I feel like the biggest barrier to break will be the simple fact that they have not formally discussed BHV-7000 for tinnitus, let alone put together a trial.
That's a great idea @ErikaS . Despite that most Kv7 research is done in animal studies, these articles do make a strong (theoretical) case that the altered state of potassium channels in fusiform cells play a crucial role in the manifestation of tinnitus. Maybe this will convince Biohaven to help us out
When you look at Biohavens points for expanded access consideration, the one states " There is preliminary clinical evidence of effectiveness and acceptable safety of the investigational treatment for that condition"..
Definition of preliminary clinical evidence is "indicates that the drug has the potential to address unmet medical needs for such a disease or condition."
We have the research evidence
/articles by Prof. T and others that prove dysfunction/change in KV7.2.3 is essetinal to onset of T. I have at least 3 articles claiming that and suggesting that a KV7 modulator could be the key in tinnitus treatment. Then the rat study with Retigabine.. Also 2019 article of Dr Shore hitting on the significance of KV7 dysfunction in tinnitus. The evidence is there, in my opinion!!
A major article to include is "Transient Delivery of a KCNQ2/3-Specific Channel Activator 1 week after Noise Trauma Mitigates Noise Imduced Tinnitus" by Thanos et. Al. If that isn't strong preliminary clinical evidence with the other articles, I don't know what is.