Acura’s blushes cause it to lose adcom backing

It was red faces all round at Acura Pharmaceuticals yesterday after an advisory committee voted almost unanimously not to recommend approval of the group’s lead product Acurox, an instant release, tamper resistant form of oxycodone.

In a damning and decisive looking 19-1 poll, the committee highlighted the fact that the niacin used to deter abuse by producing painful facial flushing if the drug was taken excessively orally, could easily be counteracted by eating food or taking aspirin. The other main concern of the panel was that very sick patients legitimately taking the drug could also experience this painful side effect, even at normal doses.

The news almost certainly means that come its eventual PDUFA date Acurox will be getting another complete response letter in the post. But as seen by last week’s surprise approval of Tarceva in lung cancer as a first-line maintenance therapy, the FDA sometimes, but not often, goes against the recommendations of its advisory committees (OSI wins Tarceva label expansion, but Astellas unmoved, April 19, 2010). However, the very polar view of the panel makes this look unlikely for Acurox.

Big impact

In early morning trade today Acura's shares slumped 37% to $3.73, a four-year low. In total Acura's shares have lost over half their value since negatively received FDA briefing documents were posted on April 20. This is unsurprising given that Acurox is the only product that Acura has in the clinic and as such nearly all of its value was tied up in the product. The setback for Acurox is also likely to impact two other drugs in the group's pipeline, pre-clinical Vycavert and Acuracet, opioids that also contain niacin. 

According to consensus forecasts from EvaluatePharma, Acurox, which is partnered with King Pharmaceuticals, was expected to achieve sales of $138m by 2016. However, any impact to King is likely to be much less severe, but still noticeable. The drug was valued at $185m to King, equal to 7% of its share price - King's shares have dipped 5% since the briefing documents were published. 

In contrast, Acura's shares had actually been on a steady rise until this setback for Acurox. What had given investors hope and sent the shares up was the fact that earlier this month Purdue Pharma had managed to secure approval for its extended release, tamper resistant reformulation of OxyContin, which like Acurox had previously received a complete response letter (Event - Acura and King hoping adcom will end approval pain, April 7, 2010).

Unmet need

But all may not be lost, as the US government and health officials are desperate to find a solution to the growing problem of opioid abuse. Offering a very small glimmer of hope some panel members encouraged Acura to come back with better data for the drug.

However, given the concerns about the niacin component of Acurox, the group may have to consider removing it. That would only leave the drug tamper-proof if it was crushed up and injected, because it turns into a gel when mixed with alcohol or water, although even this marginal improvement was enough to get Purdue’s version approved. 

Acura has vowed to continue to work with the FDA, but if the drug does need to be reformulated approval could be several years away, a wait that investors in Acura may not be prepared to endure and one that the company, with only $33m in cash on the balance sheet, will certainly struggle with.

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