Cataplexy

Idorsia Announces World Champion Skier, Philanthropist and Entrepreneur Lindsey Vonn as Patient Ambassador for QUVIVIQ™ (daridorexant), a Once Nightly Treatment for Insomnia

Retrieved on: 
Tuesday, July 19, 2022
Sleep apnea, Thought, Adult, Alertness, Mental health, Lung, Research, Facebook, United States Census Bureau, Sleep hygiene, Patient, Lists of diseases, Headache, Vitamin, Pain, Wakefulness, Academy of Family Physicians of India, Falling, Sleep, Depression, Cognitive behavioral therapy, Population, Tell, Full, Twitter, General manager, Hyperkinesia, Goal, Exercise, Lindsey, Sleep disorder, Cataplexy, Brain, CIV, Knee, PI, Muscle weakness, Medication, Sex, Multimedia, Tablet, Medicine, Instagram, Complex, Prevalence, Health, Conditional sentence, Hallucination, Partnership, Sleep paralysis, FDA, Somnolence, Diet, Suicide, Awareness, Pharmaceutical industry, Dietary supplement, Liquor, Residential care, Mail order, Risk management, Incorporation (business), Insomnia

RADNOR, Pa., July 19, 2022 /PRNewswire/ -- Idorsia Pharmaceuticals, U.S. Inc, today announced its partnership with Lindsey Vonn, world champion skier, philanthropist, entrepreneur and insomnia patient as an ambassador for QUVIVIQ (daridorexant) CIV.

Key Points: 
  • RADNOR, Pa., July 19, 2022 /PRNewswire/ -- Idorsia Pharmaceuticals, U.S. Inc, today announced its partnership with Lindsey Vonn, world champion skier, philanthropist, entrepreneur and insomnia patient as an ambassador for QUVIVIQ (daridorexant) CIV.
  • I talked with my doctor and was prescribed QUVIVIQ, a new prescription treatment for adults with insomnia," says Vonn.
  • Adults struggling with sleep should speak with their doctor to see if QUVIVIQ is the right treatment option for them.
  • Vonn's doctor prescribed her QUVIVIQ and after taking QUVIVIQ nightly, she started to notice a difference in her sleep.

Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ™ (sodium oxybate) extended-release oral suspension

Retrieved on: 
Tuesday, July 19, 2022
Research, SEC, Patent, District court, Lesbian flag, Patient, Security (finance), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, REMS, Nasdaq, Securities and Exchange Commission (Philippines), EDS, Safety, Knowledge, Orange Book, GLOBE, Securities Exchange Act of 1934, Food, Forward-looking statement, Narcolepsy, Avadel Pharmaceuticals, Sodium oxybate, Cataplexy, District, Securities Act of 1933, Motion, Company, NDA, Drug Quality and Security Act, Excessive daytime sleepiness, Annual report, Court, FDA, 1836 U.S. Patent Office fire, Somnolence, Douglas v. U.S. District Court ex rel Talk America, Population, Pharmaceutical industry, Online gambling, Risk management

DUBLIN, Ireland, July 19, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to LUMRYZ, also known as FT218. Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent No. 8,731,963 (the “REMS patent”) which is listed in FDA’s Orange Book. LUMRYZ is a once-at-bedtime investigational formulation of sodium oxybate for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

Key Points: 
  • Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S.
  • We have reached a critical milestone, as tentative approval confirms the safety profile and clinical efficacy of LUMRYZ for adults with narcolepsy, said Greg Divis, Chief Executive Officer at Avadel Pharmaceuticals.
  • Tentative approval is an important regulatory step forward and indicates LUMRYZ could potentially be granted final approval in 11 months or less.
  • We believe once-at-bedtime LUMRYZ offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy.

