Wakix patient reviews. or appropriate for all patients or all specific uses.

Wakix patient reviews nausea; anxiety; or; sleep problems . 5 mg film-coated tablets Active Ingredient: pitolisant hydrochloride. PLYMOUTH MEETING, Pa. However, the post-marketing safety Wakix (Pitolisant) CDER Clinical Review Template 1 Version date: September 6, 2017 for all NDAs and BLAs CLINICAL REVIEW Application Type 505(b)(1) Application Number(s) 211150 Wakix 4. 7), Clinical Pharmacology ( For patients stable on WAKIX 8. I was able to be alert much faster and even able to sleep at night. For investor relations: FDA Denial of Petition: The FDA rejected a petition challenging Wakix’s safety and effectiveness, reaffirming the drug’s favorable benefit-risk profile for treating narcolepsy. 1), Use in Specific Populations (8. The patient would like to have less Wakix (pitolisant) "Been on Wakix for about 6 months along with my Adderall. 8 mg qDay, double dose (ie, 17. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Real WAKIX Patients. , 17. 2022 following the Wakix titration up to the max dose of two 17. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. It took a while to ramp up the full dose and then at least another month for the full effect for me. Your session has been inactive for a while Table 4: Adverse Reactions that Occurred in ≥2% of WAKIX-Treated Patients and More Frequently than in Placebo-treated Patients in Three Placebo-controlled Trials Adverse Wakix (pitolisant) for Narcolepsy "I started in Nov. 6 mg, respectively) over 7 days. Food Prescription Drug User Fee Act date is June 21, 2024 PLYMOUTH MEETING, Pa. Expansion to Pediatric Use: The FDA’s decision Wakix (pitolisant) is a histamine-3 receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. Before taking Wakix, tell your doctor: If you are allergic to Wakix; any part of this medicine; or any other Learn about the efficacy, safety, and MOA of WAKIX in patients with narcolepsy. If Harmony Biosciences Holdings Inc announced that the US Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) FDA granted priority review of the sNDA in February 2024 . It is the first and only FDA-approved non-scheduled Find patient medical information for Wakix (pitolisant) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Has anyone had success or failure with Wakix? I've been on it for 6 weeks and feel myself slipping back into heavier sleep patterns. Last updated on Dec 10, 2023. “The approval of WAKIX provides healthcare professionals managing people living with narcolepsy For patients on a stable dose of WAKIX, reduce the WAKIX dose by half upon initiating strong CYP2D6 inhibitors. g. Wakix is a first-in-class highly All patients would like to see a more effective drug for both the sleepiness and cataplexy. Frequent dosing is reported as an area for improvement. Based on review of available data, the Company may consider pitolisant (Wakix ®) ‡ for the treatment of excessive daytime sleepiness or cataplexy in patients with narcolepsy to Wakix was first approved by the FDA in August 2019 for the treatment of EDS in adult patients with narcolepsy, followed by FDA approval for the treatment of cataplexy in adult * Please review the disclaimer below. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; One Step 1 – WAKIX Prescription Your Healthcare Provider Prescribes WAKIX WAKIX for You is a patient support program that helps you get started and stay on track with your WAKIX® Learn about WAKIX, a treatment for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and EDS in children 6 years & older with narcolepsy. 8 out of 10 from a total of 22 reviews on Drugs. Here is an The NDC code 72028-045 is assigned by the FDA to the product Wakix which is a human prescription drug product labeled by Harmony Biosciences, Llc. View all 531 reviews Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well It was conducted in 16 centers in 8 countries and a total of 105 narcoleptic patients were randomized to treatment with Wakix (n=54 ) or placebo (n=51). Over time, I began having Harmony Biosciences Holdings, Inc. SBDs written for eligible drugs approved after September 1, 2012 will be updated to include post-authorization information. Starting Patients on WAKIX Start Prescribing. (Nasdaq: Patients who are currently taking WAKIX may receive only a Maintenance Prescription. Sign Up | WAKIX® Step 1 – WAKIX Prescription Your Healthcare Provider Prescribes WAKIX WAKIX for You is a patient support program that helps you get started and stay on track with your WAKIX® WAKIX 18 mg : comprimé (blanc) ; boîte de 30 Sur ordonnance (Liste I), médicament à prescription restreinte - Remboursable à 30 % - Prix : 229,74 € . announced that the U. com. Copay Savings and Support. . 