Clinical Trial Okayed for Parkinson’s Drug Implant

(Science360.gov)

24 August 2017. A maker of implants for long-term release of drugs to treat chronic diseases says the Food and Drug Administration approved a clinical trial to test its implant for Parkinson’s disease. The drug delivery mechanism is made by Titan Pharmaceuticals Inc. in South San Francisco, California with a process already in use for treating opioid addiction.

Parkinson’s disease occurs when the brain produces less of the substance dopamine, a neurotransmitter that sends signals from one neuron or nerve cell to another. As the level of dopamine lowers, people with Parkinson’s disease become less able to control their bodily movements and emotions. Symptoms include tremors, i.e. shaking, slowness and rigidity in movements, loss of facial expression, decreased ability to control blinking and swallowing, and in some cases, depression and anxiety. According to Parkinson’s Disease Foundation, some 60,000 new cases of Parkinson’s disease are diagnosed in the U.S. each year, with more than 10 million people worldwide living with the disease.

Titan has one drug implant, Probuphine, approved by FDA in May 2016 for treatment of opioid addiction. Its basic technology, known as Proneura, creates a small solid plastic stick implanted under the skin to release drugs in a continuous controlled manner. The company mixes the drugs with the flexible polymer ethylene-vinyl acetate, found in a variety of consumer and industrial products, as well as medical applications.

The Proneua stick is usually implanted in the upper arm in an office procedure, where it dispenses the medication for 6 to 12 months. The stick can be removed or replaced also in an office or outpatient procedure. The company says drugs administered with Proneura sticks enter the blood stream continuously, similar to an intravenous infusion, avoiding fluctuations, peaks, and troughs experienced by some patients taking pills or capsules.

Titan’s Parkinson’s disease implant dispenses the drug ropinirole through a Proneura stick. Ropinirole is in a class of drugs called dopamine agonists that replace the missing or depleted dopamine in people with Parkinson’s disease to treat its symptoms, but is not a cure. The company says some Parkinson’s disease patients taking ropinirole in pill or capsule form experience peaks or troughs of the medication resulting in involuntary movements or tics called dyskinesia and other motor control complications.

The early-stage clinical trial is expected to enroll some 20 individuals with Parkinson’s disease in the U.S. to ascertain the safety and tolerability of the ropinirole implants and document chemical effects of the drug on the body. The study will also track any changes in functioning or quality of life on standard rating scales to evaluate Parkinson’s disease patients. Participants will be asked to substitute a ropinirole implant for three months, instead of taking their regularly prescribed stable-dose ropinirole.

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