FDA Approves New Drug for Parkinson's

The U.S. Food and Drug Administration (FDA) has approved RYTARY™ (pronounced rye-TAR-ee), a new, extended-release formulation of carbidopa-levodopa, for the treatment of several different types of parkinsonism, including:

• Idiopathic Parkinson’s disease (PD),
• Post-encephalitic parkinsonism, and
• parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

Fred Wilkinson, president and CEO of Impax Laboratories, which manufactures RYTARY, released this statement:

…RYTARY…provides an extended-release carbidopa-levodopa product that treats Parkinson's disease.  RYTARY is designed to address one of the most significant unmet needs for patients living with Parkinson's disease, which is to reduce the amount of time during the day when their symptoms are not adequately controlled. 

RYTARY combines a mixture of immediate and extended-release carbidopa/levodopa. It consists of dozens of tiny beads in a gelatin capsule.  RYTARY can be taken as the capsule or the capsule can be opened and the beads mixed with an easier to swallow substance such as applesauce.

In clinical trials*, RYTARY showed positive changes in the ability of patients with PD ability to perform activities of daily life and increased motor skills as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 30 weeks (or early termination).  In addition, in patients with advanced PD, treatment with RYTARY reduced the percentage of "off" time compared with immediate-release carbidopa-levodopa and increased "on" time.  During the increased “on” time, there was no increase in troublesome dyskinesia, a common side effect in PD patients taking large doses of carbidopa/levodopa.

The most common adverse reactions of subjects involved in the clinical RYTARY trials were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

RYTARY is expected to be available for commercial distribution in February 2015.

Please see the attached release sheet from the FDA.

If you are interested in adding RYTARY to your PD medication regimen, please consult your neurologist.

Stay Active!

PDCRC Team 

*Cited from Clinical Studies- Sections 14.1-14.2- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf

 

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf

UCSF Center of Excellence Resources

We here at the Parkinson's Disease Clinic and Research Center (hereafter known as the PDCRC) would like to let you know about a number of resources available through the National Parkinson Foundation (NPF).  

We have been in partnership with the NPF for many years and are proud to have been selected as one of their Centers of Excellence (COE).  To be a COE means that our movement disorders clinical staff meets rigorous criteria for research, comprehensive care delivery, professional education and patient outreach services.

The NPF (http://www.parkinson.org/) has been a forefront in the fight against Parkinson's for more than half a century.  They fund critical research and support services,  provide education and outreach to the community and promote a comprehensive approach that addresses the whole person and the full range of symptoms of the disease.  In addition, the NPF hosts several walks and movement days each year, designed to encourage movement and activity for those with PD, and raise public awareness and critical research funds.

The NPF has developed a series of manuals that highlight aspects of the disease, called rainbow books (each volume is a different color), which are extremely useful to both patient and caregiver.  

If you have not already done so, take a moment to explore the NPF website and consider attending one of their many activities. It provides a wealth of knowledge and support for PD patients and caregivers.

Stay Active!

PDCRC Team

A New PD Community Blog

Thank you for stopping by!

We are excited about this new format for keeping you all informed and educated about new opportunities for Parkinson patients, caregivers and advocates.  We at the UCSF Parkinson's Center want to create a new way to update and showcase events in the community as we discover them, as well as post specific updates about Parkinson's disease.

We hope that you will find this blog to be a useful resource.

Stay Active!

PDCRC Team.