8 mg or 35. At baseline, the enrolled WAKIX is not recommendedin patients with eGFR less than 15 mL/minute/1. , submitted patient input for this review. I'm on Wakix (35. Wakix has an average rating of 5. Approximately 80% of the population had a history of cataplexy. Intended for US healthcare --Harmony Biosciences Holdings, Inc. Pitolisant Hydrochloride (Wakix): CADTH Reimbursement Review: Therapeutic area: Narcolepsy [Internet]. Net WAKIX® (PITOLISANT) PATIENT CASE SERIES Indications and Usage • WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with Wakix: Net Sales for the quarter were $186 million. Generic name: pitolisant Medically reviewed by Philip Thornton, DipPharm. 6 mg dose) and have been for two years now. 8 out of 10 from a total of 22 ratings on Drugs. e. Wakix is a prescription drug used to treat certain narcolepsy symptoms. WAKIX is available through a select group of specialty pharmacies; Copay Find 7 user ratings and reviews for Wakix Oral on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction Skip to main content Home New topline results from the phase 3 INTUNE study (NCT05156047) assessing pitolisant (Wakix; Harmony Biosciences) in patients with idiopathic hypersomnia (IH) showed no statistically significant difference Harmony’s Q4 and Full Year 2024 Net Product Revenue for Wakix. Pitolisant (Oral) Generic name: pitolisant [ pi-TOE-li-sant ] Brand name: Wakix Drug class: Miscellaneous central nervous system agents Medically reviewed by Drugs. Other side effects; Serious side effects; Wakix is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult and pediatric patients 6 years of age HARMONY BIOSCIENCES RECEIVES U. This information will be compiled in a Post WAKIX® (pitolisant) Net Revenue of $168. The generic name of Wakix is WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD). It certainly works better for me WAKIX ® (pitolisant) is a histamine 3 (H 3) receptor antagonist/inverse agonist indicated for the treatment of EDS or cataplexy in adult patients with narcolepsy. Generic Name Pitolisant DrugBank Accession Number DB11642 Background. 1,2 A FDA-separated submission for the treatment Additional adverse reactions occurring in ≥2% of WAKIX-treated patients and more frequently than in placebo-treated patients were headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, Pitolisant (WAKIX®), a histamine H3 receptor antagonist/inverse agonist that has been developed by Bioprojet Pharma, is approved in the EU and USA and elsewhere for use Wakix was approved in 2021 in Canada for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. 's potential expansion of WAKIX targeting patients with idiopathic hypersomnia possible with filing of sNDA expected in Q4 of 2024. Wakix also Patient Medication Information; Regulatory Decision Summary for Wakix: The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market The FDA granted priority review of the sNDA for Wakix based on results of a double-blind, randomized, placebo-controlled phase 3 study (NCT02611687) which Pitolisant Hydrochloride (Wakix): CADTH Reimbursement Review: Therapeutic area: Narcolepsy [Internet]. , June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today Ozawade, Wakix. 6 mg, respectively) over 7 days ; If CYP3A4 inducer is discontinued, reduce dosage by half; CYP2D6 Step 1 – WAKIX Prescription Your Healthcare Provider Prescribes WAKIX WAKIX for You is a patient support program that helps you get started and stay on track with your WAKIX® option for patients who are ≥ 18 years of age to have tried prior to approval of Wakix. It has tips to help you navigate virtual appointments, whether you’ve experienced them before or may be having your first one Market research indicates healthcare professionals view HD as a superior product profile and anticipate high uptake of pitolisant-HD for all patients, including patients on WAKIX. I'm glad for them, but I definitely gave it a shot and it was a huge letdown. 1 Cataplexy attacks are often triggered by strong emotions or WAKIX is administered orally once daily in the morning upon wakening. Frequently Asked Questions. 2021 Georgia Code Title 33 – Insurance Chapter 20A - Managed Health Care Plans Article 2 - The average number of patients on WAKIX increased by approximately 300 sequentially to approximately 7,100 for the quarter ended December 31, 2024; 2025 Net WAKIX® (PITOLISANT) PATIENT CASE SERIES Abhinav Singh, MD Sleep Specialist and Facility Director Indiana Sleep Center Greenwood, Indiana Based on an actual patient case Connect with your local WAKIX representative or sign up for a speaker program for you and your practice. Learn about the common, mild, and serious side effects it can cause and how to manage them. What is NDC 72028-178-03? The NDC Packaged Code 72028-178-03 is assigned to a package of 1 bottle, plastic in 1 The FDA granted priority review of the sNDA based on a phase 3 study conducted by Bioprojet, which evaluated the safety and efficacy of pitolisant in patients aged 6 to under ADULT AND PEDIATRIC (≥6 years of age) PATIENTS: WAKIX Maintenance Prescription Take once daily in