The only unregulated d'onset d'onset drug! Wakix has been approved by the FDA for new adaptations.

Newborn Harmony Biosciences is a biopharmaceutical company dedicated to developing innovative therapies for groups of patients with rare neurological disorders with severely unsoled medical needs.
recently, the company announced that the U.S. FDA has approved Wakix (pitolisant) for the treatment of sudden onset nardes in adult patients.
It's worth noting that Wakix is the first and only drug approved by the FDA that is not regulated by the U.S. Drug Enforcement Administration (DEA) for the treatment of daytime excessive drowsiness or suddenness associated with narcolepsy.
the United States, Wakix was first approved in 2019 to treat excessive daytime drowsiness in adult patients with narcolepsy.
Wakix is a pioneering drug whose active drug ingredient, pitolisant, is a selective histamine 3 (H₃) inhibitor/trans-excited agent that increases the synthesis and release of histamines, a neurotransmitter in the brain that promotes awakening.
medication, Wakix takes it once a morning by taking it or mouth-to-mouth.
onset narcolepsy is a chronic, rare neurological disorder in which all patients experience excessive daytime drowsiness, and two-thirds of them also experience sudden seizures, one of the most debilitating symptoms of narcolepsy, which can have a significant impact on the daily function of the patient.
is characterized by sudden, temporary loss of muscle tension, usually triggered by strong emotions such as excitement or laughter.
can be imperceptible (e.g. drooping of the eyelids) or severe (e.g. knee crank or fainting).
Because of the imperceptibleness of some patients' symptoms, the variability of the way they manifest them, and/or the lack of patient complaints or lack of awareness by the doctor of the symptoms as symptoms of the collapse, they are often unrecognized.
FDA's approval of Wakix for the treatment of sudden onset nardes in adult patients is based on the results of two randomized controlled trials (HARMONY CTP and HARMONY 1) in the Wakix clinical development project.
harmony met with the FDA in December 2019 to discuss the deficiencies mentioned in CRL, after the FDA issued a full response letter (CRL) in August 2019 regarding Wakix's application for a new drug for the treatment of inverted symptoms (NDA).
After that meeting, the FDA agreed to re-analyze the data analysis of the HARMONY 1 study submitted during the NDA review, which was later endorsed by the FDA and confirmed that the Wakix treatment group had a statistically significant reduction in the rate of sudden failure compared to the placebo group, which was supported by positive data from the HARMONY CTP trial.
, the FDA recommended resubmit the application, and Harmony finally won the FDA's nod today after submitting it in August 2020, approved Wakix's treatment for the disease.
As the first and only unconventional treatment for adult patients with seizure phobias, Wakix's approval of new adaptations will lead to a new, simplified treatment for patients and health care professionals that can address the two main symptoms of phobia with only one new mechanism of action drug.
source: Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® For The Treatment Of Cataplexy In Adult Patients With Narcolepsy.