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New Pseudoephedrine Drug Could Hop Back Over the Counter


Pharmaceutical Executive

Yesterday Acura Pharmaceuticals launched its new pseudoephedrine-based product Nexafed, an over-the-counter product aimed at deterring abuse of the illicit drug methamphetamine.

Yesterday Acura Pharmaceuticals launched its new pseudoephedrine-based product Nexafed, an over-the-counter product aimed at deterring abuse of the illicit drug methamphetamine. Pseudoephedrine, the decongestant known also as the primary ingredient in the production of methamphetamine, has been subject to a federal statute which keeps medicines with the ingredient behind the counter of all pharmacies in the US, and limits the sale to consumers to less than 9 grams total of the drug per month.

Nexafed uses Acura’s patented Impede technology, a matrix of polymers that gels to block the extraction of pseudoephedrine, thereby disrupting its conversion into methamphetamine. With this technology in place, Acura is pursuing a spot on the consumer side of the counter, where other pseudoephedrine products are not allowed. If successful, the brand could snatch market share from similar products that require a conversation with a pharmacist for access.

The “meth epidemic” in the United States has been a cause for alarm despite the limits placed on the sale of pseudoephedrine. These restrictions have helped to deter large meth lab operations from surviving, but they have also unintentionally lead to the splintering of its production into smaller-scale, home-based labs that result in cruder formations of the illicit drug. The numbers on meth production tell this story: the DEA logged approximately 13,000 lab seizures in the US in 2005, followed by a drop to about 6,000 seizures in 2007, after the ‘Combat Methamphetamine Epidemic Act’ was implemented in 2006. But with last year’s seizures being well over 10,000, it’s clear that Nexafed could provide a crucial move forward in deterring meth abuse.

Acura verified Nexafed in laboratory tests conducted by an independent research organization, which found that pseudoephedrine could not be extracted in two key processes for meth production.. Additionally, the Impede technology reduced the yield of methamphetamine by half via the direct conversion method, also known as the “one-pot” technique more often used in home labs. Nexafed doses contain 30mg of pseudoephedrine, and the product is bioequivalent to other pseudoephedrine brands on the market. With its demonstrated impact in harm reduction, the intention is to move the product out from behind the counter.

According to Robert Jones, President and CEO of Acura, “the law does provide for exemptions for technologies like ours, and we certainly will be exploring what it may take to get an exemption under that statute.”  If the company is successful in gaining such an exemption, deterrence of abuse is only one of the benefits, says Jones. “It’s also an access issue for consumers, as well as a workload issue for pharmacy departments.” The impact of placing pseudoephedrine-containing products out of easy reach to the consumer means they are less likely to purchase them. Instead, consumers may choose a more conveniently shelved, yet significantly less effective product, such as phenylephrine.

With Nexafed entering the market, Acura will target pharmacists in with discussions around the problem of meth abuse. Acura’s hope is that pharmacists will serve as point-of-sale advocates for Nexafed, not only as a convenience, but also as a way to deter the manufacture of methamphetamine. If all goes according to plan, Nexafed, with its price and efficacy on par with Johnson & Johnson’s Sudafed – and its potential to offset the production of one of the most dangerous and damaging illicit drugs – could upend the lucrative pseudoephedrine-based decongestants category.

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