Save the Date: FDA Narcolepsy Public Meeting on Sept 24, 2013

by julie on August 5, 2013

FDA NARCOLEPSY PUBLIC MEETING PATIENT FOCUSED DRUG DEVELOPMENT September 24 2013Interested in shaping future narcolepsy drug development? Here’s your chance! On September 24, 2013, FDA will host the Narcolepsy Public Meeting to obtain patients’ perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy.

FDA Narcolepsy Public Meeting Patient Focused Drug Development ContributeThis past year, we worked together to secure this tremendous opportunity with FDA. The September 24 meeting gives patients the power to shape the future of narcolepsy drug development. 

Patient participation will be essential for success. Patients can contribute in person, via webcast or public docket.

Stay tuned:

I am working with policy experts on an exciting plan of action. Details coming soon! Please feel free to contact me (remrunner01@gmail.com) if you’re interested in getting involved or have any questions. 

Save the Date:

When: September 24, 2013 from 1:00 PM to 5:00 PM (EDT)
What: FDA Narcolepsy Public Meeting on Patient-Focused Drug Development
Where: Attend in person OR by webcast – REGISTRATION is FREE (register by Sept. 13, 2013)
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503 A
Silver Spring, MD 20993
Who: Narcolepsy Patients & Patient Stakeholders
Why: To help shape future narcolepsy treatment options by providing FDA with patient perspective on the impact of narcolepsy on daily life as well as the available therapies.

REGISTRATION
PUBLIC COMMENT DOCKET

For more about the FDA Initiative, click here.

{ 8 comments… read them below or add one }

Lloyd August 5, 2013 at 1:07 pm

Hi Julie. Will flumazenil, a drug showing hope for those with Narcolepsy without Cataplexy and those with Idiopathic Hypersomnia be on the agenda? Lloyd

Reply

julie August 5, 2013 at 2:10 pm

Hi Lloyd,
Thank you for your great question. The focus of the meeting will be on helping FDA understand the variety of narcolepsy symptoms, various disease states, impact on quality of life and patient experience with current treatments – so that when a drug like flumazenil enters FDA approval process, FDA better understands what matters most for patients for clinical end points, etc. This is a unique opportunity to educate FDA on patient experience and with great participation from folks with N+C and N-C, our goals will be furthered. Thanks again, Julie

Reply

noddyboddy August 5, 2013 at 8:02 pm

I wish there would be research on cognitive dysfunction and a recognition that narcolepsy has more symptoms than just the classic tetrad. I lose attention, can’t remember things, can’t concentrate, get confused and disoriented before the descending spiral results in a sleep attack. This makes it extremely difficult to learn anything — so I am constantly frustrated with the every changing facets of technology and can’t keep my skills up to date because I can’t learn fast enough. I forget even commonly used details and have to look them up in the manual again. I’ve had narcolepsy for 37 years and can no longer take stimulants. New approach, please!

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cheryl August 6, 2013 at 6:08 pm

The focus should be on replacement of what’s missing in our brains (hyporetin-1/orexin-a) NOT more pills treating symptoms from not having it!!
Hcrt/Orx is easily made & readily available from lots of Neuropeptide Company’s all over the world. And technically has gone through two clinical trails on humans. That WE the taxpayer have doled out. #1: Through intranasal therapy (only 8 people) SLEEPMEDICINE Vol12 Issue10 pages 941-946 Dec 2011. (also known as )ClinicalTrials ID NCT00484757.
#2: Used on dozens of healthy U.S. Troops by D.A.R.P.A. 2007 trying to keep them awake for 2 weeks straight. Good luck finding results (try WIRED mag.
“Snorting Sleep”) The question is: Which Big Pharma bought the rights from
D.A.R.P.A. for this therapy and then can sit on this Orexin-A therapy for as long as they like! Who makes the most billions selling us symptom pills?

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Allison August 6, 2013 at 6:15 pm

I plan on being there. I submitted my answers to be on the panel.

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Chelsea August 10, 2013 at 2:42 pm

I can’t be there in person, but will partocipate via web/phone etc. This is an amazing opportunity!! How many people do you know that are ill and have had a sit down with the FDA to tell them how they can help treat their illness…? I don’t know anyone! Thank you Julie for your efforts, your voice carries that of thousands of other PWN.

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Holly Twedt September 17, 2013 at 2:29 pm

I want to tell them that I am on FMLA due to my employer questioning if I am fit for duty due to cognitive functioning problems. Have had to see a psychiatrist and a neuropsychologist for evaluation. Failed the evaluation and now they are trying to imply I may have dementia. Now have to go thru physical tests to rule out. I am trying to comply but question what my next step will be as there is no room for discussion about the role the narcolepsy has made on my functioning due to side effects from medications, job stress, etc.

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John Hay September 19, 2013 at 4:14 pm

I missed the deadline for registration. What sort of webcast is it that I will not be able to monitor on the web?

Reply

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