Zephrex-D Solo Show In W.Va. Could Move Tamper-Resistant PSE To Starring Role

With CVS selling only Zephrex-D at its W.Va. stores, Walgreens planning to make a similar change and pseudoephedrine diversion to make meth also a problem in other states, other manufacturers of single-ingredient PSE products could feel pressure to start using tamper-resistant formulations.

[Westport Pharmaceuticals LLC]’s Zephrex-D tamper-resistant nasal decongestant perhaps has the next best thing to front-of-counter placement at CVS stores in and near West Virginia – it is the only single-ingredient pseudoephedrine product available.

With national retail chain Walgreens planning to make a similar change in its West Virginia stores and with PSE diversion for making methamphetamine also a problem in other states, other manufacturers of nonprescription, single-ingredient PSE products could feel pressure to start using tamper-resistant formulations.

Additionally, state pharmacy boards could get behind requiring that all nonprescription PSE products have tamper-resistant formulation, while remaining available behind-the-counter only, as an alternative to requiring prescriptions for all PSE products.

CVS Caremark on June 20 removed other single-ingredient PSE brands and began offering only Zephrex-D (30 mg, immediate release) in more than 90 CVS stores in West Virginia and within 15 miles of the state’s border in Kentucky, Maryland, Ohio, Pennsylvania and Virginia.

The Woonsocket, R.I.-based firm said it made the change to help curb the diversion of PSE from nonprescription drugs to use for making methamphetamine, a widespread problem in West Virginia.

“By replacing the single ingredient products that are preferred in the making of meth with a tamper-resistant version in these stores, our customers continue to have access to a single ingredient PSE product for legitimate purposes,” Mike DeAngelis, CVS’ public relations director, said in an email.

Deerfield, Ill.-based Walgreen Co. also is planning to also stock only tamper-resistant single-ingredient PSE products in its West Virginia stores.

“We have agreed to adopt best practices in West Virginia and are still working out the details,” a spokesman said. But the firm has not decided about stocking only Zephrex-D as a single-ingredient PSE product, or also offering Nexafed, Acura Pharmaceuticals Inc. ’s product also formulated to be tamper-resistant.

Tamper-Resistant Competition

St. Louis-based Westport conferred with CVS executives about making the change and had enough Zephrex-D available to supply the chain’s stores as the only single-ingredient PSE being sold, VP and General Manager Paul Hemings said.

Acura also is the only supplier of a single-ingredient PSE product for a West Virginia drug store chain. Fruth Pharmacies in 2013 began exclusively stocking Nexafed (30 mg, immediate release) in all of its stores, primarily in West Virginia and some in Ohio (Also see "Tamper-Resistant Pseudoephedrine Sparks Pharmacies’ Interest" - Pink Sheet, 10 Jun, 2013.).

“The CVS decision to stock only meth-resistant single ingredient pseudoephedrine products in their West Virginia stores now means a vast majority, if not all, of chain and independent pharmacies in that state have taken a proactive stance against methamphetamine production,” Peter Clemens, Acura’s senior VP and chief financial officer, said in a statement.

“As more states take a proactive role in supporting meth-resistant technologies, we expect other chain pharmacies to also expand their programs as well,” Clemens said, adding that Palatine, Ill.-based Acura continues to work with CVS about offering Nexafed in its stores.

However, CVS’ choice of stocking only Zephrex-D could have been influenced by research noted in Westport’s marketing materials (Also see "PSE Product Makes “Highly” Tamper-Resistant Claim With 100% Out Of Reach" - Pink Sheet, 20 Jun, 2014.).

Westport cites research by Analytical Bio-Chemistry Labs, of Columbia, Mo., showing that less than 2% of the PSE in a single dose of Zephrex-D can be extracted in the two-step method some meth cooks use and research by multiple law enforcement agencies showing that none of the ingredient can be removed in the one-step method, which is used more often because it requires less equipment and time.

Conversely, more than 70% of the ingredient can be removed, using either method, from traditional formulations of 30 mg, immediate-release PSE products.

Westport’s marketing materials also state that Analytical Bio-Chemistry Labs data show more than 20% of the PSE can be removed with the two-step method from Nexafed. An Acura-funded study showed 49% can be extracted in the one-step method, according to Westport’s marketing materials.

The Acura study was published in September 2013 in the American Journal of Drug and Alcohol Abuse. It showed “no pseudoephedrine could be extracted” from Nexafed in the two-step method, the firm said.

Limiting Brands Hurts Consumers

The Combat Methamphetamine Act allows the Drug Enforcement Administration to grant front-of-counter waivers to nonprescription PSE products that are determined to be extraction-proof.

However, Westport does not expect DEA will be convinced that any PSE formulation clears the extraction-proof threshold to be available front-of-counter.

And as long as multiple products in the category are available behind-the-counter, Westport expects well-known national brands and lower-priced store brands, none with tamper-deterrent formulations, will be consumers’ first choices.

But as the only single-ingredient PSE product in CVS stores in West Virginia and nearby, Westport expects a sales boost. “It will be exciting to watch how this plays out over the next few months,” Hemings said.

The Consumer Healthcare Products Association acknowledges that retailers can limit the selection of products they offer to help prevent PSE diversion, but the trade group says this approach punishes consumers who have legitimate needs for the products and who prefer to buy certain brands.

“Rather than limiting consumers’ access to their preferred medicines, we believe an effective path forward in West Virginia is passage of a meth offender registry to help block the sale of products containing PSE to known meth criminals,” CHPA said in an email.

Working in conjunction with electronic tracking systems tracking retail PSE purchases, meth offender registries are intended to prevent a person convicted of a meth-related crime from purchasing any medicine containing PSE for certain numbers of years following their convictions.

Michigan lawmakers this year enacted legislation for a meth offender registry and Alabama, Illinois, Kentucky, Oklahoma and Tennessee also have implemented the tool in their efforts to curb PSE diversion.

Michigan and Oklahoma set 10-year and Kentucky set a five-year prohibition for persons convicted of meth-related charges; Alabama and Tennessee set seven-year bans for all drug offenders; and Illinois permanently bans meth offenders from buying nonprescription PSE products, according to CHPA.

In a release, Carlos Gutierrez, CHPA’s senior director of state government affairs, said a meth offender registry “epitomizes” an approach to curbing meth abuse that “is tough on crime without being unnecessarily burdensome on law-abiding citizens.”

Hemings agrees that consumers prefer to have a choice of brands. “Absolutely, it’s a legitimate argument,” he said.

More PSE brands could use the same formulation as Zephrex-D, [Highland Pharmaceuticals LLC]’s Tarex technology, which turns PSE into a gel that will not crystallize, deterring its use in meth making. Hemings said Westport within the past year has talked with several firms about using Tarex.

Acura uses its proprietary Impede formulation for Nexafed and has not shown interest in licensing the technology to other firms. Impede applies a polymer coating that makes separating the PSE from other components of a product more difficult.