x min read

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) Might Be A Buy The Dip Opportunity

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) Might Be A Buy The Dip Opportunity
Written by
Chris Sandburg
Published on
October 13, 2017
Copy URL
Share on LinkedIn
Share on Reddit
Share on Twitter/X
Share on Facebook

AcelRx Pharmaceuticals Inc (NASDAQ:ACRX) is taking a beating in the biotechnology space this week on news that the FDA has issued a Complete Response Letter (CRL) for its lead development asset, DSUVIA. ACRX Daily ChartAs things stand, the company is currently trading for $2.25 a share, down close to 60% on its market capitalization at close on Wednesday. The disappointment is all over the financial news media and it looks as though we are going to see some further weakness as the company heads into the weekend.However, longer-term, we think there may be opportunity here.Here is why.For those new to the drug, it's nothing new in terms of active compound. DSUVIA is sufentanil (a commonly used opioid pain management drug) but repackaged to alter administration and to, in turn, overcome some of the problems currently associated with the standard of care administration routes.In postoperative pain settings, IV administration opioids are king. With sufentanil, however, when administered intravenously, its impact is too short-lived for it to be a really effective pain management tool.With DSUVIA, AcelRx has done two things – first, created a soluble pill form of sufentanil that can be placed under the tongue to dissolve directly into the bloodstream and second, created an applicator device that administers one pill at the time under the tongue of the patient. The NDA for the drug was pretty strong and we actually highlight this one as one to watch on a couple of occasions in the past in anticipation of a clean run to approval.Unfortunately, the FDA didn't see it like that.The agency has two problems with the application. First, that the company hasn't put together enough safety data based on the highest dose of the drug recommended on the label.Second, that there's the potential for pills dropping out of the device or more pills than required being administered (as well as the potential for misuse – sufentanil is a highly abused drug in the US).So, the downside is that the company is going to have to carry out a couple more trials before resubmitting – one safety at the maximum tolerable dose and one to show that human error isn’t an issue. These will cost money and – at this end of the biotechnology space, that can be a major risk for the speculative investor.The upside, however, is that these issues shouldn't be too difficult to resolve.The first one, the safety issue, is 100% resolvable. If the safety study doesn't serve up the data required, just alter the label to lower the maximum dose recommended. Simple.The second is the trickier one but still shouldn't prove too difficult. The FDA often leans towards the side of caution with these things, assuming human stupidity. That's reasonable, but this application is targeting administration in a medically supervised setting. This means that, in all likelihood, it's going to be medical professionals that administer the drug and, if it's not, it's going to be individuals that are being watched by medical professionals to ensure correct application.There is also data already in place that suggests device errors are well below the allowed error threshold put in place by the FDA, so as long as the company can replicate this trial (and there is no immediate reason why it shouldn't be able to do just that) then this second, trickier issue should be 100% resolvable as well.From a timeframe perspective, we're probably looking at 3 to 6 months to get the trials completed and a further six months' review time based on a Class 2 resubmission to the FDA.This suggests that DSUVIA could be approved as early as third quarter 2018, assuming all runs smoothly.Check out our previous coverage of this one here. We will be updating our subscribers as soon as we know more. For the latest updates on ACRX, sign up below!Image courtesy of Tamaki Sono via FlickrDisclosure: We have no position in ACRX and have not been compensated for this article.

Discover Hidden Gems

Don't miss the next big opportunity. Subscribe for timely alerts on potential market movers.