Pitolisant cataplexy. Medical search. Frequent questions

Harmony Biosciences has reaffirmed its confidence in the strength of WAKIX® (Pitolisant) patents, after receiving a positive ruling from the U.S. Patent and Trademark Office (USPTO) rejecting the request for reexamination. (pwsausa.org)
WAKIX® is used to treat excessive daytime sleepiness (EDS) or cataplexy in adults with Narcolepsy. (pwsausa.org)
We are pleased that the U.S. Patent and Trademark Office (USPTO) rejected a challenge to the validity of claims within the patent covering the active ingredient in WAKIX® (pitolisant), in line with our expectations. (pwsausa.org)
Pitolisant is available under the following different brand names: Wakix. (rxlist.com)
WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or sudden onset of weak or paralyzed muscles (cataplexy) in adults with narcolepsy. (canadadrugstore.com)
Wakix is distributed as 5mg and 20mg pitolisant hydrochloride tablets in Canada. (canadadrugstore.com)
In the USA Wakix tablets contain 4.45mg and 17.8mg of pitolisant. (canadadrugstore.com)
One stated that pitolisant-now better known as the prescription drug WAKIX-was approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. (sleepreviewmag.com)
But Harmony "believed in the data" from its clinical trials, which also showed improvements in cataplexy, says Harmony's chief medical officer Jeffrey Dayno, MD, and it wanted that indication in the label so narcolepsy patients for whom cataplexy is a significant symptom would have WAKIX as a therapeutic option. (sleepreviewmag.com)
The data showed about a 50% reduction in cataplexy in the WAKIX treatment group compared to placebo. (sleepreviewmag.com)
With this expanded label, WAKIX is the first and only treatment approved by the FDA for both EDS and cataplexy that is not scheduled as a controlled substance," Dayno says. (sleepreviewmag.com)
Especially in patients in whom cataplexy is a significant symptom and causes a real impact on daily functioning, physicians can now consider WAKIX as an important treatment option," Dayno says. (sleepreviewmag.com)
In response to a question about whether sodium content is a concern for WAKIX, Dayno advised that WAKIX's active ingredient is pitolisant hydrochloride, which is "not a sodium salt, so sodium content is not an issue with WAKIX. (sleepreviewmag.com)
How have branded agents such as pitolisant (Harmony Biosciences' Wakix), solriamfetol (Jazz Pharmaceuticals' Sunosi), and sodium oxybate (Jazz Pharmaceuticals' Xyrem) been integrated into the treatment algorithm, and what is their source of business? (clarivate.com)

