CIII

WAYLIVRA (volanesorsen): An Antisense Oligonucleotide Inhibitor of Apolipoprotein CIII (apoCIII) mRNA - Market Size, Forecasts, and Emerging Insights, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 27, 2024

Further, it also consists of future market assessments inclusive of the WAYLIVRA market forecast analysis for lipodystrophy in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in lipodystrophy.

Key Points: 
  • Further, it also consists of future market assessments inclusive of the WAYLIVRA market forecast analysis for lipodystrophy in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in lipodystrophy.
  • WAYLIVRA (volanesorsen), an antisense oligonucleotide inhibitor of apolipoprotein CIII (apoCIII) mRNA, is being developed by Ionis Pharmaceuticals through its subsidiary company, Akcea Therapeutics to treat familial partial lipodystrophy (FPL).
  • Volanesorsen is an antisense oligonucleotide that binds to apoC-III mRNA, leading to its degradation and preventing the translation of apoC-III protein.
  • What are the other emerging products available and how are these giving competition to WAYLIVRA for lipodystrophy?

Global Narcolepsy Drugs Market Research Report 2024: Pipeline Analysis, Key Company Profiles and Recent Developments 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 30, 2024

The "Global Narcolepsy Drugs Market (By Therapeutic Type, Disease Type, End User, Regional Analysis), Pipeline Analysis, Key Company Profiles and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Narcolepsy Drugs Market (By Therapeutic Type, Disease Type, End User, Regional Analysis), Pipeline Analysis, Key Company Profiles and Recent Developments - Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global narcolepsy drugs market has witnessed significant growth in recent years owing to the rising prevalence of narcolepsy and increased awareness about the condition.
  • Latin America and Middle East & Africa are competing closely to grab the maximum share of the global narcolepsy drugs market.
  • Global Narcolepsy Drugs Market - Key Company Profiles, Recent Developments, Financial Insights

Avadel Pharmaceuticals Announces Data Supporting Clinical Profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) at World Sleep 2023

Retrieved on: 
Friday, October 20, 2023

DUBLIN, Ireland, Oct. 20, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, today announced new and encore data supporting the clinical profile for LUMRYZ™ (sodium oxybate) for extended-release oral suspension (CIII) and patient preference for a once-nightly oxybate in 15 poster presentations and two oral presentations, at World Sleep 2023, being held from October 20-25, 2023 in Rio de Janeiro, Brazil. LUMRYZ (previously known as FT218), is a U.S. Food and Drug Administration (FDA) approved extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Key Points: 
  • “We are excited to be at this year’s World Sleep meeting with another robust display of data that supports both the established clinical benefit of LUMRYZ,” said Jennifer Gudeman, PharmD, Senior Vice President, Medical and Clinical Affairs of Avadel.
  • “Quality sleep is a foundational pillar of health for people with narcolepsy, yet ~65% of patients with narcolepsy experience poor, fragmented sleep in addition to their daytime symptoms.
  • LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS.
  • Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting.

BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder

Retrieved on: 
Tuesday, September 5, 2023

PLYMOUTH MEETING, Pa., Sept. 5, 2023 /PRNewswire/ -- Braeburn announces that BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, is now available in the U.S. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Key Points: 
  • BRIXADI is the first and only injectable buprenorphine for the treatment of moderate to severe OUD that offers weekly and monthly doses.
  • "Opioid use disorder remains a public health crisis with over 82,000 people dying from an opioid overdose last year," said Mike Derkacz, President and CEO of Braeburn.
  • "We've remained committed to making another option available for healthcare providers to treat their patients with OUD, and the availability of BRIXADI is a significant milestone for Braeburn."
  • BRIXADI is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology, allowing for a low volume pre-filled syringe with a thin needle.

Catalyst Pharmaceuticals Announces Multiple Abstracts on FYCOMPA® (Perampanel) from Eisai Co, Ltd., to be Presented at the 35th International Epilepsy Congress

Retrieved on: 
Monday, August 14, 2023

These are presentations by Eisai Co., Ltd. ("Eisai"), which holds the rights to FYCOMPA in countries and regions outside the U.S.

Key Points: 
  • These are presentations by Eisai Co., Ltd. ("Eisai"), which holds the rights to FYCOMPA in countries and regions outside the U.S.
  • Some abstracts will also be considered for publication in Epilepsia following the IEC.
  • The accepted abstracts and presentations detail the results from clinical and real-world studies, further documenting the uses of perampanel in both focal and generalized epilepsy across a diverse range of patients.
  • “These findings, which are being presented at IEC, further validate and add to the growing body of evidence supporting the benefits of perampanel in the treatment of seizure disorders,” said Gary Ingenito, MD, PhD, Chief Medical and Regulatory Officer of Catalyst.

Altruix Approved to Dispense Brixadi® for Moderate to Severe Opioid Use Disorder

Retrieved on: 
Thursday, August 17, 2023

ANNAPOLIS, Md., Aug. 17, 2023 /PRNewswire/ -- Altruix, a leading provider of behavioral health pharmacy solutions, announced today that it has been selected as a limited distribution partner by Braeburn Inc. for BRIXADI (buprenorphine) extended-release subcutaneous injection (CIII).

Key Points: 
  • Local Altruix pharmacies will fill prescriptions for extended-release buprenorphine injection for patients with moderate to severe opioid use disorder.
  • BRIXADI is an extended-release injection approved by the FDA to treat moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine- containing product.
  • "BRIXADI is another unique option to help the physicians we partner with to treat the growing threat of opioid use disorder," says Eric Elliott, CEO, Altruix.
  • BRIXADI provides a noteworthy advancement in providing another option to treat opioid use disorder."

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Orexo's patent win for ZUBSOLV® appealed

Retrieved on: 
Monday, July 24, 2023

The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.

Key Points: 
  • The litigation was initiated in September 2020 because of Sun's submission of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval of generic versions of ZUBSOLV®.
  • Sun has now appealed the district court's decision to the US Court of Appeals for the Federal Circuit.
  • We remain very confident in the strength of the patent portfolio and that the Court of Appeals will come to the same conclusion."
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."

Orexo wins patent litigation for ZUBSOLV® in the US

Retrieved on: 
Saturday, July 1, 2023

The district court found that Orexo´s patents are valid and infringed by Sun.

Key Points: 
  • The district court found that Orexo´s patents are valid and infringed by Sun.
  • As a result of the decision, Sun is prohibited from launching its generic ZUBSOLV® tablets until September 2032, and Orexo's patent protection remain unchanged.
  • ZUBSOLV® is currently protected by ten patents listed in the Orange Book with expiration dates ranging from December 2027 to September 2032.
  • Now we look forward to focusing on continuing to grow our business and bringing innovative treatment solutions to patients."