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Catalyst To Continue Ruzurgi
For patients who have been on Ruzurgi and then moved to Firdapse, this should be good news for you, if you want to go back on Ruzurgi.
From an inquiry I made to them, they sent a letter with this good news to share with the LEMS community. According to the response, Catalyst has transferred the existing inventory of amifampridine-free base to their distribution center and is resuming distribution to existing investigator IND sites and currently treated patients, free of charge.
To provide Ruzurgi ongoing in the future, Catalyst Pharmaceuticals is actively seeking a new, qualified manufacturing facility for the amifampridine-free base. Having worked in a blood bank, heavily regulated by the FDA, I have experienced the careful testing, procedures, and policies in place and the requirements to meet. I’m sure it’s the same for medication manufacturers too.
No time frame to manufacture and distribute new production of amifampridine free base was in their information. Finding and setting up a manufacturing facility and quality systems for testing take time. They also have to begin the manufacture, prove out their testing procedures, set up distribution for delivery, and begin the process.
Because of the limited remaining investigational amifampridine free base on supply, they are not adding additional investigator INDs or patients being treated under those INDs. They feel their current inventory is adequate to supply those patients currently receiving the medication.
We’ll let you know when we hear any news on a timeline for adding more investigator INDs and the new manufacture has commenced for Ruzurgi.
As always, be your own best patient advocate. Patients are encouraged to discuss treatment options with their physicians. Keep your medical team informed and work together with them to put together the best treatment plan possible.
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9 Replies
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This is really good news Price. I have had at least 7 days since I started taking Firdapse where it just doesn’t “hit” when I take it – even going back to bed for it to work. I’m also considerably weaker. It’s extremely frustrating.
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Yes, I was so excited to get this info from them. I hope when it becomes available you will benefit.
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Thank you Price. I’m really struggling with Firdapse so this is good news.
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I certainly hope it’s true. I think it’s wishful thinking that Catalyst will supply Ruzurgi for all patients who need it. I can’t take Firdapse and need Ruzurgi. I’m not sure what I’m supposed to do until they figure out the logistics of it all. It will be an easy out for them if they can’t find a place to produce it. Just my opinion.
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I was told by catalyst that anyone who can’t take Firdapse, was able to get on the Ruzurgi while supplies last. It’s worth asking.
I truly hope they can bring back ruzurgi in the way it was made before, no modifications. It just worked better imo. I found just this week that firdapse works better on an empty stomach, or with very little food. If I try to take Firdapse on a completely full stomach, the medicine hardly works at all. This is been a huge deal in my day-to day feeling much better if I take it before lunch/dinner versus after.
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I’m glad you’ve found a delivery method for Firdapse that works better for you.
Per their letter to me, they have “resumed distribution to existing investigator IND sites and their currently treated patients”.
They continue, “we cannot add additional investigator INDs or patients being treated under those INDs” due to their current limited inventory.
I spoke with them just today and they have assured me when they have a more definite timeline to resume production, I will know and can pass it along here at BioNews.
We hope you continue to work with your healthcare team to keep your treatment plan effective for you.
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The topic post is based directly from the letter I received. Setting up a new manufacture and getting it to production will take an indeterminate time (when they released this info). At some point I expect they’ll have a much better idea of the timeline. When they have that information and I get it, we will share it here.
As with all things medical we encourage everyone to work with their neurologist and medical team for your best personalized treatment plan.
Should you need more information directly from Catalyst, you can contact Ken Ecker, Executive Director of Medical Affairs, at 305-420-3262. -
Price,
Do you have an email address for Ken Ecker?
Ginny
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I do not. You can contact him at 305-420-3262.
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Thank you Price. I can probably fashion it off of Pat McEnany’s email address.
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I do not. You can contact him at 305-420-3262.
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