The classic symptoms of the disorder, often referred to as the "tetrad of narcolepsy", are cataplexy, sleep paralysis, hypnagogic hallucinations, and excessive daytime sleepiness. (wikipedia.org)
Narcolepsy is characterized by the classic tetrad of excessive daytime sleepiness (EDS), cataplexy, hypnagogic hallucinations, and sleep paralysis. (medscape.com)
Pitolisant is used to treat excessive daytime sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) and to treat cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) in adults with narcolepsy. (medlineplus.gov)
Pitolisant may decrease your sleepiness, but it will not cure your sleep disorder. (medlineplus.gov)
Narcolepsy is characterized by chronic excessive daytime sleepiness, often with sudden loss of muscle tone (cataplexy). (msdmanuals.com)
In type 1 narcolepsy, people experience episodes of extreme cataplexy and sleepiness during the day because of having low levels of a protein known as hypocretin. (epainassist.com)
Narcolepsy is a sleep disorder that causes excessive daytime sleepiness, hallucinations, cataplexy, and sleep paralysis. (neurologysleepcentre.com)
Drugs such as Modafinil or armodafinil are prescribed for excessive daytime sleepiness, and drugs such as Xyrem for cataplexy. (neurologysleepcentre.com)
One should see a doctor when he/she is experiencing excessive daytime sleepiness, hallucinations, sleep attacks, or cataplexy. (neurologysleepcentre.com)
Newer CNS stimulants used for the treatment of residual daytime sleepiness and narcolepsy, such as pitolisant and solriamfetol, augment other monoamines and are associated with fewer adverse effects. (medlink.com)
Pitolisant is a prescription medication used for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy . (rxlist.com)
Orexin-deficiency is responsible for the main NT1 symptoms: sleepiness, cataplexy, disrupted nocturnal sleep, sleep-related hallucinations, and sleep paralysis. (bvsalud.org)
The time frame of at least three months of evolution of sleepiness to diagnose NT1 was removed in the ICSD-3-TR, when clear-cut cataplexy or orexin-deficiency are established. (bvsalud.org)
A low-sodium oxybate formulation was approved in July 2020 in the United States to treat cataplexy and excessive daytime sleepiness in patients 7 years old and older with narcolepsy. (bvsalud.org)
Now, the other patient who presents with excessive daytime sleepiness and cataplexy, where the cataplexy is quite frequent, would probably be most appropriately treated with sodium oxybate-and have 1 drug that addresses multiple facets of the disease by being taken at night, with a second dose 2 to 4 hours later. (neurologylive.com)
The advantages here are both improvement of daytime sleepiness and very effective improvement of cataplexy. (neurologylive.com)
I think that with the new agents-pitolisant, solriamfetol—having the ability now to provide treatments for those who still have daytime sleepiness with the traditional stimulants and the wake-promoting agents—and knowing that 10% to 60% of those patients still experience significant daytime sleepiness that is paralyzing them—providing add-on therapy is probably going to be advocated for. (neurologylive.com)
Pullen argued Prader-Willi syndrome symptoms are similar to what is seen in narcolepsy with cataplexy, a rare condition involving daytime sleepiness and sleep apnea. (futureofpersonalhealth.com)
In a clinical vignette in the March-April 2019 issue of the Journal of Pediatric Pharmacology and Therapeutics , Pullen and her co-authors reported that pediatric patients with Prader-Willi who used pitolisant had decreased daytime sleepiness and improved cognition. (futureofpersonalhealth.com)
The FDA says that Harmony Biosciences' drug-previously approved for excessive daytime sleepiness in narcolepsy-works for cataplexy too. (sleepreviewmag.com)
Now it can be assessed as a treatment option in terms of either excessive daytime sleepiness and/or cataplexy. (sleepreviewmag.com)
The INTUNE study is being conducted by Harmony Biosciences to evaluate the safety and efficacy of pitolisant, an investigational medication for treating excessive daytime sleepiness (EDS) in people with idiopathic hypersomnia age 18 years or older. (hypersomniafoundation.org)
In recognition that cataplexy can be difficult to diagnose in children, researchers at Jazz Pharmaceuticals and elsewhere have developed the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD). (chionfoundation.org)
A number of therapies from a range of drug classes are available to address the symptoms of narcolepsy, which include excessive daytime sleepiness and cataplexy. (clarivate.com)
The drug was approved by the EMA for "narcolepsy with or without cataplexy" in 2016 and for "excessive daytime sleepiness associated with obstructive sleep apnea syndrome" in 2021. (catalyspacific.com)
In the United States, the drug was approved by the FDA for "excessive daytime sleepiness associated with narcolepsy" in 2019, and "cataplexy associated with narcolepsy" in 2020. (catalyspacific.com)

New drugs like Pitolisant and Solriamfetol have been developed and approved for treatment against Narcolepsy. (neurologysleepcentre.com)

Startup Harmony Biosciences was close behind with pitolisant, already approved in Europe. (emoryhealthsciblog.com)
In August 2019, Harmony Biosciences Holdings Inc received two very different letters from the US Food and Drug Administration (FDA) about pitolisant, for which the company had submitted a new drug application for the treatment of narcolepsy. (sleepreviewmag.com)

Pitolisant may be used with modafinil or sodium oxybate. (bioprojet.uk)
These include Modafinil (Provigil), pitolisant, and sodium oxybate. (autostimes.com)

An episodic loss of muscle function, known as cataplexy, ranging from slight weakness such as limpness at the neck or knees, sagging facial muscles, weakness at the knees often referred to as "knee buckling", or inability to speak clearly, to a complete body collapse. (wikipedia.org)

