After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant. Titan also needs to identify a principal investigator for the study, although the company said it is in the process of qualifying the participating clinical sites.
Titan said it plans to have final test data of its implant and the applicator within the next few weeks.
“We understand the FDA’s diligence and respect its request for additional information,” executive VP & chief development officer Kate Beebe said in prepared remarks. “We are working quickly to provide the FDA with the additional information required, and are hopeful that we will be able to commence the clinical study toward the end of the 2nd quarter.”
The company’s ropinirole implant is designed to deliver sustained doses of the dopamine agonist for at least 3 months at a time in patients with Parkinson’s disease. Continuous dopaminergic stimulation may alleviate motor complications and delay the onset of the involuntary movements associated with the neuro-degenerative disease, according to Titan.
The company’s long-term, continuous drug delivery platform, ProNeura, was developed to address chronic diseases, including addiction. Probuphine, the company’s 6-month buprenorphine implant for the maintenance treatment of opioid addiction, is the 1st marketed product to provide maintenance treatment continuously for 6 months following a single administration procedure.