"We consider the exemption process still an open effort," Dolan says. "We are working with the DEA to try and understand their findings."
She notes that Westport has not actually seen the DEA's test results -- and has put in a formal request for the data.
A DEA spokesman earlier this week declined to comment to Daily RFT beyond the letter.
Westport will continue to do everything it can to move forward with Zephrex-D, Dolan says, adding, "It's really in their best interest.... The resources that go into fighting this ill are tremendous."
Here's the full news release from Westport Pharmaceuticals followed by the DEA letter.
Zephrex-D® - A NEW APPROACH TO FIGHTING ILLICIT METH LABS
St. Louis, MO - May 29, 2013 - Westport Pharmaceuticals, a St. Louis-based, specialty pharmaceutical company focused on OTC consumer healthcare products with abuse deterrent technology, announced today their findings from independent testing of their meth-resistant pseudoephedrine product, Zephrex-D®. This formulation of pseudoephedrine provides a major advancement in the scientific community's ability to effectively "lock" this precursor, therefore, making it impractical and nearly impossible to illicitly manufacture methamphetamine with Zephrex-D.
According to the January 2013 General Accounting Office (GAO) Report, more than 87 percent of domestic meth labs utilize the One Pot meth-making method. Testing demonstrates that meth cannot be produced from Zephrex-D using this highly popular and dangerous One Pot method. Other, more traditional meth-making methods, which utilize an extraction to conversion two-step process, have proven to be impractical using Zephrex-D. In recent independent laboratory tests of Zephrex-D, traditional extraction/conversion manufacturing methods converted less than one half of one percent (0.5%) of the pseudoephedrine into meth. When more advanced analytical conversion methods were applied to Zephrex-D, the yield was less than 2.0%. And, the small amount of meth produced is still locked in excipients that cannot be smoked, injected or snorted.
By way of example, given the Zephrex-D formulation and assuming a standard meth dose of 250 milligrams, meth makers using traditional extraction/conversion methods would have to buy almost 1800 30mg pills to convert enough pseudoephedrine into one dose of meth, coming at a cost of over $450 for the Zephrex-D alone. Additionally, high manufacturing cycle time and other supply costs associated with this process make it economically infeasible. This figure is in comparison to a traditional pseudoephedrine product where only about 11 30mg tablets are needed to manufacture one dose of meth ($2.31 approximate cost). Meth sells on the street for about $30 per 250mg dose.
Westport Pharmaceuticals is confident that Zephrex-D marks a significant step towards improving the security and delivery of pseudoephedrine. This product delivers a practical assault on the fight to end domestic meth manufacture. Federal, state and local law and drug enforcement officials have openly shared their support for this newly formulated product, as it provides great promise to help with this ongoing challenge. Furthermore, delivering pseudoephedrine in this meth-resistant formulation disrupts the illicit meth-making process without further encumbering access for those consumers seeking therapeutic relief from sinus congestion and pressure. It is a win for patients, our communities and all those who are dedicated to protecting and making our neighborhoods a safe place to live.
For more information, please visit www.Zephrex-D.com.