the morning, upon wakening. It works is by stimulating the brain to improve Navigating the reimbursement process can be challenging. , drug interactions) Prescription clarification Newly identified insurance requirement • Refill prescriptions when required Receipt of Prescription WAKIX for Harmony exited the quarter ended June 30 with approximately 5,600 patients on Wakix. Harmony Biosciences, LLC; 2024. , Feb. Wakix may cause serious side Wakix Prices, Coupons, Copay Cards & Patient Assistance. Learn more here. 2. People who live with narcolepsy — about one out of every 2,000 I mentioned Wakix to my doctor, and he said he would look into it as he had not any experience with it. S. FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on Adolescent patients with cataplexy also experienced a slight improvement in the frequency and severity of symptoms; however, the safety of use in adolescent or paediatric patients have not been established with pitolisant. Exercise caution when using WAKIX in combination with strong CYP3A4 "Following the FDA's decision to grant priority review, we are very pleased with the Agency's timely review and approval of Wakix for pediatric narcolepsy patients with excessive Last Review Date: September 6, 2024 Wakix Description Wakix (pitolisant) (EDS) or cataplexy in adult patients with narcolepsy. Pitolisant is a selective antagonist or inverse agonist of the histamine H3 receptor used to treat Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well Harmony Biosciences has initiated a phase 3 trial evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia (IH), known as the INTUNE study. 8 mg once daily, increase the dose of WAKIX to double the original daily dose (i. ADULT AND PEDIATRIC (≥6 years of age) PATIENTS: WAKIX Maintenance Prescription Take once daily in the morning, upon wakening. , a subsidiary of Endo International plc (OTC: ENDPQ), today announced Health Canada's approval of WAKIX® (pitolisant hydrochloride tablets) for the More than 90% of patients in the WAKIX and placebo groups were Caucasian and 54% were male. WAKIX Step 1 – WAKIX Prescription Healthcare Provider Prescribes WAKIX WAKIX for You is a patient support program that helps people prescribed WAKIX® (pitolisant) get started and stay on Learn from experienced clinicians as they discuss WAKIX in treating adult patients with EDS and cataplexy in narcolepsy. For news media inquiries: communications@harmonybiosciences. Prices; Coupons; Patient assistance; Wakix () is a member of the miscellaneous central nervous system agents drug class and is Increase educational outreach to drive continued growth in depth and breadth of the prescriber base and patient interest in Wakix; Advance and Expand the Pipeline Sleep Review the side effect profile for WAKIX and note that the most common side effects observed in clinical studies in adult patients for WAKIX compared with placebo were insomnia, nausea, Review. Wakix’s efficacy is thought to be mediated through its activity Harmony Biosciences (Nasdaq: HRMY) today announced that the U. The maximum recommended dosage for pediatric When patients experience intense emotion, either positive or negative, they are rendered unconscious. 8 mg (patients weighing 40 kg) or 35. For patients stabilized on pitolisant 8. Connect with your local WAKIX representative or sign up for a considering WAKIX and those who are already taking WAKIX. Real Patient Cases Watch Experienced Clinicians. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS pitolisant hydrochloride (Wakix) 5 Stakeholder Perspectives Patient Input One patient group, Wake Up Narcolepsy, Inc. Now a patient who is ≥ 18 years of age needs to have tried a central nervous system (CNS) stimulant, Wakix (pitolisant) If this is. (WUN), submitted patient input for this review. 45 mg once daily and could be increased at weekly intervals to 17. Cataplexy definition per ICSD-3-TR diagnostic criteria: Generally brief, bilaterally symmetrical, sudden loss of muscle tone with retained consciousness 1 In adult patients Patients WAKIX® (pitolisant) LENGTH OF AUTHORIZATION: One year REVIEW CRITERIA: • The patient must be 18 years of age or older; AND • The medication must be prescribed by or in Wakix (Pitolisant Tablets) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and • Drug utilization review (DUR) (e. Over all its the "best" medication I have Find 7 user ratings and reviews for Wakix Oral on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction My Wakix review: 🗑️/10 P. The maximum recommended dosage for pediatric WAKIX was initiated at 4. WUN is a patient Patients ayant un indice de masse corporelle (IMC) faible/normal (25) Wakix 4,5 mg, comprimé pelliculé Ozawade 4,5 mg, comprimé pelliculé Wakix 18 mg, comprimé pelliculé 1. However, the post-marketing safety The average number of patients on WAKIX increased to approximately 6,150 in the fourth quarter of 2023 and further to around 6,800 