Topiramate

Ligand Pharmaceuticals Announces New Topiramate Injection Data Presented at 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference

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星期一, 四月 8, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Epilepsy, Plasma, LGND, Conference, UMN, Seizure, Status epilepticus, Patient, Topiramate, Orphan, Pharming, Concomitant, Pharmacokinetics, University, Faculty, Safety, Poster, Food, Pharmaceutical industry

The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.

Key Points: 
  • The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.
  • The authors presented modeling and simulations of IV topiramate dosing based on previous studies conducted by UMN faculty in healthy research participants and patients.
  • Ligand licensed the rights to the IV formulation of topiramate from UMN and entered into a global license agreement with CURx Pharmaceuticals to further develop and commercialize the product.
  • “The availability of an injectable topiramate formulation will make it possible to ensure continuity of therapy.

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

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星期二, 二月 27, 2024
Central nervous system, Topiramate, Investigational New Drug, PD, Total, New Drug Application, FDA, Food, Growth, PDUFA, Safety, GAAP, CNS, Depreciation, IQVIA, Patient, AISRS, Attention deficit hyperactivity disorder, DSM-IV codes, ADHD, Phase, MDD, Prescription, MADRS, Pharmaceutical industry

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points: 
  • Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
  • Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
  • Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
  • ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Supernus Wins Infringement and Validity Case on Trokendi XR® against Torrent

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星期一, 二月 5, 2024
Patent, The Orange Book, New Drug Application, Intellectual property, Central nervous system, FDA, Orange Book, Torrent, District court, Food, CNS, Torrent Pharmaceuticals, IP, Topiramate

ROCKVILLE, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos.

Key Points: 
  • ROCKVILLE, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos.
  • 8,992,989; 9,549,940; and 9,622,983 by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking permission to market a generic version of Trokendi XR® before the expiration of Supernus’ patents.
  • “We are very pleased with the District Court’s ruling that Torrent infringed our Trokendi XR® patents and the reaffirmation of the validity of those patents,” stated Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
  • The Orange Book lists a total of ten patents as covering Trokendi XR.

Hims & Hers Launches Holistic Weight Loss Program to Break the Endless Cycle of Weight Gain and Loss

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星期一, 十二月 4, 2023
Health, Telemedicine, Virtual Medicine, Fitness & Nutrition, General Health, Vitamins, Supplements, Pharmaceutical, Topiramate, Metformin, Hims & Hers Health, Sleep, Obesity, Depression, Research, NYSE, FACP, Naltrexone, Major trauma, Medication, Psychology, Gambling, Overweight, Patient, Multimedia, FAAP, Movement, FOMA, Motivation, Weight gain, Digital, Weight loss, MD, CDC, SVP, Heart Health Park, Vitamin B12, Birth control, Nursing, Dietary supplement, Behavior, Hers, Bupropion

View the full release here: https://www.businesswire.com/news/home/20231204073836/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231204073836/en/
    Weight Loss by Hims & Hers (Graphic: Business Wire)
    The science-backed Weight Loss by Hims & Hers program is developed with the expert insight of Dr. Primack and a team of clinical experts in obesity medicine, psychology and nutrition.
  • The program offers a well-rounded and more affordable approach to reducing weight by addressing the underlying factors that affect people’s weight – Nutrition, Behavior, Movement and Medical Treatment.
  • Weight Loss by Hims & Hers aims to address these issues by taking on the physical and psychological factors that contribute to weight gain and loss.
  • For more information on Hims & Hers’ weight loss program, please visit https://www.forhers.com/weight-loss and https://www.hims.com/c/wm/introduction .

Supernus Announces Third Quarter 2023 Financial Results

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星期三, 十一月 8, 2023
Adjustment, Topiramate, FDA, MADRS, New Drug Application, IND, PD, PDUFA, MDD, DSM-IV codes, Investigational New Drug, Research and development, GAAP, CNS, R, Phase, Prescription, Parkinson's disease, Depreciation, APOKYN, NDA, Safety, Psych, Patient, IQVIA, ADHD, Central nervous system, Attention deficit hyperactivity disorder predominantly inattentive, Video game, Medical device, Pharmaceutical industry, Cryptocurrency, Viloxazine

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022

Key Points: 
  • Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022
    Qelbree® net product sales of $37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023
    GOCOVRI® net product sales of $32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023
    Operating earnings (GAAP) of $8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of ($1.5) million in the third quarter of 2022
    Adjusted operating earnings (non-GAAP) of $37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022
    SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024
    ROCKVILLE, Md., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the third quarter of 2023, and associated Company developments.
  • “Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus.
  • Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
  • A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
    The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates.

Supernus Announces Second Quarter 2023 Financial Results

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星期二, 八月 8, 2023
Central nervous system, IQVIA, New Drug Application, Topiramate, ADHD, Prescription, GAAP, MADRS, CNS, Patient, Growth, Phase, Total, Safety, Arms industry, Clothing, Beauty salon, Pharmaceutical industry, Tutoring, Viloxazine

“In addition, despite the seasonally weak summer season in the ADHD market, Qelbree's net product sales grew by 20% in the second quarter of 2023 compared to the first quarter of 2023 showing the resiliency of the brand and its growth potential.

Key Points: 
  • “In addition, despite the seasonally weak summer season in the ADHD market, Qelbree's net product sales grew by 20% in the second quarter of 2023 compared to the first quarter of 2023 showing the resiliency of the brand and its growth potential.
  • We remain well positioned to drive strong revenue growth in 2024 and beyond.”
    Total IQVIA prescriptions were 146,344 in the second quarter of 2023, an increase of 133% compared to the same period last year and 9% compared to the first quarter of 2023.
  • Increase in prescription size and improvement in gross to net resulting in 10% increase in average net price per prescription to $212 in the second quarter of 2023 compared to the first quarter.
  • Qelbree continues to expand its base of prescribers, with approximately 21,291 prescribers in the second quarter of 2023, up from 19,197 prescribers in the first quarter of 2023.

Supernus Announces First Quarter 2023 Financial Results

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星期二, 五月 9, 2023
Autumn, Central nervous system, Symantec Endpoint Protection, IQVIA, New Drug Application, Topiramate, Prescription, GAAP, Pharmacy, MADRS, CNS, Patient, Growth, Phase, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Video game, Pharmaceutical industry, Nursing, Viloxazine

First quarter 2023 total revenues of $153.8 million, compared to $152.5 million in first quarter 2022

Key Points: 
  • First quarter 2023 total revenues of $153.8 million, compared to $152.5 million in first quarter 2022
    Qelbree® net product sales of $25.8 million, compared to $8.3 million in first quarter 2022
    GOCOVRI® net product sales of $26.0 million, compared to $22.6 million in first quarter 2022
    Excluding net product sales of Trokendi XR® in both periods, total net product sales increased 25%
    First quarter 2023 GAAP operating earnings of $5.2 million, compared to $2.0 million in first quarter 2022
    First quarter 2023 non-GAAP operating earnings of $30.5 million, compared to $28.0 million in first quarter 2022
    ROCKVILLE, Md., May 09, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the first quarter of 2023, and associated Company developments.
  • “We are pleased with the strong revenue and earnings performance despite the entry of generic Trokendi XR in the first quarter of 2023,” said Jack Khattar, President and CEO of Supernus.
  • Qelbree continues to expand its base of prescribers, with approximately 19,197 prescribers in the first quarter of 2023, up from 16,822 prescribers from the fourth quarter of 2022.
  • Excluding net product sales of Trokendi XR, first quarter 2023 total net product sales increased 25% compared to the same quarter last year.

At Fifteen Months Post-Launch, AbbVie's Qulipta Outperforms Pfizer's Nurtec ODT on Perceived Overall Efficacy in the Preventive Migraine Space, According to Spherix Global Insights

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星期四, 三月 16, 2023
Fremanezumab, NASA RealWorld-InWorld Engineering Design Challenge, Anticonvulsant, Migraine, Lundbeck, Teva, Eli Lilly and Company, Galcanezumab, Attention, Launch, Neurology, Parity, Topiramate, Tonix Pharmaceuticals, AbbVie, Physician, Safety, RealTime, Pharmaceutical industry, Erenumab, Atogepant, Pfizer

EXTON, Pa., March 16, 2023 /PRNewswire/ -- Spherix Global Insights recently released data from their Launch Dynamix™: Qulipta for Migraine Prevention (US) deep dive study tracking the launch of AbbVie's Qulipta for the preventive treatment of episodic migraines. At fifteen months post-launch, analysis reveals that AbbVie's brand has made significant strides over the course of their entry on prescriber perceptions, including increasingly favorable rating for Qulipta awareness, familiarity, use, satisfaction, likelihood to recommend, and the brand's risk/benefit and cost/benefit ratios.

