Supernus Pharmaceuticals, Inc. (SUPN), a biopharmaceutical company, announced on Monday that the U.S. Food and Drug Administration or FDA has approved an updated label for Qelbree or viloxazine extended-release capsules to include new pharmacodynamic data and lactation information.
Qelbree or viloxazine extended-release capsules is a prescription medicine used to treat ADHD in adults and children 6 years and older.
The updated label now provides insights into the pharmacodynamic profile of Qelbree, highlighting its partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter.
These additions emphasize the multimodal pharmacodynamics of Qelbree in the treatment of attention-deficit/hyperactivity disorder or ADHD.
In addition to the pharmacodynamic update, the new label includes information on Qelbree's transfer into breastmilk for breastfeeding women with ADHD.
The data suggests that the transfer is low, providing valuable information for healthcare providers treating breastfeeding mothers with ADHD.
Qelbree is now the first ADHD treatment to meet the FDA's post-marketing requirement for lactation studies, following the 2019 guidance on Clinical Lactation Studies.
Supernus believes that this update will help clinicians make informed decisions when prescribing Qelbree to patients, particularly those who are breastfeeding.
This updated labeling represents an important milestone for Supernus, reinforcing its commitment to advancing ADHD treatment options.
Currently, SUPN is trading at $39.60 up by 2.72%.
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