Pitolisant

Harmony Biosciences To Present WAKIX® (pitolisant) Efficacy and Safety Data at Upcoming 2021 American Psychiatric Association Annual Meeting

Retrieved on: 
Dienstag, April 27, 2021
Branches of biology, Cardiac arrhythmia, Chloroarenes, Circulatory system, Cardiovascular system, Orphan drugs, Cardiac electrophysiology, QT interval, Long QT syndrome, Pitolisant

WAKIX has been commercially available in the U.S. since Q4 2019.

Key Points: 
  • WAKIX has been commercially available in the U.S. since Q4 2019.
  • It was granted orphan drug designation for the treatment of narcolepsy in 2010.
  • WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.\nWAKIX prolongs the QT interval.
  • Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval.

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

Retrieved on: 
Mittwoch, Oktober 14, 2020
Sleep disorders, Branches of biology, Psychoactive drugs, Neurological disorders, Narcolepsy, Pitolisant, Cataplexy, Excessive daytime sleepiness, Somnolence, Sleep, Idiopathic hypersomnia, Microsleep

WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

Key Points: 
  • WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.
  • FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX.
  • Up to two-thirds of all patients with narcolepsy have cataplexy, which can have a significant impact on a person's daily functioning.
  • WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting

Retrieved on: 
Montag, September 21, 2020
Sleep disorders, Health, Psychoactive drugs, Breakthrough therapy, Pharmacy, Narcolepsy, Orphan drugs, Cataplexy, Pitolisant

Axsome is very pleased with the FDA feedback from our recent Breakthrough Therapy meeting, which resulted in an expedited path to a potential NDA filing for AXS-12 in the treatment of cataplexy in narcolepsy, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.

Key Points: 
  • Axsome is very pleased with the FDA feedback from our recent Breakthrough Therapy meeting, which resulted in an expedited path to a potential NDA filing for AXS-12 in the treatment of cataplexy in narcolepsy, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.
  • In August 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-12 for the treatment of cataplexy in narcolepsy.
  • Axsome will host a conference call and webcast with slides today at 8:00 AM Eastern to discuss the expedited development plan for AXS-12 for the treatment of narcolepsy following a Breakthrough Therapy meeting with the FDA.
  • AXS-12 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and Orphan Drug Designation for the treatment of narcolepsy.

Harmony Biosciences To Present Clinical Data On WAKIX® (pitolisant) At Upcoming World Sleep 2019

Retrieved on: 
Montag, September 16, 2019
Clinical research, Health, Medical research, Psychoactive drugs, Design of experiments, Chloroarenes, Ethers, Pitolisant, Stimulants, Narcolepsy, Clinical trial, Placebo

PLYMOUTH MEETING, Pa., Sept. 16, 2019 /PRNewswire/ -- Harmony Biosciences, LLC (Harmony) announced today it will present clinical data on the efficacy and safety of WAKIX (pitolisant) at the World Sleep 2019 meeting in Vancouver, Canada from September 20-25, 2019.

Key Points: 
  • PLYMOUTH MEETING, Pa., Sept. 16, 2019 /PRNewswire/ -- Harmony Biosciences, LLC (Harmony) announced today it will present clinical data on the efficacy and safety of WAKIX (pitolisant) at the World Sleep 2019 meeting in Vancouver, Canada from September 20-25, 2019.
  • Results from a post hoc analysis evaluating the efficacy of pitolisant in patients with a high burden of narcolepsy symptoms.
  • Data were pooled from two randomized, placebo-controlled, seven- and eight-week studies of pitolisant in adults with narcolepsy.
  • Analysis of integrated safety data from four randomized, placebo-controlled, clinical studies of pitolisant in adult patients with narcolepsy.

Harmony Biosciences Announces FDA Approval Of WAKIX® (Pitolisant), A First-In-Class Medication For The Treatment Of Excessive Daytime Sleepiness In Adult Patients With Narcolepsy

Retrieved on: 
Donnerstag, August 15, 2019
Psychoactive drugs, Stimulants, Sleep disorders, Chemical compounds, Organic compounds, Chloroarenes, Ethers, Piperidines, Pitolisant, Narcolepsy, Excessive daytime sleepiness, Somnolence

PLYMOUTH MEETING, Pa., Aug. 15, 2019 /PRNewswire/ --Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

Key Points: 
  • PLYMOUTH MEETING, Pa., Aug. 15, 2019 /PRNewswire/ --Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
  • The efficacy of WAKIX for the treatment of EDS in adult patients with narcolepsy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies (HARMONY 1 and HARMONY 1bis).
  • WAKIX is a first-in-class medication approved for use in the U.S. for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.
  • WAKIX (pitolisant) is approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.

