In Challenging Opioid Market, Acura Still Seeks A Partner
This article was originally published in The Pink Sheet Daily
Acura will meet with FDA Dec. 5 to review results of a Phase II study evaluating the nasal abuse potential of its hydrocodone/acetaminophen combination product, made with its Aversion technology. On the OTC side, distribution for its tamper-resistant decongestant Nexafed has picked up momentum.
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Acura Pharmaceuticals’ stock fell 11% May 28 after the company revealed that FDA advised an abuse liability study for its hydrocodone/acetaminophen product would not support an abuse liability claim.
Ohio and West Virginia chain Fruth Pharmacy begins replacing the 30 mg PSE products available in its stores with Acura Pharmaceuticals’ Nexafed product. Meanwhile, DEA says Westport Pharmaceuticals should not make an extraction-proof claim for its Zephrex-D PSE product.
FDA okays the opioid, which contains abuse-resistant components, with labeling about a study that found the drug less likeable than immediate-release oxycodone.