Viloxazine

Knight Therapeutics Enters into Exclusive License Agreement with Supernus Pharmaceuticals for Qelbree® (viloxazine) in Canada

Retrieved on: 
Tuesday, December 19, 2023
Partnership, Food, GUD, Viloxazine, SNMA, CNS, TSX, Central nervous system, Patient, ADHD, Pharmaceutical industry

Qelbree® is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Key Points: 
  • Qelbree® is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a nonstimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
  • Financial terms of the agreement were not disclosed.
  • A third phase 4 clinical trial9 is studying the impact of Qelbree® on co-morbid mood symptoms prevalent in patients with ADHD.
  • "Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD."

Supernus Announces Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 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.

Jay Glazer Teams Up with Supernus Pharmaceuticals to Raise Awareness of ADHD and his Qelbree® Journey

Retrieved on: 
Monday, October 16, 2023
Diagnosis, Constipation, Mania, Xerostomia, ADHD, Vomiting, Personality, Bipolar disorder, Somnolence, Perseverance, Fatigue, Medicine, Vital signs, Heart rate, Nausea, Headache, FDA, Insomnia, Appetite, Television, Blood pressure, Depression, Patient, MAOI, Theophylline, Boxed warning, Solidarity, Irritability, Child, Attention deficit hyperactivity disorder predominantly inattentive, Dietary supplement, Nursing, Residential care, Birth control, Viloxazine

“I’m partnering with Supernus to help others overcome the stigmas associated with ADHD and help those diagnosed understand they are not alone,” says Glazer.

Key Points: 
  • “I’m partnering with Supernus to help others overcome the stigmas associated with ADHD and help those diagnosed understand they are not alone,” says Glazer.
  • Since I was diagnosed later in life as an adult, it has been difficult trying to find the right treatment.
  • “Supernus stands with the ADHD community year-round, and especially during ADHD Awareness Month, offering solidarity, support and understanding for those living with the condition,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
  • Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms

Retrieved on: 
Sunday, September 10, 2023
Blood pressure, Psych, MAOI, Fatigue, Research and development, Central nervous system, Depression, Senior, AE, Mania, State University of New York Upstate Medical University, Xerostomia, Aes, ADHD, Trae tha Truth, Constipation, Medicine, Appetite, CNS, OLE, AISRS, Vomiting, Administration, Insomnia, Vital signs, Patient, Child, Boxed warning, Psychiatry, Theophylline, Nausea, Somnolence, Behavioral medicine, Heart rate, Upper respiratory tract infection, FDA, Headache, Function (mathematics), Irritability, Bipolar disorder, Food, Safety, Dietary supplement, Birth control, Pharmaceutical industry, Copper, Residential care, Viloxazine

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.

Key Points: 
  • Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.
  • “These data demonstrate Qelbree’s ability to enhance efficacy when co-administered with stimulants, including significant improvement during evening hours when the effects of stimulants often wear off following their morning dose.
  • Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54).
  • Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9 (13.48).

Supernus Announces Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 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

Retrieved on: 
Tuesday, May 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.

Supernus Announces Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Tuesday, February 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):

Supernus to Present at the Piper Sandler 34th Annual Healthcare Conference

Retrieved on: 
Tuesday, November 22, 2022
Lotte New York Palace Hotel, Growth, Epilepsy, Government, Piper Sandler Companies, Prescription, Conference, ADHD, Patient, Central nervous system disease, Central nervous system, Torticollis, CNS, Webcast, Security (finance), Depression, Dyskinesia, Section 13, Risk, Migraine, Safety, Pharmaceutical industry, Adamantas, PD, Viloxazine

The conference will take place November 29 December 1, 2022 at the Lotte New York Palace in New York City.

Key Points: 
  • The conference will take place November 29 December 1, 2022 at the Lotte New York Palace in New York City.
  • Investors interested in arranging a meeting with company management should contact the Piper Sandler conference coordinator.
  • An archived replay of the webcast will be available for 60 days on the Company's website following the conference.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Supernus to Present at Two November Healthcare Conferences

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, Private Securities Litigation Reform Act, Adult, U.S. Securities and Exchange Commission, Depression, Central nervous system disease, Prescription, ADHD, Torticollis, Risk, Nasdaq, Epilepsy, Investor relations, Section 13, Government, Migraine, Safety, Securities Exchange Act of 1934, Dyskinesia, Company, Patient, Growth, CEO, Security (finance), Central nervous system, Lotte New York Palace Hotel, CNS, Pharmaceutical industry, Viloxazine, Adamantas, PD

A live webcast of the presentations can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com .

Key Points: 
  • A live webcast of the presentations can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com .
  • An archived replay of these webcasts will be available for 60 days on the Company's website after the respective conferences.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
  • These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations.

Supernus Provides Regulatory Update on SPN-830

Retrieved on: 
Monday, October 10, 2022
CRL, U.S. Securities and Exchange Commission, Migraine, Dyskinesia, Torticollis, Growth, Review, Endpoint security, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ADHD, Patient, Depression, Security (finance), Risk, Nasdaq, Private Securities Litigation Reform Act, Food, Prescription, Company, Epilepsy, Section 13, CEO, Adult, Securities Exchange Act of 1934, Safety, CNS, GLOBE, Government, Travel, FDA, COVID-19, Central nervous system, Central nervous system disease, OFF, Pharmaceutical industry, PD, Viloxazine

SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinsons disease (PD).

Key Points: 
  • SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinsons disease (PD).
  • Supernus will continue to work closely with the FDA to address all questions, and when possible, to provide clarity regarding the potential timing of a resubmission of the NDA.
  • Supernus Pharmaceuticalsis a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
  • The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.