Titan puts Parkinson's disease implant trial on hold after FDA asks for more data
The US firm announced “initiation of the clinical trial” was on hold in an SEC filing, explaining that move would allow it to submit request information to the US regulator.
Titan said: “The FDA indicated that it will require final release test data on the ropinirole implant and the applicator used to insert the implant before clearing the IND.”
The FDA has also asked Titan to appoint a principal investigator for the study.
Titan said the final test data on the implant and applicator will be available in a few weeks, adding that it is in the process of selecting trial sites.
The implant is based on Titan’s proneura delivery platform, which is designed to deliver steady levels of the dopamine agonist ropinirole for periods of three to six months.