Avadel Pharmaceuticals Provides Corporate Update

Retrieved on: 
Wednesday, June 29, 2022
Mitigation, Sodium oxybate, Review, FDA, Annual report, Avadel Pharmaceuticals, Patient, Narcolepsy, REMS, Securities Act of 1933, Securities Exchange Act of 1934, Court, International, Workforce, GLOBE, Cataplexy, Population, EDS, Company, District court, U.S. Securities and Exchange Commission, Forward-looking statement, Orange Book, ID, Food, Douglas v. U.S. District Court ex rel Talk America, Certification, Risk Evaluation and Mitigation Strategies, Drug Quality and Security Act, Nasdaq, Somnolence, SEC, Lesbian flag, Paragraph, Patent, Webcast, Safety, Knowledge, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NDA, Security (finance), Education, Pharmaceutical industry, Risk management

DUBLIN, Ireland, June 29, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the steps it is taking to explore every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (“REMS”) with FDA and expects to receive tentative approval of FT218.

Key Points: 
  • In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy.
  • Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.
  • We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Axsome Therapeutics Hosts Sunosi® Investor Update Virtual Event Today with Key Opinion Leaders

Retrieved on: 
Tuesday, June 28, 2022
Complaint, FDA, Sleep paralysis, Migraine, Patient, Research, MDD, Therapy, Food and Drug Administration, Cataplexy, Man, PAP, CNS, Company, Hypnagogia, Disease, CPAP, Mortality, NDA, Solriamfetol, Woman, Risk, Food, Continuous positive airway pressure, Clinical trial, Narcolepsy, Somnolence, ASCEND, Sleep apnea, Lists of diseases, Physician, GEMINI, Obstructive sleep apnea, Pharmaceutical industry, COVID-19

You are encouraged to report negative side effects of prescription drugs to the FDA.

Key Points: 
  • You are encouraged to report negative side effects of prescription drugs to the FDA.
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for CNS conditions that have limited treatment options.
  • Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions.
  • At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.

Axsome Therapeutics to Host Sunosi® Investor Update Virtual Event

Retrieved on: 
Wednesday, June 22, 2022
Complaint, CNS, FDA, NDA, Food and Drug Administration, Mortality, Sleep apnea, GEMINI, Somnolence, Migraine, Company, CPAP, Man, Research, Disease, Lists of diseases, Sleep paralysis, Physician, Clinical trial, Continuous positive airway pressure, Obstructive sleep apnea, Narcolepsy, ASCEND, Cataplexy, Food, Patient, Hypnagogia, PAP, Therapy, Woman, Solriamfetol, Risk, MDD, Pharmaceutical industry, COVID-19

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for CNS conditions that have limited treatment options.

Key Points: 
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for CNS conditions that have limited treatment options.
  • Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions.
  • At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.
  • The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Avadel Pharmaceuticals and the American Academy of Sleep Medicine Foundation Announce an Exclusive Collaboration on the 2022 Young Investigators Research Forum

Retrieved on: 
Friday, June 3, 2022
EDS, Sleep Research Society, Cataplexy, Program, Research, Mental health, Lunch, The Westin Charlotte, American Academy, Partnership, Associated, Doctor of Pharmacy, Narcolepsy, Nasdaq, SOAR, AASM, Sodium oxybate, GLOBE, Patient, Avadel Pharmaceuticals, Sleep, MD, Westin Hotels & Resorts, ASSM, American Academy of Sleep Medicine, Pharmaceutical industry

DUBLIN, Ireland, June 03, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it entered into an exclusive collaboration with the American Academy of Sleep Medicine (AASM) Foundation, to support its 2022 Young Investigators Research Forum (YIRF), providing scholarships and research training to early career sleep medicine researchers.

Key Points: 
  • DUBLIN, Ireland, June 03, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it entered into an exclusive collaboration with the American Academy of Sleep Medicine (AASM) Foundation, to support its 2022 Young Investigators Research Forum (YIRF), providing scholarships and research training to early career sleep medicine researchers.
  • The Young Investigators Research Forum is a unique annual training program that was first launched in 2009, providing guidance, tactics, and strategies to better position early career investigators for a successful career in sleep research.
  • AASM Foundation President Anita V. Shelgikar, MD, MHPE added, We thank Avadel for their continued support of early career sleep researchers and their sponsorship of the 2022 Young Investigators Research Forum.
  • Avadels exclusive sponsorship of YIRF continues with the companys participation in the 2022 AASM Foundation, YIRF and Sleep Research Program for Advancing Careers (SOAR) Networking Lunch.

