The FDA has cleared an IND application by Titan Pharmaceuticals (NASDAQ:TTNP) for its ropinirole implant intended to treat the signs and symptoms of Parkinson's disease.
A Phase 1/2 clinical study in patients will commence shortly. The open-label, sequential, dose escalation study will enroll some 20 subjects with idiopathic Parkinson's disease across three or more U.S. research sites.
The primary objectives are to characterize the pharmacokinetic profile of the ropinirole implants, to evaluate their safety and tolerability, and to explore potential signals of efficacy using established disease-specific assessment scales. Patients on a stable dose of L-dopa plus oral ropinirole will have their oral ropinirole switched to ropinirole implants for three months of treatment.
The ropinirole implant was developed with Titan's ProNeura technology. It is designed for the long-term, continuous delivery of ropinirole HCL for the treatment of signs and symptoms of Parkinson's disease, including stiffness, tremors, muscle spasms, and poor muscle control.
Ropinirole is a dopamine agonist currently available in daily or more frequently dosed oral formulations for the treatment of Parkinson's disease symptoms and restless leg syndrome.
"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, EVP and chief development officer, said in a statement.
"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,” she added.
Dr. Aaron Ellenbogen of the Michigan Institute of Neurological Disorders, and the principal investigator at the first trial site, near Detroit, said 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.
"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,” he added.
The FDA previously approved Titan’s lead implant, Probuphine, the first and only commercialized treatment of opioid dependence, which provides continuous blood levels of buprenorphine for six months following a single procedure.