Acura Pharmaceuticals, a US-based developer of technologies to address medication misuse and abuse, has announced topline clinical study results showing that its Nexafed nasal congestion product is bioequivalent to the leading national brand.
The result is significant for Acura because the company needed to confirm that Nexafed would still be effective for patients while incorporating the Impede technology, which disrupts the process of converting pseudoephedrine, the product’s active ingredient, into the recreational drug methamphetamine.
The results come from a Phase I pharmacokinetic study of Nexafed on 30 healthy adult subjects, to confirm that changes to its formulation to improve manufacturability would still provide effective nasal congestion relief.
Acura Pharmaceuticals president and CEO Bob Jones said Nexafed is on track for a US launch later in 2012.
"It is important that our Impede technology used in Nexafed does not compromise the effectiveness of the active ingredient, and the results of our clinical study demonstrate this," said Jones.
Nexafed is a 30mg immediate-release next-generation pseudoephedrine tablet.
The US Food and Drug Administration approved Oxecta, Pfizer’s drug for the management of acute and chronic moderate to sever pain, which incorporates Aversion, Acura’s other drug safety technology.
Aversion has been developed to discourage the abuse and misuse of pain relief products by incorporating features that deter common methods of pharmaceutical product misuse.