Harmony Biosciences To Present WAKIX® (pitolisant) Efficacy and Safety Data at Upcoming 2021 American Psychiatric Association Annual Meeting
"Both excessive daytime sleepiness and cataplexy can have a significant impact on a person's daily functioning, which may greatly affect their social, emotional and psychological well-being," said Harmony's Chief Medical Officer,
The data to be presented by Harmony will be available from
- Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Adult Patients With Narcolepsy: A Review of Clinical Trials (Poster 4463). L Krahn, C Davis, J-C Schwartz, J Dayno.
- Analysis of results from HARMONY 1 and HARMONY 1bis, two pivotal randomized, placebo-controlled, 8-week trials that assessed the efficacy and safety of pitolisant for the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Efficacy of Pitolisant, a Selective Histamine 3 (H3)-Receptor Antagonist/Inverse Agonist, in the Treatment of Cataplexy in Patients With Narcolepsy (Poster 4460). M Thorpy, J-C Schwartz, C Caussé, J Dayno.
- A review of results from HARMONY 1, HARMONY 1bis, HARMONY CTP and HARMONY 3 Phase 3 clinical trials, which assessed safety and efficacy of pitolisant for the treatment of cataplexy in adults with narcolepsy.
- Time Course of Improvement in Excessive Daytime Sleepiness and Cataplexy During Treatment with Pitolisant in Patients with Narcolepsy (Poster 4469). C Davis, J Dayno, B Vaughn, Y Dauvilliers, J-C Schwartz.
- Analysis evaluating the time-to-response to treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, placebo-controlled trials in adults with narcolepsy.
About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the
Important Safety Information
WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation and in patients with severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.
WAKIX 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. Avoid use of WAKIX in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.
The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is not recommended in patients with end-stage renal disease (ESRD).
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.
Please see the Full Prescribing Information for WAKIX for more information.
Narcolepsy is a rare, chronic, debilitating neurological disorder of sleep-wake state instability that impacts approximately 165,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation, which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin, a neuropeptide in the brain that supports sleep-wake state stability. This disorder affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed.
About Harmony Biosciences
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of WAKIX, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with
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