AcelRx Pharmaceuticals, Inc. (ACRX)
Cowen and Company 33rd Annual Health Care Conference Call
March 6, 2013 9:20 am ET
Richard King - President & CEO
Jim Lee - Cowen and Company
Jim Lee - Cowen and Company
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As a reminder there is a breakout session after the talk in Brandeis, which is on this floor. So, without further delay welcome.
Thank you, Jim. Good morning everybody and thank you for staying what promises to be today may be a little bit of gentle storm, but may be a bit more tomorrow.
So first off, we would like to Jim for and to Cowen for inviting us to present at the health care conference. We'd also like to point you at our forward-looking statements information and to guide you that further information on cautionary notes related to investments in AcelRx can be found on our filings with the SEC and you should refer to those.
So, as Jim said, our focus is very much in the arena of acute pain management, with our lead program it's very much focused on the post-surgical arena. Fundamentally, we are trying to change the treatment paradigm for patients in the postoperative setting from a current standard of care to a different and new and improved standard of care.
We have to-date reported two Phase 3 pivotal studies or Phase 3 studies, one of those pivotal placebo-controlled study that I'll review results with you on today, and we have a third study, a pivotal placebo-controlled study that we'll report in the second quarter of this year that will ultimately support an NDA filing in the third quarter of 2013.
Our plan and our intent to commercialize this product on sales in the United States and to indentify and consummate a partnership for commercialization outside of the United States, and in addition in the second quarter we will report results from our ARX-04 Phase 2 program. This is a single sufentanil NanoTab program. It's a funded program by the DOD looking to manage the pain of wounded soldiers on the battlefield. So just heads upon that data point as well.
I'm going to spend a majority of my time though focusing in on talking about our Sufentanil NanoTab PCA System or ARX-01 designed to manage moderate severe pain in the hospital setting.
So current standard of care I referred to a couple of times, about 40 years ago we moved to giving patients, intravenous patient-controlled analgesia. This IV have a infusion pump, which the patient controlled that the push of a button to give a milligram of morphine typically as the analgesia for pain management. We've replaced the patient putting the hand up in the air and saying, nurse I'm in pain, can you come and give me something please. It will allow patient's control, which improves satisfaction. But there are challenges with that delivery mode.
Firstly the use of intravenous opioids is problematic from a number of perspectives particularly, the fact that is morphine and hydromorphone, which are the only two opioids, which can really used intravenously. Those tend to leave to sedation, to oxygen desaturation, and to respiratory depression. The fact that its IV is complicated in the hospital environment you can create analgesic gaps. You've a short duration of action of drug and most importantly, patient mobility is restricted. If you want to go to the bathroom, if you want to ambulate the physical therapy, you're taking the IV pump and the saline IV lines with you wherever you go. And it tends to slow down the process of getting the patient up and ambulated and out of the hospital, which of course is the goal of both patients and hospital in this situation.
Finally, the programming of these pumps can induce complexity and can add to the risk of errors in the hospital. And with an opioid, if you get the decimal points in the wrong place, the concentration of the drug when you program it, you can expose the patient to significant harm. Our goal in developing ARX-01 was quite clearly to get a better opioid to avoid an IV routed delivery and to prevent or to avoid having to program, those every device.
The opioid is relatively straight forward. Still Fentanyl for us was a very attractive opioid in this often older and fragile patient population, not the least of which is but it has a very, very high therapeutic index, ratio of lethal dose to effective dose and at 27,000 at the 100 fold higher than Fentanyl and 300 fold higher than Morphine and is a measure of the safety window, the opioid can operate in. It's also extraordinary lipophilic, which present some unique opportunities to deliver this in a non-IV fashion. And in particular, with that high lipophilic drug it has a very, very quick what is called t ½, ke0, that's the time it takes to get from the plasma to the brain to affected side in the brain, which can provide fundamentally really time onset of action for patients as well.