An independent Data Safety Monitoring Board (DSMB) recommended that Titan Pharmaceuticals’ Phase I/II trial of its ropinirole implant for Parkinson’s disease continue with a second cohort of patients. However, the company has decided to temporarily halt the study and focus on another asset.
An independent Data Safety Monitoring Board (DSMB) recommended that Titan Pharmaceuticals’ Phase I/II trial of its ropinirole implant for Parkinson’s disease continue with a second cohort of patients. However, the company has decided to temporarily halt the study and focus on another asset.
Ropinirole is a dopamine agonist that is currently available in daily or more frequently dosed oral formulations to treat symptoms of Parkinson’s disease and restless leg syndrome. It is usually prescribed with L-dopa to control serious motor complications and dyskinesias that show up in patients who have received L-dopa for several years.
Research has indicated that the side effects are linked to fluctuating medication levels of the oral formulations. Titan’s ropinirole implant, which was developed using its ProNeura drug delivery technology, is designed for long-term, continuous delivery of ropinirole HCL for Parkinson’s disease. This continuous delivery has the potential to minimize the motor complications patients on oral doses of the drug have.
The DMSB reviewed the data from the first cohort of patients and recommended the trial continue with a second cohort. The company has decided instead to focus on the commercialization of its Probuphine implant.
“We appreciate the DSMB’s recommendation to continue the study and evaluate the pharmacokinetic profile, safety and tolerability of our ropinirole implant, however, we have decided to temporarily postpone enrollment of the second cohort of patients in this study,” said Sunil Bhonsle, Titan’s president and chief executive officer, in a statement. “Our overriding priority over the next few months is to focus our resources on driving the commercial success of Probuphine implant, the first product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. Nevertheless, we remain very committed to adding value for our stockholders based on achievements with Probuphine and our other ProNeura-based products, such as our ropinirole implant. To that end, we intend to resume enrolling patients in this Phase I/II trial as resources allow.”
Probuphine is the only subdermal implant designed to deliver buprenorphine continuously for six months. Probuphine also uses the ProNeura drug delivery system. The company states, it “consists of a small, solid implant made from a mixture of ethylene-vinyl acetate and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in an outpatient office procedure and removed in a similar manner at the end of the treatment period.”
On May 30, Titan and Plymouth Meeting, Pennsylvania-based Braeburn terminated a December 2012 license deal that granted Braeburn exclusive rights to commercialize Probuphine in the U.S. and Canada. Titan regained all commercialization and clinical development rights in those territories. Braeburn paid Titan $1 million and will continue to assist the company through December 28, 2018.
Bhonsle said in a statement at the time, “We believe that Probuphine is an important product in the face of a growing opioid addiction epidemic and we will continue to explore options with the potential to improve uptake of the product in the U.S., as well as expand global access through partnerships in Europe and other territories with Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A and Knight Therapeutics Inc. in Canada.”
Braeburn’s president and chief executive officer, Mike Derkacz, indicated that as a result of the termination, it will be able to focus on its flagship Weekly and Monthly depot products.
Marc Rubin, Titan’s executive chairman, stated, “We are working closely with a team of addiction medicine experts to help position Probuphine for success through a focused market segmentation strategy. Meanwhile, we will ensure that Probuphine will continue to be available through established distribution channels for patients suffering from opioid use disorder.”
