A new weapon in the "war on meth" is coming soon to pharmacies.
It's "meth-proof" pseudoephedrine. Pseudoephedrine is a decongestant used to treat cold and allergy-related symptoms, but it's also the main ingredient in meth.
Experts say it looks and works the exact same as pseudoephedrine products already available, but Nexafed and Zephrex-D have chemicals that make the pseudoephedrine practically impossible to turn into meth. They also say these new forms could finally be the solution to Oklahoma's meth epidemic.
David Starkey dedicates his life to stopping the meth problem, and says meth-proof pseudoephedrine is a "game-changer." "[I'm] excited that it's fully passed DEA testing and you can get no yield of meth from either of these pseudoephedrine products," Starkey said.
Pharmacist Chris Schiller says lately he's had to focus on enforcing strict pseudoephedrine laws instead of helping patients. "We can actually put it back over the counter where we don't have to take an ID from a patient, treat every patient like a criminal that's coming in just because they have a cold or some congestion," Schiller said.
Meth-proof pseudo turns into a thick gel-like goop rather than a crystal-like powder when it's broken down with the solvents used to make meth. That makes it nearly impossible to extract the pure pseudoephedrine. Schiller said people using pseudoephedrine for the right reasons likely won't be able to tell a difference between the regular and the meth-proof versions. "The technology they used in this particular drug they're using in other medications, and as of right now, they work just the same and have the same effect," Schiller said.
He's hoping meth-proof will be the new norm.
"What I'm thinking might happen is pharmacies will choose to carry just those ones, or legislation will pass to where they can only sell that kind." But Starkey worries the drug companies that make regular pseudoephedrine will do all they can to make sure that doesn't happen. "Eighty-five percent of all pseudoephedrine that's sold is going into the meth cook market," he said. That means they make most of their money off people making meth, and Starkey is concerned pharmaceutical companies won't want to burn up their profit.
So, he says it's up to law-abiding citizens to make sure meth-proof pseudoephedrine becomes the only kind of pseudoephedrine. "Since this is so new, most of your pharmacies don't know about it," Starkey said. "Start asking for meth-proof pseudoephedrine."
Nexafed will be available in Oklahoma pharmacies within the next several months. Zephrex-D is already available in Missouri, and will be coming to Oklahoma pharmacies as well in the near future. In 2004, Oklahoma became the first state in the nation to put pseudoephedrine behind the counter, limit the amount people could buy and require ID for purchase. That then became federal law soon after. Oklahoma also has a drug tracking system as well.
Copyright 2012 Cox Television Tulsa, LLC. All rights reserved.
Updated: 3/13 10:16 am
Published:12/13/2012 6:29 pm
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Acura Pharmaceuticals Launches Meth-Resistant Pseudoephedrine, Nexafed
The Palantine, Illinois-based company, Acura Pharmaceuticals, today launched a new nasal decongestant product formulated to prevent its use in the illicit synthesis of methamphetamine.
Nexafed® is Acura’s brand of 30 mg pseudoephedrine hydrochloride tablets formulated with several inert polymers. This combination is designed to still be effective as a decongestant when taken orally, but the polymers (called IMPEDE™) will form a gummy gel if mixed with solvents commonly used in illicit methamphetamine synthesis. While not necessary for US Food and Drug Administration approval, Acura released information last month on a Phase I pharmacokinetic trial in 30 healthy volunteers that demonstrated Nexafed’s bioequivalence of a typical 60 mg dose to that of “the national leading brand product” (Sudafed®).
Acura’s been working on this formulation for four years as part of an overall, 10-year program to establish specialty expertise in the field of abuse- or misuse-deterrent pharmaceuticals. The company’s first foray into the area was with a polyethylene oxide formulation of the opioid analgesic, oxycodone, to create a product called Oxecta®.
The deterrent approach with Oxecta (using AVERSION™ technology) was two-fold, to impede both intravenous and intranasal misuse of the drug. If solubilized by typical means for injection, the opioid would also form a gelatinous goop that could not be easily handled. For users who might crush the tablet to snort, the formulation contains sodium lauryl sulfate (sodium dodecyl sulfate, or SDS, to my laboratory brethren). This ionic detergent is a strong irritant if snorted but is inconsequential when the drug is taken orally.
(As an undergraduate lab intern, I remember weighing out SDS without wearing a requisite N95 mask. Inhaling the flakes from just the amount of powder poofing up as I weighed it out was irritating enough to my nose and lungs that I never forgot to wear a mask again).
Other abuse-deterrent drug formulations
Acura had been riding high with Oxecta since July, 2011, when it received a $20 million milestone payment (PDF) from Pfizer, the company’s development and sales partner.
However, Acura’s President and CEO Bob Jones told me last Friday that Pfizer had not been as enthusiastic as anticipated about the product and other opioids being developed with AVERSION technology. The product had been priced much higher than the corresponding Roxicodone and Pfizer was still negotiating with FDA over the wording of the physician promotional materials over a year after its FDA approval.
In July, Acura announced early termination of the agreement with Pfizer on three other opioid/opioid plus acetaminophen products with AVERSION technology. Pfizer still retains Oxecta.
Jones told me that he anticipates the launch of Nexafed to go more smoothly because Acura has priced it equivalent to the brand-name pseudoephedrine product and will market it directly to independent community pharmacies as these stores have far more control over shelf space than the large chain drugstores. Moreover, pharmacies that carry only Nexafed might be less likely to be targeted for meth-driven robberies like this one that occurred in Missouri over the Thanksgiving holiday.
“We’re not going to make abuse go away,” Jones says, “but this will go a long way [in minimizing illicit drugs on the street].”
While the Nexafed formulation renders methamphetamine synthesis all but impossible by conventional methods, it would only impede production by the crude, one-pot method by about 50%.
The formulation will also have no effect on the progression of Season 5 of Breaking Bad: the AMC show’s protagonists bypass the need for pseudoephedrine by synthesizing meth from phenylacetone and methylamine, industrial chemicals that are much more highly controlled than pseudoephedrine.
I don’t know about you but I often feel discomforted when I have to buy pseudoephedrine at the pharmacy, showing my license to ensure that I’m not a meth cook. I can definitely see a consumer advantage when buying something like Nexafed — it says, “I’m not a meth cook — I really, really need it for my sinuses.”
Jones hopes that a major selling point by pharmacists will be that the customer buying Nexafed will be helping the community by minimizing the ease with which meth labs operate and helping law enforcement. I’m not sure how far the customer altruism will help sales but I suspect it will be of value in areas where the abundance of meth labs affect crime rates.
One of those states, Kentucky, is a living laboratory where researchers recently reported in JAMA on a trend between legal methamphetamine sales and illicit meth lab seizures. In discussing this paper in October, I expressed my concerns that any resulting efforts to make pseudoephedrine a prescription product would further restrict one of the remaining useful decongestants from legitimate sale to consumers.
Indeed, Jones agreed that Acura feels that a progressive drive to reclassify pseudoephedrine to prescription status is ongoing in the US. He’s hopeful that Nexafed would retain its over-the-counter status because of its abuse-deterrent formulation.
Jones took over leadership of Acura following the untimely death of previous CEO, Andrew Reddick, in early 2011. He notes a sense of personal satisfaction in being involved in cultivating Acura’s portfolio having worked on opioid analgesics early in his career followed by a 11-year stint at Burroughs-Wellcome during the time that Sudafed brand of pseudoephedrine was developed.
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"Meth-proof" pseudoephedrine hitting market soon