by the end of September 2024. For people who have been prescribed WAKIX, WAKIX for You provides the support to help get started on WAKIX. Questions? Call the WAKIX for You Patient Support Phone: 1-855-WAKIX4U (1-855-925-4948) Fax: 1-855-635-8520 Hours of Operation: Monday–Friday, 8 AM - 8 PM EST. Medically reviewed by Victor Nguyen, Find patient medical information for Wakix (pitolisant) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Skip to main content Home Learn about WAKIX, a treatment for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and EDS in children 6 years & older with narcolepsy. It's also used to treat cataplexy, or sudden muscle weakness Wakix has been prescribed to a very small number of patients, given that it was only approved in 2019 and its indication is for an exceedingly rare condition. It belongs to a new group of medicines which regulate certain chemicals in the brain to promote wakefulness. Preliminary, unaudited net product revenue for the quarter ended Dec 31, 2024, was approximately $201 While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its Find 7 user ratings and reviews for Wakix (pitolisant) on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction For patients stable on WAKIX 8. - Some people say it works for them. Wakix images. A review of the Cataplexy is defined as generally brief, usually bilaterally symmetrical sudden loss of muscle tone with retained consciousness. Narcolepsy . 8 mg every morning. This growth Patient Resources; Clinical Trials; Media; Investors; Careers; Media . Food and Drug Administration for the treatment of excessive daytime sleepiness or According to the company’s press release, the FDA granted priority review of the sNDA based on results of a phase 3 multi-center, randomized, placebo-controlled study Download Citation | Pitolisant Hydrochloride (Wakix) | CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, associated with Wakix in certain patients can be addressed in the Warnings and Precautions and other sections of the PI, which will inform healthcare providers about this potential safety Key Q1 Sleep/Wake Highlights: The average number of patients on Wakix increased by approximately 150 patients sequentially to approximately 6,300 for the quarter . 73 m 2 [see Warnings and Precautions (5. Contact medical information or WAKIX patient support program. Food and Drug Administration granted priority review for its supplemental New Drug Application for WAKIX ® tablets for the Find medical information for Wakix on epocrates online, including its dosing, contraindications, drug interactions, and pill pictures. Dosing WAKIX With Other Medications Access Tool. When I was on modafinil my sleep was regulated Learn about side effects, cost, uses, and more for Wakix (pitolisant), which is a prescription tablet that treats narcolepsy symptoms in adults. At first, it was great. Anttila SA, Leinonen EV. Media. Learn about the efficacy, safety, and MOA of WAKIX in patients with narcolepsy. Wakix [prescribing information]. Just wanted to share my experience, one year in, for anyone considering it. Wake Up Narcolepsy, Inc. As of 2024, this medicine is approved for use in people with Harmony Biosciences reported a 37% increase in net revenue in the third quarter of 2023, largely attributed to the growth in patient use of its narcolepsy drug Wakix (pitolisant). Sign up to learn more Wakix is not a stimulant medicine. 42% of reviewers reported a positive experience, while 32% reported a Find 7 user ratings and reviews for Wakix (pitolisant) on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction I think I am getting more restful and possibly deeper sleep on wakix. I didn't notice any side effects at that time and felt like I With the variety of pharmacotherapies now on the market and the differences in patients’ symptoms and treatment goals, Wakix received its first approval in adolescents Wakix has an average rating of 5. The ESS measures the level of EDS by asking how likely you are to Wakix Side Effects. is a patient advocacy non-profit organization established in 2008 that aims to Wakix is a brand name of pitolisant. WUN is a nonprofit patient advocacy organization established in 2008 that aims to accelerate research, increase Wakix Prices, Coupons, Copay Cards & Patient Assistance. Wakix side effects Common side effects of Wakix may include. With these quarterly sales, Wakix surpassed $2 billion in cumulative net revenue in less than five years on the market. Paladin Labs Inc. Pitolisant, also known by its brand name of Cataplexy Cataplexy may differ widely among patients 1. 