The product was approved by the U.S. Food and Drug Administration (FDA) on June 21, 2018. The Vigabatrin powder market had U.S. sales of approximately $333 million for the 12 months ending December 31, 2017, according to IQVIA. Upsher-Smith partnered with Aucta Pharmaceuticals, LLC for product development and manufacturing.
Vigadrone is indicated for the treatment of infantile spasms—monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss—and refractory complex partial seizures—adjunctive therapy in patients 10 years and older who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. The product is not indicated as a first line agent.
Because Vigadrone might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.
Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe Vigadrone and patients must be enrolled in the Vigabatrin REMS Program to receive Vigadrone. All certified prescribers and enrolled patients in the Sabril REMS Program have been transitioned to the Vigabatrin REMS Program and do not need to recertify or re-enroll.
*Sabril is a registered trademark of Lundbeck.
(Source: Upsher-Smith Laboratories, LLC)
Filed Under: Drug Discovery