The ESS-CHAD can be used in combination with a cataplexy diary to diagnose children with narcolepsy and cataplexy and the two are currently being used in a Phase III, placebo-controlled clinical trial of sodium oxybate in children and adolescents with narcolepsy. (chionfoundation.org)

Medications such as sodium oxybate ( Xyrem ) and venlafaxine (Effexor) can help prevent cataplexy. (healthline.com)
Sodium oxybate (Xyrem, generic) for cataplexy as well as for EDS. (adam.com)
Several newer wake-promoting agents and psychostimulants have also been developed, including sodium oxybate, which has a role in the treatment of cataplexy and as an adjunctive wake-promoting agent, and pitolisant, a selective histamine H3 receptor inverse agonist that is currently only available in Europe. (flutrackers.com)
Sodium oxybate (Xyrem) works well to control cataplexy. (nih.gov)
Jazz Pharmaceuticals), a combination of calcium, magnesium, potassium, and sodium oxybates, for the treatment of cataplexy or EDS in patients 7 years of age or older with narcolepsy. (neurologylive.com)

episodes of cataplexy, sleep paralysis, and hallucinations. (nih.gov)
It can also help with other symptoms of the disorder, such as cataplexy and hallucinations. (autostimes.com)

[ citation needed ] Cataplexy is generally considered to be unique to narcolepsy and is analogous to sleep paralysis in that the usually protective paralysis mechanism occurring during sleep is inappropriately activated. (sleepdisordersresource.com)

Type 2 does not have cataplexy as a symptom. (healthline.com)
Another common symptom of narcolepsy is cataplexy. (epainassist.com)
In this type, there is an extreme deficiency of hypocretin neurons and cataplexy is major symptom. (neurologysleepcentre.com)
In the absence of a lumbar puncture, the diagnosis is based on neurophysiological tests (nocturnal and diurnal) and the presence of the pathognomonic symptom cataplexy. (bvsalud.org)

About 70% of those affected also experience episodes of sudden loss of muscle strength, known as cataplexy. (wikipedia.org)
Type 1 features a sudden loss of muscle tone, known as cataplexy. (healthline.com)
This is known as cataplexy and can often be mistaken for being seizure activity, especially in children. (epainassist.com)

A nocturnal SOREMP is very specific but not sensitive enough, and the diagnosis of cataplexy is usually based on clinical interview. (bvsalud.org)
Moreover, the diagnosis of cataplexy may be the first clue that a patient has narcolepsy, a disorder that takes a median of nine years to be diagnosed, and for which there are now several treatment options. (chionfoundation.org)
The hope is that these tools, in combination with increased awareness in health care providers and patients, will facilitate the diagnosis of cataplexy in children, many of whom live with the label of being "lazy. (chionfoundation.org)

The researchers thus created a child-friendly definition of cataplexy that could be used in an electronic cataplexy daily diary designed for evening administration and self-completion by patients ≥ 9 years old. (chionfoundation.org)

Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. (bioprojet.uk)
Aculys Pharma, Inc. ("Aculys Pharma" Headquarters: Fujisawa City, Kanagawa Prefecture, Representative Director and CEO: Kazunari Tsunaba), a biopharmaceutical company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, announced that it has initiated a Phase 1 clinical trial of histamine H3 receptor antagonist / inverse agonist, pitolisant (development code: BF2.649) in Japan, and the first dose was administered successfully in January 2022. (catalyspacific.com)

People with type 1 narcolepsy experience cataplexy . (healthline.com)
You may experience cataplexy several times a day or only once a year. (healthline.com)
Moreover, unlike adults, children often experience cataplexy without a clear emotional trigger. (chionfoundation.org)

Each 4.5 mg tablet contains 5 mg pitolisant hydrochloride equivalent to 4.45 mg pitolisant. (bioprojet.uk)
Each 18 mg tablet contains 20 mg pitolisant hydrochloride equivalent to 17.8 mg pitolisant. (bioprojet.uk)
It is not uncommon for strengths to be listed differently such as 4.45mg of pitolisant and 5mg of pitolisant hydrochloride. (canadadrugstore.com)

