FDA Approval of Vyvanse (Lisdexamfetamine)
Vyvanse (lisdexamfetamine dimesylate) was first approved by the FDA in 2007 as a treatment for ADHD.
Background and Development
Lisdexamfetamine dimesylate (LDX) was developed as the first prodrug stimulant for treating ADHD. It was designed with unique pharmacokinetic properties that differentiate it from other stimulant medications:
- It remains pharmacologically inactive until enzymatic processes predominantly associated with red blood cells convert it to the active ingredient, d-amphetamine, and the amino acid lysine 1
- This prodrug design allows for once-daily dosing with approximately 12 hours of activity 2
- The unique conversion mechanism was intended to provide additional safety regarding abuse potential compared to immediate-release stimulants 2
FDA Approval Timeline
- 2007: Initial FDA approval for treating ADHD in children aged 6-12 years 3, 2
- 2008: FDA approval extended to adults with ADHD 4
- Later approvals expanded its indications to include moderate to severe binge eating disorder in adults 3
Clinical Significance
Lisdexamfetamine has demonstrated significant efficacy in treating ADHD:
- Studies show it reduces ADHD rating scale scores by approximately 27 points in children and 19 points in adults 2
- It provides efficacy for a full treatment day, with effects lasting up to 14 hours post-dose in adults 1
- The medication has shown improvements in executive function across all approved doses (30-70 mg daily) 1
Safety Profile and Considerations
The safety profile of lisdexamfetamine is consistent with other long-acting stimulants:
Common adverse effects (>10% incidence) include:
As with other CNS stimulants, important safety considerations include:
- Potential cardiovascular effects (increased blood pressure and heart rate)
- Growth suppression in pediatric patients
- Risk of abuse and misuse 3
Current Place in Therapy
Lisdexamfetamine is now considered among the first-line pharmacological treatments for ADHD:
- It's included in treatment guidelines as an FDA-approved medication for ADHD in patients 6 years and older 5
- The American Academy of Pediatrics recommends FDA-approved medications, including stimulants like lisdexamfetamine, as part of a comprehensive treatment approach 5
- Its once-daily dosing provides convenience and potentially improved adherence compared to multiple-dose immediate-release formulations 1
The development and approval of Vyvanse in 2007 represented an important advancement in ADHD pharmacotherapy, offering a novel prodrug approach to delivering d-amphetamine with potentially reduced abuse liability and extended duration of action.