Kumar Budur: No. I think that you covered everything. Thank you.
Jeffrey Dayno: Okay.
Charles Duncan: Okay. And then, as a follow-up, I guess you probably can’t provide any information on the persistence within that IH open-label extension. But I guess I’m wondering, if you think about the mechanism and utility in IH, how would you think that compares to, say, narcolepsy and the potential for persistence being greater in IH than even it is in narcolepsy? Thanks.
Kumar Budur: Good morning, Charles. Thanks for that question. But narcolepsy and idiopathic hypersomnia, both of them are central disorders of hypersomnolence, and there is data — strong data to suggest maintenance of effect in patients with narcolepsy based on all the clinical trials that we have done thus far. Specifically, with the INTUNE study, in the open-label part of this study, we saw a robust clinical impact. I mean, eight to nine patients who completed the eight-week open-label treatment period were respondent based on ESS of greater than or equal to three criteria, which is much more stringent than the criteria from the American Academy of Sleep Medicine. And also, we saw a huge magnitude of response, 9.4 point drop from baseline to the end of the eight-week open-label treatment period.
And to your question about the long-term extension study, as Jeff alluded to earlier, almost 90% of the patients elected to participate in that study, and we continue to collect the data on the safety and the efficacy parameters. We don’t have those data yet, and we are planning to have our data cut sometime toward the end of November, where we will start seeing the safety and efficacy data from the long-term extension study as well.
Charles Duncan: And can we assume that meeting happens in, say, possibly the first quarter? Obviously, it depends, not only on your schedule, but is that kind of the target?
Kumar Budur: Good question, Charles. Right now, we are focused on a thorough review of the data which will inform the strategy when we meet the FDA. Right now, we are planning to complete all the assessment and analysis by the end of November. And immediately after that, we will start working on the meeting request, briefing document, and request a meeting with the FDA in early first quarter of 2024.
Jeffrey Dayno: Yeah, Charles. I would just add, so yeah, so we’re moving sort of expeditiously. This is obviously a high priority for us, so we’re moving quickly to review all the data, put in the meeting request, and get in front of the agency to have this discussion as we actively pursue the indication for pitolisant in IH.
Charles Duncan: Thanks.
Operator: Thank you. We’ll take our next question from Danielle Brill with Raymond James. Please go ahead.
Unidentified Participant: Hi. This is Daniel Nee filling in for Danielle. Congrats on the strong quarter. We have a question on — if there’s new updates on the citizen petition. And the second question on that, we see that there is no reporting of patients on Wakix exiting this quarter, and there’s only average patients reporting. And is this the new convention for the future earning as well. Thank you very much.
Jeffrey Dayno: Sure. Thanks for your question. Jeff, why don’t — in terms of exiting number of patients, do you want to just address that first? And then I’ll speak to the citizens petition.
Jeffrey Dierks: Sure. So I mean, the existing number of patients for this quarter was approximately 5,900 patients. We disclosed exiting patients in the previous two quarters to really hate — help to frame the dynamics in those quarters. You tend to see the typical payer seasonality in Q1. And obviously, we had an inventory dynamic in Q2. But we’ve always historically reported average number of patients because we believe that average number of patients on Wakix is the best metric to assess the continued growth and uptake of the brand, given that it takes into account new patient starts, continuing patients, and all the patient medication behavior, compliance, persistency, discontinuation rate. And I think that what we’re seeing in that strong growth in average number of patients demonstrates, not only the strong interest in the narcolepsy community, but really highlights that large remaining diagnosed patient opportunity that we continue to tap into as the market allows.
Jeffrey Dayno: Okay. Thanks, Jeff. And as far as — let me come back to your question on the citizens petition and just an update on that. So as you may recall, the FDA issued a response to the citizens petition in September to meet its statutory requirement of 180-day response. And at that time, it said it needed more time to review the CP. So this is a standard response that the FDA uses in more than 50% of the cases, and it’s what we anticipated. So while we first wanted to wait to give the agency a chance to conduct its review, now that there’s no defined time line for the FDA to respond, we’re taking action to try and get the FDA to issue a final response in a timely manner. We’re evaluating those options in regards to how to best assist and work with the agency in issuing a final response.
It’s our position that Wakix is the only nonscheduled treatment option approved for adult patients with narcolepsy that it would be a disservice for patients and healthcare professionals to continue to be sort of impacted by the unfounded allegations in the citizens petition regarding the safety and efficacy of Wakix which could possibly kind of impact the treatment decisions. So we affirm the regulatory validity of the Wakix NDA. We remain confident in the overall risk/benefit profile of Wakix and based on the robust clinical development program and the post-marketing safety data that we submit to the FDA on a regular basis and the FDA reviews. So to date, the agency has not contacted us regarding the citizens petition. But as we go forward, we will work with the agency and welcome their close attention and review because we’re confident that once they review the unfounded allegations in light of all the information available to them, it’s our position that they will ultimately deny the petition based on its lack of merit.
