Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women
Supernus Pharmaceuticals (SUPN) announced FDA approval for an updated label of its ADHD treatment Qelbree. The update includes new pharmacodynamic data detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting the drug's multimodal pharmacodynamics.
The label update also includes new lactation data showing low transfer of Qelbree into breastmilk, making it the first ADHD treatment to meet post-marketing requirements following the 2019 FDA guidance on Clinical Lactation Studies. The study, involving 15 healthy lactating women, demonstrated that the relative infant dose was approximately 1% of the maternal daily dose.
Qelbree is approved for ADHD treatment in patients 6 years and older. The medication carries important safety information, including risks of increased suicidal thoughts and actions, blood pressure elevation, and heart rate changes.
Supernus Pharmaceuticals (SUPN) ha annunciato l'approvazione da parte della FDA per un'etichetta aggiornata del suo trattamento per l'ADHD Qelbree. L'aggiornamento include nuovi dati farmacodinamici che dettagliano l'attività parziale di agonismo del recettore serotoninergico 5-HT2C e l'inibizione del trasportatore della norepinefrina, evidenziando la farmacodinamica multimodale del farmaco.
L'aggiornamento dell'etichetta include anche nuovi dati sulla lattazione che mostrano un basso trasferimento di Qelbree nel latte materno, rendendolo il primo trattamento per l'ADHD a soddisfare i requisiti post-marketing dopo le linee guida della FDA del 2019 sugli Studi Clinici di Lattazione. Lo studio, che ha coinvolto 15 donne sane in allattamento, ha dimostrato che la dose relativa per il neonato era di circa l'1% della dose giornaliera materna.
Qelbree è approvato per il trattamento dell'ADHD in pazienti di 6 anni e oltre. Il farmaco presenta importanti informazioni di sicurezza, tra cui rischi di aumento di pensieri e azioni suicide, aumento della pressione sanguigna e cambiamenti nella frequenza cardiaca.
Supernus Pharmaceuticals (SUPN) anunció la aprobación de la FDA para una etiqueta actualizada de su tratamiento para el TDAH Qelbree. La actualización incluye nuevos datos farmacodinámicos que detallan la actividad de agonista parcial del receptor de serotonina 5-HT2C y la inhibición del transportador de norepinefrina, destacando la farmacodinámica multimodal del fármaco.
La actualización de la etiqueta también incluye nuevos datos sobre la lactancia que muestran una baja transferencia de Qelbree a la leche materna, lo que lo convierte en el primer tratamiento de TDAH en cumplir con los requisitos post-comercialización tras la guía de la FDA de 2019 sobre Estudios Clínicos de Lactancia. El estudio, que involucró a 15 mujeres lactantes sanas, demostró que la dosis relativa para el lactante era aproximadamente el 1% de la dosis diaria materna.
Qelbree está aprobado para el tratamiento del TDAH en pacientes de 6 años en adelante. El medicamento conlleva información importante sobre seguridad, incluidos los riesgos de aumento de pensamientos y acciones suicidas, elevación de la presión arterial y cambios en la frecuencia cardíaca.
Supernus 제약 (SUPN)은 ADHD 치료제 Qelbree의 업데이트된 라벨에 대한 FDA 승인을 발표했습니다. 업데이트에는 세로토닌 5-HT2C 부분 작용제 활성 및 노르에피네프린 수송체 억제에 대한 새로운 약리역학 데이터가 포함되어 있어 약물의 다중 모달 약리역학을 강조합니다.
라벨 업데이트에는 Qelbree의 모유 전이량이 낮다는 새로운 수유 데이터도 포함되어 있으며, 2019년 FDA의 임상 수유 연구 가이드라인을 따른 후 시판 후 요건을 충족하는 최초의 ADHD 치료제로 자리 잡았습니다. 15명의 건강한 수유 여성들을 포함한 연구에서는 상대 신생아 용량이 모체의 일일 용량의 약 1%라는 결과가 나타났습니다.
