67 WALL STREET, New York - August 16, 2013 - The Wall Street Transcript has just published its Medical Research, Diagnostic Substances and Life Science Tools Report offering a timely review of the sector to serious investors and industry executives. This special feature contains expert industry commentary through in-depth interviews with public company CEOs and Equity Analysts. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Health Care Consolidation Activity - Cost Reduction and Improving Efficiencies - Cost Reduction Amid Reimbursement Uncertainty - Health Care Growth Sectors Identified
Companies include: AcelRx Pharmaceuticals, Inc. (ACRX) and many more.
In the following excerpt from the Medical Research, Diagnostic Substances and Life Science Tools Report, the Director, President and CEO of AcelRx Pharmaceuticals, Inc. (ACRX) discusses company strategy and the outlook for this vital industry:
TWST: Would you elaborate on Zalviso, your lead product candidate? How far advanced are you in terms of releasing this product?
Mr. King: We've completed all of our late stage clinical tests, including two placebo-controlled studies and one active comparative study against intravenous patient-controlled analgesia with morphine; all very successful studies, clearly demonstrating that our new technology, Zalviso, has an ability to manage postoperative pain well while also giving both patients and health care professionals a good experience in that management process.
We are now in the middle of putting together our New Drug Application, our NDA, to submit to the FDA. That should happen later this quarter. We are also preparing to launch the product in the United States on the back of an FDA approval, which we hope would occur about a year after submitting our NDA. Assuming that the FDA approves Zalviso, we would then look to begin to commercialize in the last quarter of 2014 and into 2015.
TWST: Could you speak to Zalviso's biological role with particular emphasis on how it addresses IV PCA?
Mr. King: As I mentioned earlier, IV PCA is a combination of an infusion pump delivering an opioid, in this case typically morphine or hydromorphone, to a patient. The patient controls the delivery of morphine with a button that they press when they feel the need for pain relief, which is delivered to them via an intravenous line. Our system called Zalviso uses a different opioid called sufentanil. Because sufentanil loves fatty tissues, we can deliver it under the tongue without using an intravenous line.
From under the tongue, sufentanil leaches into the plasma to get delivered to the effector site in the brain where the opioid receptor is located. Because we deliver sufentanil sublingually, we don't get the very sharp high peaks that you see with IV-delivered medication. You also don't need an IV line obviously; it's just going under the tongue, so it can easily be placed there. But to help in that placement, we have developed a...
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