Catalent Pharma Solutions, global provider of advanced delivery technologies and development solutions, has signed a commercial manufacturing agreement with Aucta Pharmaceuticals to formulate vigabatrin into a novel dosage form.
Handshake agreement
Under the terms of the agreement, Catalent undertook the FlexDose development programme, integrating the development of granulated drug product with stick-pack dose design, packaging and commercial manufacture of vigabatrin at its flagship European manufacturing facility in Schorndorf, Germany.
“Catalent has over a decade of experience in developing, manufacturing and packaging stick pack products, which offer a number of advantages to improve the convenience of dosing and patient adherence of drug products,” commented Jonathan Arnold, Catalent’s president, Oral Drug Delivery.
This will represent the first US Food and Drug Administration (FDA) abbreviated new drug application (ANDA) to employ Catalent’s FlexDose services and also the first to be commercialised in Schorndorf.
Vigabatrun for oral solution will be launched under the brand name Vigadrone by Aucta’s commercial partner, Upsher-Smith Laboratories. This new product will offer patients and physicians a fully substitutable generic alternative to Sabril (vigabatrin) powder for oral solution.