Question-and-Answer Session
Operator
(Operator Instructions). We’ll take our first question from Gary Nachman - Leerink Swann.
Gary Nachman - Leerink Swann
First question on the Ereska data; Marty, what did you mean that the outcome could change in the future after you examine all aspects of the data, that maybe you could achieve statistical significance in certain subgroups; could you elaborate on that?
Martin J. Driscoll
These are the initial results. Obviously, with a P-value so close to statistical significance, I think, it’s incumbent upon me and this organization to examine all aspects of the trial. We’ve begun to do that, we’ll look at everything, and I just think that it’s appropriate to state that the future outcome could change or could not change.
Gary Nachman - Leerink Swann
Dan, could just elaborate a little bit more on the intra-subject variability, you know the patient population that was included and how that may have contributed to that.
Dr. Daniel B. Carr
I just wanted to reiterate that these are initial results and we’re in the process of examining all the aspects of the trial including the very one that you bring up so that in the future we can present full results in the appropriate forums.
Gary Nachman - Leerink Swann
How long will the process be for evaluating all the data you think; I guess we’ll have an update on that?
Martin J. Driscoll
Gary, I think, I’ve always been straight up with you and with everyone else; we’ll take the necessary time to examine all of this. With the P-value so close to borderline we want to make sure we do all the proper work.
Gary Nachman - Leerink Swann
Just switching gears; how do you think Cumberland’s IV ibuprofen will compete with your Dyloject, and I guess just having another injectable NSAID out there before you guys, how are your chances in terms of formulary acceptance?
Martin J. Driscoll
Certainly we think the approval of the IV ibuprofen is very positive for Dyloject. First, let me state that it demonstrates further the divisions interest in injectable NSAIDs, and if you look at the comments attributed to the FDA with the approval of the product, we think that it boards well for the continued review and development of IV NSAIDs like Dyloject. Secondly, very importantly, Dyloject is quite distinguished from IV ibuprofen. We have two successful pivotal efficacy trials with P-values of 0.0001. If you look at the IV ibuprofen product, they had three pivotal trials, two in pain and one in fever, and one of the pain trails failed and did not reach statistical significance, and the other trial only achieved significance when used in combination with opiates. In addition to that, their label specifically states that it is only indicated for mild to moderate. Finally, their own data reveals that the relative opiates sparing effect of the IV ibuprofen is only 9%, and as Dr. Carr always tells me, that does not rise to the level of clinical significance. So, I think at the end of the day, it’s important to us because it heightens the interest in IV NSAIDs in the marketplace, both in the regulatory authorities in the market, but I think IV ibuprofen like IV acetaminophen because of its relative weak analgesic effects will be utilized in mild to the lower moderate pain whereas our indication will be in moderate to severe pain as we’ve always indicated, and we think that the market will quickly realize the relative opiates sparing benefits of Dyloject as evidenced in our pivotal trials and we’ll be an important entry for the multi-modal therapy. Finally Gary, I would point out that IV ibuprofen must be infused, I believe, over a 30- to 40-minute period, and as you know, Dyloject is a rapid-acting bolus injection, which we think is a very important distinction for the continued growth in the outpatient or day surgery setting where they need rapid-acting potent IV NSAIDs versus something that has to be infused that has a mild analgesic effect.
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