Tinnitus Talk Support Forum

I'll try to update you and others asap

@ErikaS Have you already seen Waitjustchillin's post in the Retigabine thread? I have to admit that it's quite a bummer. It seems like we have to wait for phase 2/3 results before we can get our hands on it

However, I am a bit stuck with this part of their answer concerning safety, efficacy and/or rationale:

''Although there is potential to treat tinnitus as you mentioned below, at this time we have limited clinical data, safety data, and/or rationale to offer expanded access for patients.''

The and/or part is a bit confusing here, since it creates different interpretations about their motive to not offer EA at this moment. They may have a point about safety/efficacy, though it hasn't stopped one company from offerring their treatment via EA while it was being tested in phase 2 (https://mytomorrows.com/en/blog/case-study-expanded-access-program-non-small-cell-lung-cancer-nsclc)

Concerning the rationale part: maybe it's not a smart move to ask my doctor and MT about applying for EA, but I wonder if there's a chance that MT's involvement may nudge them in a more favourable position towards our demands if offered a clear strategy (e.g. group access, reducing bureaucratic obstacles, clinical sites, data collection of real world data, competitive advantage vs. Xenon, etc.).

So I want to know if we can convince Biohaven by going down the 'rationale' avenue. This may seem like an act of desperation, but there's no way of knowing until we've tried all means that are at our disposal, right?

I am honestly distraught to say the least. And yes, I saw/read his response from Biohaven right after I pulled a tick off my stomach, first tick ever and I live in Northeast USA so Lyme is very common. Literally two gut punches within 30 minutes. And yes taking Doxycycline should protect me if tick is positive for Lyme, but OF COURSE Doxy is a drug that can negatively affect T.

So I apologize, I'm honestly in a depression/panic rut today. What exactly did they say to you on your call with MT? What was their take on it? From what it sounds like based on their response, it's like they aren't offering any early access to anyone until further notice? So why even have a page about it and say that they do?!

There's absolutely no need to apologise, Erika. The things you've experienced so far, and now with the tick bite, would bring many people to their knees. But I've seen that you're a fighter and I'm certain that you'll get out of this mess. Have you discussed with your doctor if there are non-ototoxic alternatives to Doxycycline?

Well, MT's take is that they don't have enough information about Biohaven and BHV-7000, but that they are open to mediate/apply for EA if you have a doctor who is willing to perform this treatment (great that you've found a caring doctor in that case!). They can act on your behalf If your doctor agrees with this plan.

Thanks for the feedback, @Christiaan .. unfortunately it sounds like Biohaven isn't offering any early access at this point to anyone based on what has been shared in the thread, so I am not sure who route would even be worth trying at this point when the answer is ultimately no.

So far I am doing okay on the Doxy, fingers crossed it stays that way and the tick results come back negative this week and I can stop the Doxy.

Great to hear that you're doing ok. Maybe it's an idea to combine Doxy with strong anti-inflammatory supplements to lower chances of ototoxicity? NAD+, Magnesium L-Threonate and NAC might help.