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 (IS)—monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
- Refractory Complex Partial Seizures (CPS)—adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; Vigadrone is not indicated as a first line agent.
“At Upsher-Smith, we understand that physicians want to begin treating infantile spasms quickly upon diagnosis,” said Rusty Field, president and chief executive officer of Upsher-Smith. “We are supporting Vigadrone with our Access Pathways Program to help ensure that physicians will be able to start their patients on Vigadrone as quickly, and as seamlessly, as possible.”