Harmony Biosciences To Present New Data On Pitolisant In Patients With Narcolepsy At SLEEP 2019 Meeting

Retrieved on: 
Dienstag, Juni 4, 2019
Psychoactive drugs, Stimulants, Health, Chloroarenes, Ethers, Piperidines, Pitolisant, RTT, Chemistry, Narcolepsy, Clinical trial, Microsleep

"These data are representative of the body of scientific evidence that has been generated for pitolisant, which characterizes its safety/tolerability and efficacy profile in adult patients with narcolepsy with or without cataplexy.

Key Points: 
  • "These data are representative of the body of scientific evidence that has been generated for pitolisant, which characterizes its safety/tolerability and efficacy profile in adult patients with narcolepsy with or without cataplexy.
  • Results are being presented from an interim data collection of the Pitolisant Expanded Access Clinical Evaluation (PEACE) Program, which provides adult patients in the U.S. living with narcolepsy access to treatment with pitolisant.
  • This presentation reports on an analysis of integrated safety data from four randomized, placebo-controlled, clinical studies of pitolisant in adult patients with narcolepsy.
  • Harmony is committed to advancing the understanding of narcolepsy and providing information and resources to individuals who live with, and healthcare professionals who treat patients with, this disorder.

Data On Abuse Potential Of Pitolisant Presented At 2018 European Sleep (ESRS) Congress

Retrieved on: 
Donnerstag, September 27, 2018
Chemistry, RTT, Pharmacology, Medicine, Stimulants, Piperidines, Chloroarenes, Attention deficit hyperactivity disorder, Narcolepsy, Therapeutic index, Medroxyprogesterone acetate, Pitolisant

PLYMOUTH MEETING, Pa., Sept. 27, 2018 /PRNewswire/ --Harmony Biosciences, LLC (Harmony) announced today that French pharmaceutical company Bioprojet SCR (Bioprojet) presented new human abuse potential (HAP) data on pitolisant at the 24th Congress of the European Sleep Research Society (ESRS) in Basel, Switzerland.

Key Points: 
  • PLYMOUTH MEETING, Pa., Sept. 27, 2018 /PRNewswire/ --Harmony Biosciences, LLC (Harmony) announced today that French pharmaceutical company Bioprojet SCR (Bioprojet) presented new human abuse potential (HAP) data on pitolisant at the 24th Congress of the European Sleep Research Society (ESRS) in Basel, Switzerland.
  • "There is a significant unmet need for non-scheduled options that healthcare professionals can prescribe to treat patients living with narcolepsy."
  • The HAP study of pitolisant evaluated the abuse potential of single doses of pitolisant compared to phentermine (Schedule IV stimulant) and placebo when administered to healthy, non-dependent, recreational stimulant users using a four period cross-over design.
  • Pitolisant was given at a therapeutic dose of 40 mg and at a supratherapeutic dose of 240 mg while phentermine was given at a dose of 60 mg.

Harmony Biosciences Presents 5-Year Data On Pitolisant At International Narcolepsy Symposium

Retrieved on: 
Dienstag, September 11, 2018
Chemistry, Pharmacodynamics, Neurochemistry, Piperidines, Ethers, Biochemistry, Chloroarenes, Pitolisant, Stimulants, Narcolepsy, Receptor antagonist, Agonist

PLYMOUTH MEETING, Pa., Sept. 11, 2018 /PRNewswire/ -- Harmony Biosciences, LLC (Harmony) presented new data on pitolisant at the 7th International Symposium on Narcolepsy in Beverly, MA.

Key Points: 
  • PLYMOUTH MEETING, Pa., Sept. 11, 2018 /PRNewswire/ -- Harmony Biosciences, LLC (Harmony) presented new data on pitolisant at the 7th International Symposium on Narcolepsy in Beverly, MA.
  • Long term data (up to 5-years) from the Harmony III open-label, naturalistic study were presented in a platform presentation.
  • These data assessed the safety, tolerability and durability of effect of pitolisant, the first potent and highly selective histamine 3 (H3)receptor antagonist/inverse agonist.
  • Harmony Biosciences received the 2017 Deal of the Year Award from Life Sciences PA. For more information on Harmony Biosciences, visit www.harmonybiosciences.com .

Bioprojet: Pitolisant Progresses Towards the U.S. Market

Retrieved on: 
Dienstag, Mai 22, 2018
Health, Chemistry, Food and Drug Administration, Breakthrough therapy, Fast track, Pitolisant, Medication

We remind you that Pitolisant is now marketed under the Tradename Wakix or in the process of commercialization in most European countries.

Key Points: 
  • We remind you that Pitolisant is now marketed under the Tradename Wakix or in the process of commercialization in most European countries.
  • Pitolisant is an investigational medication in the U.S. that is not currently approved by the FDA.
  • The receipt of Breakthrough Therapy and Fast Track designations for pitolisant allows Harmony to request a rolling submission from the FDA with the goal of obtaining approval to market this new medication in the U.S. in 2019.
  • Its activity is focused on the design, synthesis and development of novel classes of drugs for unmet medical needs, such as Pitolisant (Wakix).