People with this type of narcolepsy also have cataplexy or the sudden loss of muscle control or muscle tone. (epainassist.com)

you should know that pitolisant may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, injections, and intrauterine devices). (medlineplus.gov)

The medications that help to increase wakefulness include Modalert 200 Online , which contains armodafinil and pitolisant. (globonline.org)

Besides EDS, people with narcolepsy type 1 also have cataplexy, which is a sudden but temporary muscle weakness, sometimes brought on by laughter or other emotions. (adam.com)
Temporary and sudden muscle weakness without loss of consciousness (called cataplexy ), usually brought on by sudden or strong emotions. (adam.com)
Have received an NT1 diagnosis within the past 10 years or are experiencing NT1 symptoms (characterized by cataplexy, or the sudden loss of muscle control and muscle weakness due to strong emotions or actions, like anger or laughter, while remaining conscious). (hypersomniafoundation.org)

If it is found that the individual has hypocretin deficiency, experiences cataplexy, and has short REM sleep sleep latency, the person is diagnosed with Narcolepsy. (neurologysleepcentre.com)

pitolisant) is indicated in adults for the treatment of narcolepsy with or without cataplexy. (bioprojet.uk)
The first and only once-daily tablet that is FDA approved to treat EDS or cataplexy in adults with narcolepsy, that is not a controlled substance. (canadadrugstore.com)
While cataplexy is rare, experts agree that it is important for health care providers to recognize it and to know that its presentation differs in adults and children. (chionfoundation.org)

It so happens that in 2016, the European regulators approved pitolisant, a treatment for narcolepsy that targets the histamine 3 receptor. (futureofpersonalhealth.com)

In October 2020, the FDA approved pitolisant for the treatment of cataplexy in adult patients with narcolepsy. (sleepreviewmag.com)

Bear in mind that a lot of patients who have cataplexy may have a few episodes per week or may not require traditional therapy or a specific therapy for cataplexy itself and are able to manage it by avoiding situations—nothing that I would advocate the patients do, but they may not require a specific therapy directed at the cataplexy. (neurologylive.com)

Pitolisant is an antagonist / inverse agonist that selectively binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm. (catalyspacific.com)

Pitolisant efficacy may be impaired by tri- or tetra-cyclic antidepressants, antihistamines. (bioprojet.uk)
g, ethinyl estradiol) may be reduced when used with pitolisant, and reduction in efficacy may last for 21 days after discontinuation of therapy. (rxlist.com)

tell your doctor and pharmacist if you are allergic to pitolisant, any other medications, or any of the ingredients in pitolisant tablets. (medlineplus.gov)

The accompanying cataplexy may be mistaken for seizures. (wikipedia.org)
In some cases, cataplexy may resemble epileptic seizures. (wikipedia.org)

Pitolisant may affect the metabolism of CYP3A4, CYP2B6 and OCT1 substrates. (bioprojet.uk)

But the other stated the compound was not approved for the treatment of cataplexy in narcolepsy, citing statistical analysis deficiencies for this indication. (sleepreviewmag.com)

Seven months later, the boy presented to the hospital again, this time with cataplexy in the form of head dropping attacks. (chionfoundation.org)
Along with not being able to stay awake I also have cataplexy attacks. (sleep-disorders.net)

In late September, we closed our new agreement with Bioprojet, which will enable us to pursue new therapeutics based on pitolisant for the treatment of narcolepsy and potentially other indications mutually agreed to by the parties. (actusports.info)

Because of them, pitolisant is in clinical studies as a potential treatment for Prader-Willi syndrome. (futureofpersonalhealth.com)
CLICK HERE for research sites across the U.S. This is a Phase 2 clinical trial of SUVN-G3031, which is an investigational medicine (a histamine H3 receptor inverse agonist, similar to pitolisant , which is a tablet taken once daily). (hypersomniafoundation.org)
Cataplexy and Its Mimics: Clinical Recognition and Management. (chionfoundation.org)
Aculys Pharma has an exclusive licensing agreement for the clinical development and commercialization of pitolisant in Japan, and is developing the drug under development code BF2.649. (catalyspacific.com)