Key Points: 
  • Use of Qulipta as a preventive migraine treatment still trails Nurtec ODT, but future projections have the brands' use on par.
  • Furthermore, the past several months have revealed quite a surge for Qulipta preference in a head-to-head comparison with Nurtec ODT among surveyed neurologists and migraine specialists (n=74).
  • Specifically, Qulipta is viewed as performing better than Nurtec ODT when it comes to overall efficacy and safety, and most notably, favorable dosing schedule.
  • As one migraine treater noted,
    "Qulipta is a good choice and the patient was more comfortable with Qulipta than the Nurtec dosing.

Supernus Announces Fourth Quarter and Full Year 2022 Financial Results

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星期二, 二月 28, 2023
Safety, Topiramate, Central nervous system, Acquisition, FDA, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, CNS, Growth, Attention deficit hyperactivity disorder predominantly inattentive, Prescription, Pharmacy, MADRS, Symantec Endpoint Protection, Phase, Food, Video game, Pharmaceutical industry, IQVIA, Adamas, Viloxazine

ROCKVILLE, Md., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2022 and associated Company developments.

Key Points: 
  • ROCKVILLE, Md., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2022 and associated Company developments.
  • The average wholesale acquisition cost per Qelbree prescription continued to increase in the fourth quarter of 2022, driven by increases in the average daily dose and prescription size.
  • Qelbree continues to expand its base of prescribers, with approximately 16,822 prescribers in the fourth quarter of 2022, up from 14,265 prescribers from the third quarter of 2022.
  • The following table provides information regarding net product sales during the three months and full year ended December 31, 2022 and 2021 (dollars in millions):

Alcohol Use Disorder Market to Witness Positive Growth at a CAGR of 8.8% by 2032 | DelveInsight

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星期三, 九月 28, 2022
Memantine, New, Social stigma, GHB, Perspiration, Compliance, ASP, Topiramate, Lists of diseases, Patient, Disulfiram, United Kingdom, Benzodiazepine, Astellas Pharma, National Institute, AUD, Psychiatric and mental health nursing, Prevalence, GABAB, Knowledge, Biomarker, Growth, Acamprosate, Alcoholism, Attention, Otsuka Pharmaceutical, Diagnostic and Statistical Manual of Mental Disorders, Drinking, ALKS, Health care, SMO, Gabapentin, Seizure, Corcept Therapeutics, Diagnosis, Hope, Population, Baclofen, Sodium oxybate, DSM, CORT, DSM-IV, LAS, VIVITROL, Mood Swings, National Institute on Alcohol Abuse and Alcoholism, Aripiprazole, Therapy, ALKS 3831, US FDA, DSM-V, Varenicline, Novo Nordisk, Pharmaceutical industry, Lithium, Alkermes, Ondansetron

LAS VEGAS, Sept. 28, 2022 /PRNewswire/ --DelveInsight's Alcohol Use Disorder Market Insights report includes a comprehensive understanding of current treatment practices, alcohol use disorder emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU5 (the United Kingdom, Italy, Spain, France, and Germany), Japan].

Key Points: 
  • Leading alcohol use disordercompanies such as Alkermes, Lundbeck, Otsuka Pharmaceuticals, Adial Pharmaceuticals, MediciNova, Corcept Therapeutics, Astellas Pharma, Bioprojet, and others are developing novel alcohol use disorder drugs that can be available in the alcohol use disorder market in the upcoming years.
  • DelveInsight estimates that there were approximately 25 million 12-month diagnosed prevalent cases of alcohol use disorder in the 7MM in 2021.
  • TOPAMAX (topiramate) is even recommended for alcohol use disorder treatment by the National Institute on Alcohol Abuse and Alcoholism.
  • Moreover, because of the change in alcohol use disorder diagnostic criteria from DSM-IV to DSM-V, country-specific epidemiologic data on diagnosis, severity, and treatment are scarce and thus limiting the alcohol use disorder market growth.