Phenytoin Topical Project ready to enter phase III after meeting with the Dutch Medicines Evaluation Board

In June 2018, a so called Tailored Advice Procedure at the Dutch Medicines Evaluation Board was initiated regarded the next developments steps of topical phenytoin cream. The aim of such development is to obtain registration for topical phenytoin cream in Painful Diabetic Neuropathy.

This tailor-made advice is customized advice mainly aimed at start-ups, small businesses and academic groups. In general, the advice will primarily relate to the early stage of development (pharmaceutical or pre-clinical aspects, phase I clinical research), although in the case of topical phenytoin cream the project was also eligible at a later stage (before entering phase III). Drug Rediscovery is frequently a topic; this involves the development and registration of a new application of an existing medicine, as in the phenytoin case. During such advice, questions can be asked about the ‘regulatory road map’, for example towards Europe.

Such meetings are primarily intended to advance, in an informal setting, to an effective exchange of (scientific) insights and gives both the applicant and the experts of the Dutch MEB the opportunity to ask for specific aspects or to provide further explanation.

The input given by the Dutch agency will be instrumental for the development of a crisp and clear phase III development, for which preparations currently are already underway. First discussions related to phase III are held at one of the Academic hospitals in Amsterdam.

Due to these developments TI started to look seriously for partners on either a local or global base. The partner would take up the last development step and become responsible for registration, marketing and sales. Further information: