8-K: Supernus Announces Qelbree Label Update with New Pharmacodynamic and Breastfeeding Data

Supernus Pharmaceuticals receives FDA approval for a Qelbree label update, including new pharmacodynamic data and information for breastfeeding women.

Summary

• Supernus Pharmaceuticals announced that the FDA approved a label update for Qelbree, a non-stimulant ADHD treatment.
• The update includes new pharmacodynamic data detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition.
• The label now includes lactation data for breastfeeding women, showing low transfer of Qelbree into breast milk.
• A study involving 15 healthy lactating women showed that the estimated daily infant dose of viloxazine and its metabolite was low, approximately 1% and 0.07% of the weight-normalized maternal daily dose, respectively.
• Qelbree is approved for use in patients ages 6 years and older with ADHD.

Sentiment

Score: 7

Explanation: The sentiment is positive due to the FDA approval of the label update and the inclusion of new data that supports the use of Qelbree in breastfeeding women. However, the potential risks associated with Qelbree, such as suicidal thoughts and increased blood pressure, temper the overall sentiment.

Positives

• The label update provides healthcare providers and patients with more information to make informed treatment decisions.
• The inclusion of lactation data addresses a key consideration for breastfeeding mothers with ADHD.
• The new pharmacodynamic data deepens the understanding of Qelbree's mechanism of action.
• The study showed that the transfer of viloxazine into breastmilk is low.

Negatives

• The study did not specifically evaluate the effects of viloxazine on breastfed infants or milk production, nor is there additional data regarding these effects.
• Qelbree may increase suicidal thoughts and actions, especially within the first few months of treatment or when the dose is changed.
• Qelbree can increase blood pressure and heart rate.

Risks

• Qelbree may increase suicidal thoughts and actions in children and adults with ADHD.
• Qelbree can increase blood pressure and heart rate, requiring monitoring by a doctor.
• Qelbree may cause manic episodes in patients with bipolar disorder.
• The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

Supernus Pharmaceuticals is 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.

Management Comments

• Dr. Stephen M. Stahl stated that the label update and new data deepens our understanding of Qelbree, providing valuable insights to help support treatment decision-making for people living with ADHD.
• Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, said that by expanding Qelbrees 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.

Industry Context

The label update aligns with the FDA's 2019 guidance on Clinical Lactation Studies, reflecting a growing emphasis on providing data to inform breastfeeding recommendations for medications.

Comparison to Industry Standards

• Qelbree is the first ADHD treatment to meet its post marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies.
• Other pharmaceutical companies such as Pfizer, Eli Lilly, and Johnson & Johnson also conduct post-marketing studies to update drug labels with new safety and efficacy data.

Stakeholder Impact

• Healthcare providers will have more information to make informed treatment decisions for patients with ADHD.
• Patients, especially breastfeeding mothers, will have more data to assess the risks and benefits of Qelbree.
• Shareholders may react positively to the news of the label update.

Key Dates