leadership position in the global caffeine powder market.

Revive Drip’s Expert IV Nurses Bring Alternative Wellness Solutions to the Greater Puget Sound Area

Retrieved on: 
Monday, March 25, 2024
RN, Headache, Puget Sound, Nutrient, Pound, GIG, COVID-19, Patient, Trauma, Migraine, Suite, Dehydration, Nurse practitioner, Injection, Safety, Intravenous therapy, Collection, ARNP, Nursing

GIG HARBOR, WA, March 25, 2024 (GLOBE NEWSWIRE) -- Revive Drip, a leading mobile intravenous therapy (IV) company providing customized hydration and immune-boosting therapy throughout the Puget Sound, announced today the opening of the company’s brick-and-mortar clinic in Gig Harbor, Washington. The company’s expansion marks an exciting milestone for Revive Drip, delivering expert relief through progressive IV hydration for customers seeking alternative medical solutions.

Key Points: 
  • The company’s expansion marks an exciting milestone for Revive Drip, delivering expert relief through progressive IV hydration for customers seeking alternative medical solutions.
  • Since 2021, Revive Drip has been providing convenient and effective solutions tailored to their client’s specific wellness needs within the comfort of their client’s homes.
  • We provide expert nursing assessment skills combined with hydration and immune support for temporary relief,” explained Laura Ude, RN and Chief Operating Officer of Revive Drip.
  • Our services particularly benefit clients with autoimmune diseases, chronic headaches, and those seeking alternative solutions to the traditional medical system.

AEON Biopharma Announces Clinical Update and Productive End-of-Phase 2 Meeting with FDA on ABP-450 (prabotulinumtoxinA) for the Preventive Treatment of Migraine

Retrieved on: 
Tuesday, March 19, 2024
AEON, MMD, Patent, Caregiver, Headache, Migraine, Patient, Injection, Safety, AB toxin, Phase II, FDA, Food, MHD, Pharmaceutical industry

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, today announced a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) following the Phase 2 data in episodic migraine previously released in October 2023, that supports advancing ABP-450 (prabotulinumtoxinA) injection into the proposed pivotal Phase 3 program. As part of the updated development plan, the Company will now conduct an interim analysis of the ongoing Phase 2 study of ABP-450 for the preventive treatment of chronic migraine and anticipates releasing the data in the second quarter of 2024.

Key Points: 
  • Patients have at least a one-year history of migraine (with or without aura) according to the ICHD-3 (2018) definition and diagnostic criteria.
  • All patients will receive two treatment cycles 12 weeks apart utilizing the Company’s patented treatment paradigm (U.S. Patent No.
  • 11,826,405) involving fewer injections than the current botulinum toxin treatment option for migraine.
  • The interim analysis will include approximately 100 chronic migraine patients in each of the three arms that have completed the two 12-week treatment cycles.

AEON Biopharma Announces $15 Million Financing Transaction and Termination of Forward Purchase Agreements

Retrieved on: 
Tuesday, March 19, 2024
AEON, Private placement, Private, LTD, FPA, Sale, Migraine, Note, Alembic Pharmaceuticals, AB toxin, Food, FDA, Pharmaceutical industry

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE AMEX: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, today announced it has entered definitive agreements relating to a private placement (the "Private Placement") of $15 million (the “Investment Amount”) aggregate principal amount of senior secured convertible notes (the "Notes") with Daewoong Pharmaceutical Co., LTD. Proceeds from the Private Placement will be paid in a first installment of $5 million and a second installment of $10 million, in each case subject to the closing conditions set forth in the agreements. The Company expects the first installment to close before the end of March 2024 and the second to close in April 2024. Proceeds from the Private Placement will be used to support the late-stage clinical development of ABP-450 and for general working capital purposes. Upon funding of the second installment of the Investment Amount, the Company will appoint one designee of Daewoong to the AEON Board of Directors, subject to a customary due diligence process by AEON. The Daewoong designee must be a member of Daewoong’s senior management team.

Key Points: 
  • Proceeds from the Private Placement will be paid in a first installment of $5 million and a second installment of $10 million, in each case subject to the closing conditions set forth in the agreements.
  • The Company expects the first installment to close before the end of March 2024 and the second to close in April 2024.
  • Proceeds from the Private Placement will be used to support the late-stage clinical development of ABP-450 and for general working capital purposes.
  • Concurrent with the execution of the agreements for the Private Placement, the Company terminated its forward purchase agreements (each an “FPA” and the counterparties thereto, together, the “FPA Providers”).

Scilex Holding Company Provides Responses to Product Composition Questions Related to its ELYXYB® Patent in Canada for a New Drug Submission Under Review by Health Canada for the Approval of ELYXYB® for Acute Treatment of Migraine With or Without Aura in

Retrieved on: 
Monday, March 18, 2024
Neurology, Headache, NDS, Patient, Contraindication, Nonsteroidal anti-inflammatory drug, Chronic pain, Migraine, Health Canada, Chemical patent, PALO, OPML, Patent, Therapy, FDA

ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3

Key Points: 
  • ELYXYB® (celecoxib oral solution) is in the same class of agents, is fast acting, and has the potential to have the lowest gastrointestinal (GI) side effects of all NSAIDs.3
    The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and information requests by Health Canada.
  • ELYXYB®’s product profile mapped with a high degree of certainty to these stated unmet needs.
  • For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com .
  • For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com .