Gocovri Approved by FDA as 1st Treatment for Levodopa-induced Dyskinesia in Parkinson
 

Gocovri Approved by FDA as 1st Treatment for Levodopa-induced Dyskinesia in Parkinson’s Patients

First Parkinson's Drug for Levodopa-induced Dyskinesia Approved by FDA

Isn't Gocovri Amantadine?

YEP, it's amantadine, very expensive amantadine.
"Other Name: amantadine HCl extended release"

Open-Label Safety Study of ADS-512 in PD Patients With LID - Full Text View - ClinicalTrials.gov

subcutaneous ropinirole is in the works that will last for months.
SOUTH SAN FRANCISCO, Calif., Aug. 24, 2017 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (TTNP) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's disease. The Phase 1/2 clinical study in patients will commence shortly.

The trial is an open-label, sequential, dose escalation study that will enroll approximately 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.

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Yes, as soccertese said, it's going to be a very expensive version of Amantadine. This will be a once-a-day (taken before bedtime) extended release version. It will cut down the number of pills taken. It is supposed to also reduce some of the Amantadine side side effects. However, the trials never tested Gocovri against regular Amantadine. It was only tested vs Placebo. So, we really don't know for sure if it has fewer side effects. It will be highly priced, so, unless insurance covers a good percentage of the cost, it's hard to see why I would switch from regular Amantadine to the new ER version.

One side note, many people may not realize that amantadine has never been FDA approved for use in PD. All of us who take it are doing so off-label. So, at least this now puts an official approval to the drug for use in PD.

The doctor prescribed Amantadine for my tremor but I have not gotten up the nerve to take it yet. The side effects just put me off. That may be foolish but I just can't take it yet.

I've been taking it for almost six years with no side effects at all. The only way to find out is to try it.

My thanks go to NewsBot for pointing me to this:

Adamas Pharma says its new Parkinson’s drug isn’t just a more expensive, long-acting version of generic - MarketWatch

"Gocovri is a new formulation of amantadine, at a new price: between $10,000 and $30,000 a year."

'... Chief Executive Greg Went and Chief Medical Officer Rajiv Patni emphasized that there are other important differences. Gocovri is “not a convenience play” but rather a new chemical entity that is designed to be more effective, they said; moreover, the product represents 13 years and “well over” $100 million in investment.'

For sure there is a different release mechanism, but does anyone know how Gocovri differs chemically from amantadine?

John