Per the agreement, Catalant has undertaken the development of FlexDose packaging and integrated the development of the granulated drug product with stick-pack dose design. Catalant will also package and manufacture vigabatrin in its manufacturing facility located in Schorndorf, Germany.
Vigabatrin is a prescription medication used for infantile spasms and refractory complex partial seizures for adults and children over 10 years. A Catalent spokesperson told us that the stick pack, a packet that contains granulated, liquid, or gel formulations, format is preferred for this type of treatment because it offers convenience.
Vigabatrin will be the first US Food and Drug Administration (FDA) abbreviated new drug application (ANDA) to employ Catalent’s FlexDose services.
The spokesperson explained, “Having already worked together on the development and clinical supply phases, this agreement helps Aucta to avoid the cost of a technical transfer and to ensure seamless and reliable supply for the product.”
Aucta’s commercial partner, Upsher-Smith Laboratories will launch vigabatrin for oral solution as Vigadrone. This will offer patients and physicians a generic substitute for Sabril, the branded version of the drug.
“Prescription and OTC medicines can be taken from a stick pack hygienically and without water, and granules, powders, and gels are often easier to swallow than an equivalent hard tablet – and yet offer similar dose control and dose uniformity,” said the Catalent spokesperson.
We recently reported that Catalent completed a merger with Juniper, making the latter a wholly owned subsidiary by the former. This acquisition was in part to strengthen Catalent’s oral dose manufacturing capabilities.