Titan Pharmaceuticals’ stated today that their ropinirole implant, designed to treat the symptoms of Parkinson’s disease, was cleared by the FDA today as a new drug application.

FDA clears Titan Pharmaceuticals' investigational new drug application, for its ropinirole implant designed to treat the symptoms of Parkinson’s disease.

The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, according to the South San Francisco, Calif.-based company.

“New treatments that offer continuous delivery of medication providing non-pulsatile stimulation of dopamine receptors in the brain appear to have some advantages over oral formulations,” principal investigator Dr. Aaron Ellenbogen said in prepared remarks. “The ProNeura implants with ropinirole could potentially offer an important treatment option for continuous drug delivery that overcomes the fluctuating drug levels associated with oral administration of ropinirole, and we look forward to conducting this study.”

The implant uses Titan’s ProNeura technology to continuously deliver ropinirole HCL. Ropinirole, a dopamine agonist, is commercially available in a daily oral formulation to treat symptoms of Parkinson’s disease, including stiffness and tremors.

“While oral formulations of ropinirole have greatly benefitted those suffering from Parkinson’s disease, many patients develop serious motor complications and dyskinesias after several years, due to the peak-trough fluctuations of medication in the blood,” Kate Beebe, Titan’s EVP & chief development officer, added. “Our ropinirole implant is designed to provide continuous, non-fluctuating therapeutic levels of medication for up to three months, potentially offering patients and clinicians a more effective treatment option. We thank the FDA for their timely review and comments on the IND and clinical protocol.”

In February, the FDA put a hold on the clinical trial of its ropinirole implant and requested that Titan submit more information to the federal watchdog.

After it completed an initial review of the implant’s IND application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant.

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.