Why AcelRx Pharmaceuticals Shares Spiked Temporarily

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Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of AcelRx Pharmaceuticals (NASDAQ: ACRX  ) , a clinical-stage biopharmaceutical company focused on the treatment of acute pain, soared as much as 32% after the company reported positive top-line data from a late-stage trial. Shares have since given back nearly all of their gains, however, and are up only around 4% as of this writing.

So what: AcelRx announced before the opening bell that its pain management system, Sufentanil NanoTab PCA System, met its primary endpoint in a late-stage study of providing a greater reduction in post-operative pain as compared to the placebo. This study reconfirmed all of AcelRx's previously announced late-stage studies on its pain management system, and the company is on pace to file a new drug application by the third-quarter.

Now what: It's certainly a positive day for AcelRx shareholders, but I'm not nearly as excited about today's data. I'm not disputing that AcelRx's drug delivery system met its primary endpoint. Instead, I'm concerned about another opioid substance going before the Food and Drug Administration. Opioid substances don't have a particularly good track record of approval with the FDA, and AcelRx has already had a huge run higher in anticipation of today's data release. There's only so much blood you can squeeze out of a turnip, and I foresee considerably more chance of downside than upside at current levels.

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  • Report this Comment On May 21, 2013, at 6:07 PM, jdlazar wrote:

    i don't think you understand either the FDA issues or the intended use of the AcelRx drug-device combination.

    FDA is concerned about opioid abuse/dependence.

    The AcelRx drug-device is designed for use in hospital by nurses.

    I have no stock in this company.

  • Report this Comment On May 22, 2013, at 7:22 AM, tvmanjon wrote:

    This is hardly a scientific response. It has no supported information. It only states the authors opinion based on what?The Opioid addiction is a major problem in this country but the FDA isnt going to solve it by denying a NDA based soley on the type of drug used are they? This device and drug solve a number of issues never addressed before.1. Thecumbersom use of a IV bag filled with morphine that causes oxygen depletion espically in the eldery and obese. 2. Faster uptake time 3. Favored by the patients and medical staff who have used this device?drug for post-op acute pain control during the first 24-72 hours after surgery 4. No risk of infection. 5.It will be administered in a hospital with strict controls. The REMS will address that. As far as value that is something that will be determined by investors. Its a new approach to a old problen that has much merit.

  • Report this Comment On May 24, 2013, at 5:15 AM, scott0807 wrote:

    it's not a new drug, it is the delivery system that is novel. buy, buy now, buy often.

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