Jonathan Javitt: When this began, it began because people were using ketamine to treat acutely depressed patients. And everybody saw that ketamine wears off after a couple days to a week. And a lot of people thought that repeat use of ketamine wasn’t a great idea. So, people suggested perhaps we develop NRX-101 as a maintenance therapy to prolong the effect of ketamine. And that’s what we did in the STABIL-B study. We got results that was quite encouraging. As you know, lurasidone was originally approved on a 3.9 point difference between lurasidone and placebo and yet we beat lurasidone, a known good drug by 7.7 points. Pretty impressive effect. Remember, Avelity just got approved on a four point difference between Avelity and placebo and we didn’t go against placebo because it wouldn’t be appropriate to do that in suicidal patients.
We went against the best available standard-of-care drug. So, that’s how we got into this and that’s why we got the Breakthrough Therapy Designation. Along the way, we said, well, what if NRX-101 is actually good enough to be a benefit to patients without prior use of ketamine. And we asked that question just as we were getting back into psychiatry a year ago, where we had just enough of our old Phase 2 material to do a smallish study like this. We said let’s test NRX-101 against lurasidone without prior ketamine and see if there’s a signal, see if it’s not futile. And that’s where we are at this point. And based on having reached that point and based on having now the availability of newly manufactured Phase 3 and potentially commercial scale drugs, we’re enlarging this to a registration study because we now believe that there is a real potential for this home-use oral pill — actually capsule to be effective in its own right, not just as a drug to take after ketamine.
So, that’s how we got to where we are.
Jason Kolbert: Makes perfect sense. And last question and you just kind of touched on it also was Breakthrough Designation. Is that something that you feel you’ve been encouraged to go after?
Jonathan Javitt: Well, we’ve been awarded Breakthrough Therapy Designation for the original indication of NRX-101 to use after ketamine. And that gives us the ability — the important part of Breakthrough Therapy Designation is it gives you a dedicated resource at FDA, a Program Manager who is committed, if at all possible, to helping the drug get through the approval process. So, we have that in place now. And the other key benefit of Breakthrough Therapy Designation is it gives you the right to submit your new drug approval application on a rolling basis. So, we’ve said by the end of the year, we’re going to start submitting. We’re going to submit the manufacturing data, the preclinical data so that the whole file is reviewed by the time we finally have the efficacy data to submit. So, those benefits of Breakthrough Therapy Designation are already in place.
Jason Kolbert: Got you.
Jonathan Javitt: And I mentioned that–
Jason Kolbert: Well, and I understand–
Jonathan Javitt: We may have a conversation with FDA when more data are available about specifically extending the Breakthrough Designation to this use of NRX-101, but I’m not sure that that would really change our path to approval in any meaningful way.
Jason Kolbert: Perfect. Thank you. And that answer actually answers some of my timeline questions. So, really the only — the critical hurdle for you is going to be, if I’m right, is just patient enrollment and then data analysis once you completed treating the last patient, right?