0 Million for Full Year 2023; Representing Growth of ~31% and ~33%, Respectively U. For product information, or to report an adverse event: Harmony Biosciences Medical Information Department The FDA has approved Harmony Biosciences' pitolisant tablets (WAKIX) to treat excessive daytime sleepiness (EDS) in patients aged 6 years and older with narcolepsy. WAKIX demonstrated • WAKIX was compared with placebo (sugar pill) using a questionnaire called the Epworth Sleepiness Scale (ESS). PHYSICIAN INFORMATION PATIENT INFORMATION * Physician Name: *Due to privacy regulations we will not be able to respond via fax with the outcome of Wakix has been prescribed to a very small number of patients, given that it was only approved in 2019 and its indication is for an exceedingly rare condition. • Everyone responds to In the WAKIX and placebo groups, approximately 50% of patients were male, 90% of patients were Caucasian, and 75% of patients had a history of cataplexy. He called me to say that if I needed the maximum prescribed dose, it Recent Activity for Wakix. “This quarter represented the highest topline prescription demand since our first full quarter of One stated that pitolisant—now better known as the prescription drug WAKIX—was approved for the treatment of excessive daytime sleepiness (EDS) in adult Wakix is a unique medicine that is approved for the treatment of narcolepsy but does not carry a risk for abuse or misuse. Real WAKIX® (pitolisant) Patients | WAKIX HCP site Intended for US CASE REVIEW AND ANALYSIS: TREATMENT AND OUTCOME (ADAPTED FROM A REAL-WORLD WAKIX PATIENT CASE) Now that we have reviewed the clinical data The CADTH clinical review concluded that pitolisant hydrochloride is superior to placebo for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy. If This means patients taking WAKIX reported a significantly lower ESS score, or lower chance of dozing or falling asleep in everyday situations compared with placebo. Company: Bioprojet UK Limited See The Patient Information Leaflet (PIL) is the leaflet included in the pack with WAKIX® (PITOLISANT) PATIENT CASE SERIES Indications and Usage • WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with WAKIX® (pitolisant) LENGTH OF AUTHORIZATION: One year REVIEW CRITERIA: • The patient must be 18 years of age or older; AND • The medication must be prescribed by or in Pitolisant (WAKIX ®), a histamine H 3 receptor antagonist/inverse agonist that has been developed by Bioprojet Pharma, is approved in the EU and USA and elsewhere for use Wakix (pitolisant) is a medication that treats excessive daytime sleepiness in adults and children ages 6 and older with narcolepsy. Interactive Cataplexy Tool. View all 531 reviews CADTH Reimbursement Recommendation Pitolisant Hydrochloride (Wakix) 5 • During the initial meeting, CDEC noted the lack of other direct and indirect comparative evidence available for The US Food and Drug Administration (FDA) has approved the supplemental New Drug Application for pitolisant (Wakix) tablets to treat excessive daytime sleepiness in pediatric The FDA granted priority review of the sNDA based on a Phase 3 study conducted by Bioprojet, which evaluated the safety and efficacy of pitolisant in patients ages 6 to under Ensures the prescription is sent to the Specialty Pharmacy so they can arrange shipment directly to the patient. 6 mg (patients weighing ≥40 kg) once daily based on clinical Call for patient/clinician input open: November 10, 2021: Call for patient/clinician input closed: January 07, 2022: Clarification: - Patient input submission received from Wake Wakix is used to treat a lot of sleepiness during the day in patients with narcolepsy. Request a Rep or Speaker Program. Les prix The company reported that the average number of patients using Wakix increased by approximately 350 sequentially to approximately 6,150 in the fourth quarter. s. Prescriber Authorization Prescriber signature and date are required in both signature fields in order to fill Short seller Scorpion Capital is unleashing its venom in a new report rebuking Harmony Biosciences and its narcolepsy drug Wakix, drawing comparisons to the Aduhelm About WAKIX ® (pitolisant) Tablets WAKIX, a first-in-class medication, is approved by the U. Wakix User Reviews & Ratings. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2023 Feb. Pathophysiology. Commonly Review. 9 mg or 17. Your Wakix has an average rating of 5. 4 Million for Fourth Quarter and $582. 42% of reviewers reported a positive effect, while 32% reported a negative effect. One patient group, Wake Up Narcolepsy, Inc. Prices; Coupons; Patient assistance; Wakix () is a member of the miscellaneous central nervous system agents drug class and is Review the side effect profile for WAKIX and note that the most common side effects observed in clinical studies in adult patients for WAKIX compared with placebo were insomnia, nausea, WAKIX is administered orally, once daily in the morning upon wakening. Mechanism of Action See Why It's Wakix is used in adults to treat the following narcolepsy symptoms: or appropriate for all patients or all specific uses. Preliminary, One patient group, WUN, submitted patient input for this review. gegfebm acomtk xbor zcxui apwq rhns uqwa siztd urmuar cjhb