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Acura Pharmaceuticals, Inc. (OTCMKTS:ACUR) Might Be In For A Big Month

Acura Pharmaceuticals, Inc. (OTCMKTS:ACUR) Might Be In For A Big Month
Written by
Chris Sandburg
Published on
June 21, 2017
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Abuse deterrent opioids are a massive opportunity right now in the US. With opioid addiction at epidemic levels, the FDA and other healthcare associated entities are pushing to bring opioids to market that serve as a safer alternative to the currently available assets in the space, and – as expected – a number of companies are working to achieve just that.One of these companies is Acura Pharmaceuticals, Inc. (OTCMKTS:ACUR).Acura has a number of technologies and a couple assets already at market, but the real value of the company going forward is rooted in a technology called LIMITX, and a drug built using said technology, called LTX-04.The company completed a first round of testing last year, and – at outcome, and based on subsequent discussions with the FDA – decided it needed to conduct an additional investigation based on the results of the initial one. If the additional investigation yields positive results, it paves the way for late stage development of the asset in question and the potentially game-changing catalysts that said development brings.This second study initiated mid-May and – as per management communications – should complete (and readout) this month. Anytime now, then, we could see the numbers hit press and the company revalue to the upside on their release.Here’s what we're looking for from this catalyst.Before getting to the data, it's first important to understand the technology that underpins this product. The company takes an already established drug, in this instance, hydromorphone, and combines it with the LIMITX technology. The idea is that the abuse deterrent asset contains a substance that neutralizes stomach acid. If a patient takes a single tablet, not enough of the neutralizing substance is present to impact stomach acidity to any real degree. As the patient takes more, however, the neutralizing substance concentration increases, and the stomach acidity levels are affected. Neutralized stomach acid translates to the inability of the body to break down additional tablets if ingested, and therein lies the abuse deterrence feature.So, the first trial demonstrated that this concept works when a patient takes four, five or six tablets. However, it also demonstrated that – at its current formulation – there wasn't enough active compound in a combination of one or two tablets to provide relief for the patient.Acura went back to the drawing board and reformulated its initial asset to – hopefully – get enough hydromorphone in there to induce clinical benefit on a one or two tablets regimen while maintaining the abuse deterrent property.The study is called AP-LTX-401, and it's healthy subject study that's enrolling (or more accurately has already enrolled) 60 subjects, randomized to active or control arms.The trial is set up so that patients take one tablet and then are split into two cohorts, one of which will take seven tablets and the other of which will take an as yet undisclosed, exploratory amount.The goal is to demonstrate that the reformulation is effective against the above-described endpoint – release active drug fast enough to have an effect, but maintain abuse deterrence when the patient takes numerous tablets.So, more specifically, we want to see high concentrations of active compound (the hydromorphone) in the blood of the patients in the active arm – at least as high as those in control, who will be just taking standard hydromorphone tablets – that then gets reduced (again, comparative to control) when the patient ups the dose.Safety and tolerability shouldn’t really be a problem here because these are healthy subjects and the active compound is already established standard of care. Of course, this doesn’t mean the unexpected can't happen, so we will be looking out for any potential red flags as and when the numbers hit.As mentioned, management has a June release on the data. We'll be keeping a close eye on Acura's feed and we'll update readers with an interpretation of the results when we get them.We will be updating our subscribers as soon as we know more. For the latest updates on ACUR, sign up below!Disclosure: We have no position in ACUR and have not been compensated for this article.

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