Before a medication like VIGAFYDE™ (vigabatrin) can be approved for public use, it must undergo rigorous clinical testing to ensure safety, efficacy, and proper dosing guidelines. Although vigabatrin itself has been studied for years, the approval of VIGAFYDE™—the first ready-to-use liquid formulation—was based on a series of clinical evaluations demonstrating that this form provides the same therapeutic benefit as previously approved vigabatrin products, with added advantages in administration and dosing accuracy. Click here to explore vigabatrin suspension.

The clinical data supporting VIGAFYDE™ are largely derived from bioequivalence studies comparing it to the traditional powder for oral solution. These studies were conducted in both adult and pediatric populations to assess whether the liquid formulation achieved similar levels of vigabatrin in the bloodstream (pharmacokinetics). Results confirmed that VIGAFYDE™ delivers the same active compound with consistent absorption and distribution, supporting its approval as a therapeutic equivalent.

In addition to pharmacokinetic studies, VIGAFYDE™'s development leveraged the established safety and efficacy profile of vigabatrin for seizure control. Previous clinical trials had already demonstrated that vigabatrin significantly reduces or eliminates spasms in many infants diagnosed with infantile spasms, particularly those with tuberous sclerosis complex (TSC). These findings were pivotal in making vigabatrin a first-line treatment in many pediatric epilepsy protocols.

Because of its liquid form, VIGAFYDE™ offers practical improvements, particularly in younger patients. Trials and real-world studies emphasized ease of use, improved caregiver adherence, and greater confidence in dosing precision. For parents and healthcare providers dealing with complex seizure disorders in infants, these advantages can make a substantial difference in daily treatment routines.

Despite its effectiveness, the trials also reinforced the need for visual monitoring due to the risk of permanent vision loss. Data collected over years of vigabatrin use helped regulators understand the scope of this risk, leading to the REMS program that remains in place for all vigabatrin products, including VIGAFYDE™. The consistent finding across studies is that while vision loss is a serious concern, the benefits of seizure control often outweigh the risks, especially when vision is monitored closely.

In summary, the clinical trial data behind VIGAFYDE™ confirm its value as a new formulation of a well-established treatment. It matches the therapeutic performance of traditional vigabatrin while offering improved usability—especially for infants and caregivers navigating the early and critical stages of seizure management.