Acura slumps 32% after FDA panel fails to back its pain drug Acurox; decision casts doubts over other niacin agents, says Datamonitor

USA-based Acura Pharmaceuticals saw its share price plummet 32% to %4.01 last Friday, after a Food and Drug Administration panel voted not to recommend approval of Acurox (oxycodone and naicin) until the company submits more evidence to support the drug, which is being co-developed by fellow US firm King Pharmaceuticals under an agreement signed in late 2007. Niacin is known to cause flushing when taken in higher doses, while oxycodone is viewed as highly addictive.

Reviewing the situation, market research firm Datamonitor said that, although the FDA is not bound by the recommendations of its advisory committees, it generally does, and believes that subsequent approval of the drug is now unlikely. Based on acceptance of Acurox for priority review by the FDA, Datamonitor had previously expected that a US launch could take place as early as late fourth-quarter 2009. Had the FDA approved Acurox, the majority of Acurox sales revenue would have been generated from patients switched from oxycodone instant-release. Datamonitor previously expected Acurox to achieve US-specific sales of around $259 million by the end of 2018.

Moreover, with Acurox representing Acura's lead pipeline candidate, subsequent non-approval would represent a substantial blow to the company. Also, given that the FDA's advisory panel called into question that niacin-induced flushing could potentially reduce misuse of Acurox, this casts a shadow over the future development of Acura/King's Acuracet (oxycodone/niacin/APAP) and Vycavert (hydrocodone/niacin/APAP); two early stage pipeline opioids which are designed to deter common methods of misuse and abuse and both contain niacin.