Qelbree는 6세 이상 환자의 ADHD 치료제로 승인되었습니다. 이 약물은 자살 사상 및 행동 증가, 혈압 상승 및 심박수 변화와 같은 중요한 안전 정보가 포함되어 있습니다.
Supernus Pharmaceuticals (SUPN) a annoncé l'approbation par la FDA d'une étiquette mise à jour pour son traitement du TDAH Qelbree. La mise à jour comprend de nouvelles données pharmacodynamiques détaillant l'activité d'agoniste partiel des récepteurs de sérotonine 5-HT2C et l'inhibition des transporteurs de norepinéphrine, soulignant la pharmacodynamique multimodale du médicament.
La mise à jour de l'étiquette comprend également de nouvelles données sur l'allaitement montrant un faible transfert de Qelbree dans le lait maternel, faisant de lui le premier traitement du TDAH à répondre aux exigences post-commercialisation suite aux directives de la FDA de 2019 sur les études cliniques concernant l'allaitement. L'étude, impliquant 15 femmes allaitantes en bonne santé, a démontré que la dose relative pour le nourrisson était d'environ 1 % de la dose quotidienne maternelle.
Qelbree est approuvé pour le traitement du TDAH chez les patients de 6 ans et plus. Le médicament comporte des informations de sécurité importantes, y compris des risques d'augmentation des pensées et des actions suicidaires, d'élévation de la pression artérielle et de variations de la fréquence cardiaque.
Supernus Pharmaceuticals (SUPN) hat die Genehmigung der FDA für ein aktualisiertes Etikett seines ADHS-Medikaments Qelbree angekündigt. Das Update enthält neue pharmakodynamische Daten, die die partielle Agonistenaktivität des Serotoninrezeptors 5-HT2C und die Hemmung des Noradrenalintransporters detailliert darstellen und die multimodale Pharmakodynamik des Arzneimittels hervorheben.
Das aktualisierte Etikett umfasst auch neue Stilldaten, die einen geringen Transfer von Qelbree in die Muttermilch zeigen, was es zum ersten ADHS-Medikament macht, das die nach dem FDA-Leitfaden von 2019 zu klinischen Stillstudien geforderten Nachvermarktungsanforderungen erfüllt. Die Studie, an der 15 gesunde stillende Frauen beteiligt waren, zeigte, dass die relative Säuglingsdosis etwa 1 % der täglichen Dosis der Mutter betrug.
Qelbree ist zur Behandlung von ADHS bei Patienten ab 6 Jahren zugelassen. Das Medikament enthält wichtige Sicherheitsinformationen, einschließlich des Risikos eines Anstiegs von Suizidgedanken und -handlungen, einer Erhöhung des Blutdrucks und von Veränderungen der Herzfrequenz.
- First ADHD treatment to meet FDA post-marketing requirements for lactation studies
- Label update demonstrates low transfer of drug into breastmilk (approximately 1% of maternal dose)
- Expanded understanding of drug's mechanism of action through new pharmacodynamic data
- Safety concerns include risk of suicidal thoughts and actions
- Multiple significant side effects including blood pressure and heart rate increases
- Contraindicated with several other medications including MAOIs
Insights
The FDA-approved label update for Qelbree represents a significant competitive advantage in the $17.7 billion ADHD market through two key developments:
- The new pharmacodynamic data demonstrating dual mechanism of action (5-HT2C partial agonist and norepinephrine reuptake inhibition) provides scientific validation of Qelbree's unique therapeutic profile, potentially supporting broader adoption among psychiatrists seeking non-stimulant options.
- Being the first ADHD medication to meet FDA's 2019 lactation study requirements creates a notable market differentiator, especially considering that approximately 4% of women of childbearing age have ADHD, representing a substantial untapped market segment.
The lactation study results showing minimal transfer to breast milk (~1% relative infant dose) could significantly impact prescribing patterns, particularly given the increasing focus on maternal mental health treatment options. This data may lead to preferred positioning in treatment algorithms for breastfeeding patients.
