Qelbree’s Delivery System

IMPORTANT SAFETY INFORMATION

Please see full Important Safety Information to the left.

Qelbree’s Delivery System Provides Rapid and Extended Release of Viloxazine^1,2

Qelbree^® (viloxazine extended-release capsules) is an FDA-approved medication indicated to treat Attention-deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.¹

Qelbree is the first nonstimulant therapy that has been approved for adults with ADHD in 20 years.¹ It is also the first 2-bead Microtrol™ technology delivery of viloxazine for rapid and extended release for full-day exposure (Figure 1).^1,2

2-bead Microtrol^TM Technology Delivery

Microtrol™ is a controlled release platform that can provide a broad range of dose and release profiles tailored to a particular compound. This enables Qelbree to be dosed once-daily (Figure 1).² The sprinkle option provides an accessible route of administration, which may be advantageous for patients who have trouble swallowing pills.¹

Figure 1. The first 2-bead Microtrol™ Technology delivery of nonstimulant viloxazine for 24-hour patient exposure^1,2

Artist rendition.

The 2-bead Microtrol^TM technology delivery also provides pharmacokinetic advantages such as full-day 24-hour patient exposure. Microtrol^TM minimizes variability in peak-to-trough plasma concentrations and provides consistent plasma levels that last throughout the day.²

Qelbree Mechanism of Action and Pharmacokinetics

Qelbree contains viloxazine, a selective norepinephrine reuptake inhibitor. The viloxazine hydrochloride in Qelbree is a water-soluble powder formulated as oral capsules.¹ Qelbree is thought to treat ADHD by inhibiting the reuptake of norepinephrine; however, its mechanism of action is not fully known.¹

The pharmacological properties of an oral ER formulation of viloxazine were evaluated in a single-center, open-label, randomized, 2-period, 2-sequence crossover study in healthy adults.²

Compared to an IR formulation, viloxazine ER has a relative bioavailability of approximately 88%. The median time to peak plasma concentration following a single 200 mg dose is approximately 5 hours, and a steady state is reached after 2 days of daily administration. The half-life of Qelbree is approximately 7 hours.¹

The pharmacokinetics data of Qelbree demonstrate a gradual release for extended exposure throughout the day, with smooth tapering at the end of the dosing interval (Figure 2).²Therefore, once-daily Qelbree provides full 24- hour exposure.²

Figure 2. 24-hour mean SS plasma concentration-time profile (N=28)²

SS=SteadyState

No Evidence of Abuse Potential^1-3

In the Qelbree clinical trials, there were no reports of withdrawal symptoms or signs of dependence as adverse events during human clinical trials.¹ In addition, viloxazine was found to be free of physical drug dependence in 5 animal models of abuse liability.³ Taken together, these data indicate that in clinical trials Qelbree shows no evidence of abuse and therefore may carry a minimal risk of treatment abuse.

IMPORTANT SAFETY INFORMATION (CONT'D)

CONTRAINDICATIONS

• Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis

• Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

Please see full Important Safety Information to the left.

Please see full Prescribing Information, including Boxed Warning.

Learn more about Qelbree, an extended-release, nonstimulant medication for ADHD: https://www.QelbreeHCP.com/

References

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Data on file. Supernus Pharmaceuticals, Inc.
3. Yanagita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmiochem Behavacol B. 1980;12:155-161.

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