Strong emotions like fear or anger, or when you're laughing, may trigger cataplexy. (healthline.com)
Intense emotions like fear and excitement and laughing can also trigger cataplexy. (epainassist.com)

Tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs) may improve cataplexy. (wikipedia.org)

Enzyme inducers and CYP2D6 inhibitors may affect pitolisant metabolism. (bioprojet.uk)
Coadministration with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. (rxlist.com)

Talk to your doctor about types of birth control that will work for you during and after your treatment with pitolisant. (medlineplus.gov)
It's the first and only treatment that's FDA approved for both EDS and cataplexy that's not scheduled as a controlled substance and is one that offers a favorable benefit-risk profile. (sleepreviewmag.com)
Once diagnosed with narcolepsy with cataplexy, he received treatment and responded with a reduction of symptoms and normalization of body mass index. (chionfoundation.org)

Cataplectic facies is an unusual facial feature only recently described in children with narcolepsy with cataplexy, usually at disease onset. (medscape.com)
In the revised version of the International Classification of sleep Disorders, 3rd edition (ICSD-3-TR), a sleep onset rapid eye movement sleep (REM) period (SOREMP) (i.e. rapid occurrence of REM sleep) during the previous polysomnography may replace the diurnal multiple sleep latency test, when clear-cut cataplexy is present. (bvsalud.org)
Alternatively, at onset, cataplexy may present as persistent hypotonia and or/complex hyperkinetic movements. (chionfoundation.org)

Not only is cataplexy commonly seen in children with narcolepsy, but it can also be caused by other conditions such as Prader-Willi Syndrome, Niemann-Pick type C, and lesions in the hypothalamic or pontomedullary regions of the brain. (chionfoundation.org)

Narcolepsy paired with cataplexy is evidenced to be an autoimmune disorder. (wikipedia.org)

Type 1 narcolepsy (narcolepsy with cataplexy), the most common form of the condition, is caused by a deficiency in the neurotransmitter hypocretin (orexin). (adam.com)
On the horizon are experimental drugs designed to more precisely target the neuropeptide deficiency in people with classic narcolepsy type 1 (for narcolepsy with cataplexy: hypocretin/orexin agonists). (emoryhealthsciblog.com)

Patients with hepatic or renal impairment have a greater risk of QT prolongation due to higher pitolisant concentrations. (rxlist.com)

The frequency of cataplexy varies by person. (healthline.com)

Cataplexy causes a sudden but temporary loss of muscle tone and control. (epainassist.com)

Some people with narcolepsy have a sudden loss of muscle control, which is called cataplexy. (autostimes.com)

Anatomy1

Diseases7

Chemicals and Drugs9

Analytical, Diagnostic and Therapeutic Techniques and Equipment2

Psychiatry and Psychology12

Phenomena and Processes5

Humanities1

WAKIX14

Sleepiness26

Solriamfetol1

Harmony Biosciences2

Modafinil2

Episodic loss of muscle fun1

Children with narcolepsy and cataplexy1

Sodium5

Hallucinations2

Paralysis1

Symptom4

Known as cataplexy3

Diagnosis of cataplexy3

Definition of cataplexy1

Histamine H3-receptor antagon2

Experience cataplexy3

Hydrochloride3

Type of narcolepsy1

Effectiveness of hormonal contraceptives1

Armodafinil1

Muscle weakness3

Hypocretin deficiency1

Adults3

20161

20201

Episodes1

Antagonist1

Efficacy2

Tablets1

Seizures2

Substrates1

Indication1

Attacks2

Therapeutics1

Clinical4

Trigger2

SSRIs1

CYP2D62

Treatment3

Onset3

Commonly1

Disorder1

Orexin2

Hepatic1

Frequency1

Sudden but temporary1

Loss of muscle1