From a commercial perspective, these label updates strengthen Qelbree's market position in several ways:
- Enhanced differentiation from both stimulant and non-stimulant ADHD competitors
- Potential for expanded insurance coverage and improved reimbursement based on comprehensive clinical data
- Increased likelihood of inclusion in treatment guidelines for specific patient populations
The safety profile and multimodal mechanism position Qelbree favorably against other non-stimulant options like atomoxetine and guanfacine, potentially driving market share gains in both adult and pediatric segments.
- Updated label includes new data in Section 12.2, detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting Qelbree’s multimodal pharmacodynamics
- Qelbree is the first ADHD treatment to meet its post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies1
ROCKVILLE, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update for the label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data in Section 12.2. The updated label describes viloxazine’s partial agonist activity at the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, reinforcing its multimodal pharmacodynamic profile. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. Additionally, the updated label now includes new lactation data for breastfeeding women with attention-deficit/hyperactivity disorder (ADHD), showing that the transfer of Qelbree into breastmilk is low. Qelbree is approved for use in patients ages 6 years and older with ADHD.
“This label update and new data deepens our understanding of Qelbree, providing valuable insights to help support treatment decision-making for people living with ADHD,” says Dr. Stephen M. Stahl, M.D., PhD, DSc (Hon.) Distinguished Health Sciences Clinical Professor of Psychiatry and Neuroscience, University of California Riverside and Adjunct Professor of Psychiatry, University of California San Diego. “The updated pharmacodynamic data, which highlights viloxazine’s effects on the serotonin 5-HT2C receptor and inhibition of the norepinephrine transporter, adds depth to our understanding of Qelbree’s multimodal pharmacodynamics.”
The update to include lactation data in the label (Section 8.2) follows the 2019 FDA guidance suggesting lactation studies be conducted to inform breastfeeding with drug use recommendations and is based on a study involving 15 healthy lactating women.¹ The study evaluated the secretion of viloxazine and its metabolite (5-HVLX-gluc) into breast milk following a multi-dose (600 mg daily for three days) regimen of viloxazine. Results showed that the estimated daily infant dose (using a nominal infant body weight of 6 kg) of viloxazine and 5-HVLX-gluc was 0.085 mg/kg and 0.00595 mg/kg, respectively, and the relative infant dose was approximately
“By expanding Qelbree’s label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower healthcare providers and patients to make informed treatment decisions,” says Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We are committed to building the body of evidence surrounding Qelbree’s use within the ADHD space and providing an effective treatment option for those living with ADHD.”
INDICATION
Qelbree® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.
IMPORTANT SAFETY INFORMATION
Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.
You or your child should not take Qelbree if you or your child:
Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.
Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs.
Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania.
Do not drive or operate heavy machinery until you know how Qelbree will affect you or your child. Qelbree may cause you or your child to feel sleepy or tired.
The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed Warning and Medication Guide, for Qelbree here.
¹U.S. Food and Drug Administration. (2019). Clinical Lactation Studies: Considerations for Study Design. Guidance for Industry. Retrieved from https://www.fda.gov/media/124749/download.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments for attention-deficit hyperactivity disorder (ADHD), dyskinesia in Parkinson’s Disease (PD) patients receiving levodopa-based therapy, hypomobility in PD, epilepsy, migraine, cervical dystonia, and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.
For more information, please visit www.supernus.com.
Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s reporting on preliminary and exploratory open label clinical study on SPN-820, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s ability to conduct and progress product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-820 and SPN-830; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates including SPN-820; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates including SPN-820; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.
CONTACTS:
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591
Or
INVESTOR CONTACT:
Peter Vozzo
ICR Healthcare
(443) 213-0505
Peter.Vozzo@icrhealthcare.com
MEDIA CONTACT:
Catherine Fabiano
(646) 384-9617
Catherine.Fabiano@bcw-global.com
FAQ
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