Avadel Pharmaceuticals to Present at the Jefferies Healthcare Conference

Retrieved on: 
Thursday, June 2, 2022
Sodium oxybate, GLOBE, Patient, Cataplexy, Conference, Narcolepsy, Nasdaq, Somnolence, Pharmaceutical industry

DUBLIN, Ireland, June 02, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer, and Tom McHugh, Chief Financial Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 9, at 4:00 p.m. E.T.

Key Points: 
  • DUBLIN, Ireland, June 02, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer, and Tom McHugh, Chief Financial Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 9, at 4:00 p.m. E.T.
  • A live webcast of the fireside chat, as well as an archived recording, will be available on Avadels Investor Relations website, investors.avadel.com , for 90 days following the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.
  • Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options.

Avadel to Present Clinical Data for FT218 at SLEEP 2022

Retrieved on: 
Thursday, May 19, 2022
American Academy, American Academy of Sleep Medicine, Narcolepsy, Excessive daytime sleepiness, Nasdaq, 2021 Essex County Council election, Patient, Associated, Sleep paralysis, Avadel Pharmaceuticals, Review, Sleep Research Society, DNS, Cataplexy, FDA, EDS, Sleep, Sodium oxybate, Hypnagogia, Safety, GLOBE, Pharmaceutical industry

DUBLIN, Ireland, May 19, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of clinical data for FT218 in nine posters at the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS), the joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society being held from June 4-8, 2022 in Charlotte, NC.

Key Points: 
  • DUBLIN, Ireland, May 19, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the presentation of clinical data for FT218 in nine posters at the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS), the joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society being held from June 4-8, 2022 in Charlotte, NC.
  • The presentations will highlight new interim data related to dosing and titration from the ongoing RESTORE open-label extension/switch study of FT218.
  • In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy.
  • Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study.

Avadel Pharmaceuticals to Present at the H.C. Wainwright Global Investment Conference

Retrieved on: 
Wednesday, May 18, 2022
Cataplexy, Patient, Sodium oxybate, Somnolence, Narcolepsy, Conference, Nasdaq, GLOBE, Pharmaceutical industry, Avadel Pharmaceuticals

DUBLIN, Ireland, May 18, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on Wednesday, May 25 at 8:30 a.m. E.T.

Key Points: 
  • DUBLIN, Ireland, May 18, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on Wednesday, May 25 at 8:30 a.m. E.T.
  • A live webcast of the fireside chat, as well as an archived recording, will be available on Avadels Investor Relations website, investors.avadel.com , for 90 days following the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.
  • Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options.

Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2022 Financial Results

Retrieved on: 
Monday, May 9, 2022
CNS Drugs (journal), REM, U.S. Securities and Exchange Commission, Sleep, Narcolepsy, Forward-looking statement, World, Nasdaq, EDS, GLOBE, Company, Medicine, NDA, Excessive daytime sleepiness, Securities Act of 1933, Securities Exchange Act of 1934, Food, Injury, Safety, AAN, Patient, Security (finance), Review, Webcast, FDA, International, Drug Quality and Security Act, Anxiety, Avadel Pharmaceuticals, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Knowledge, New Drug Application, Income, American Academy, Cataplexy, SEC, ID, Research, Sodium oxybate, Pharmaceutical industry, Fine chemical, Risk management, Video game

ET

Key Points: 
  • ET
    DUBLIN, Ireland, May 09, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update, and announced its financial results for the first quarter ended March 31, 2022.
  • R&D expenses were $7.0 million in the quarter ended March 31, 2022, compared to $3.9 million for the same period in 2021.
  • SG&A expenses were $21.6 million in the quarter ended March 31, 2022, compared to $11.0 million for the same period in 2021.
  • The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.