Acura Pharmaceuticals hopes its "extraction-resistant" pseudoephedrine hydrochloride tablet can break free of the pharmacy counter to true OTC status, and help protect the popular decongestant ingredient from becoming prescription-only, a top executive said.

However, the Palatine, Ill., firm faces some hurdles on the path to those goals.

Acura plans to launch by the end of this year a 30-mg PSE tablet employing proprietary Impede technology to prevent separation of PSE from other ingredients and thus thwart diversion of the drug to methamphetamine production, said interim CEO Bob Jones.

Under the proposed brand name Nexafed, pending a trademark application, the product would sell at national and regional retailers for a comparable price to other PSE products, the firm hopes.

Impede is "an addition to the armament of legislative and law enforcement approaches" to fighting meth production. – Acura's Bob Jones

Nexafed's active ingredient is equivalent to Johnson & Johnson's Sudafed.

But Nexafed delivers the PSE with Impede, a combination of "standard-grade, well-known" inactive ingredients and polymers that "form a gel that traps PSE" when the tablets are placed in a solvent in an attempt to extract the meth-precursor ingredient, Jones said.

"The beautiful thing about our technology is it doesn't add substantial production costs," so "we can add benefits without increasing the price to consumers," Jones said.

All ingredients are approved under the cough/cold monograph, so a new drug application is unnecessary – saving the firm time to market and money, he said.

Getting Out From Behind The Counter

Initially Nexafed will be sold behind the counter, where the Federal Combat Methamphetamine Epidemic Act of 2006 banished all PSE products in attempt to curb meth production, Jones said (Also see "Pseudoephedrine Will Be Behind The Counter Across The Country By October" - Pink Sheet, 6 March, 2006.).

However, "our long-term hope is, if we have a substantial impact on the ability to convert PSE to meth, then perhaps we might get an exemption" from the sales restrictions created by Combat Meth, he said.

Such a move, if successful, would give Acura's product a substantial competitive edge over other PSE products, which consumers currently must obtain from a pharmacist after showing identification and signing a log. It also would bypass sales restrictions on the quantity consumers could buy, said John Gilbert with the Washington-based law firm Hyman, Phelps & McNamara.

The Regulatory Hoops

Gilbert noted provisions in Combat Meth and Drug Enforcement Administration regulations allow firms to petition DEA for exemption of a PSE product from the sales restrictions.

The provisions require firms to prove the product could not be used or diverted for an illicit use such as meth production. This likely would include submitting studies the firm conducted to establish that extraction of PSE was impossible with known methods or that it is so difficult meth manufacturers could not do it, Gilbert said.

Jones said Acura's studies found Impede blocks 100% of PSE extraction by the three most common methods.

Jones maintains the technology blocks the newest extraction methods and "just about every solvent we could think they would try."

According to studies the firm conducted, these same methods allow meth cooks to extract 96%, 89% and 79% of PSE from Sudafed tablets without Impede technology.

Impede is "an addition to the armament of legislative and law enforcement approaches" to fighting meth production while also protecting easy access to PSE by consumers who legitimately need the drug, Jones said.

The exemption provisions also require a firm to provide its full name and address, the trade name of the scheduled chemical for which exemption is sought, other facts that support the exemption, and certification that the product can be sold lawfully under the Federal Food, Drug and Cosmetic Act, according to the DEA regulation.

A firm also must identify trade secret and confidential information for protection and any other key information the company deems applicable.

Acura also might need to apply for exemptions from some state laws, Gilbert added. Some states have slightly different restrictions, such as on the maximum amount of PSE that can be purchased at once, or the type of log and tracking system consumers must sign. Those states might recognize a federal exemption or require a separate petition.

A Long Row To Hoe

The exemption process "could take awhile," and if too many states require second petitions, it might be too cumbersome to be worth it to the firm, Gilbert added.

Jones acknowledges it is a "long-term process," but believes the company has a strong case. He says that in addition to anti-extraction study data, Acura plans to support its petition to exempt Impede PSE with data on which PSE products law enforcement finds at meth labs during seizures, Jones said.

"As time goes on and these lab seizures take place and law enforcement finds our products are not being confiscated in the seizures, that would be a tell-tale sign that our products are not being used to make meth," he said.

Stopping the wide range of existing PSE products "would be untenable to the manufacturers of those products and their consumers." – Joseph McGovern, The Atlantis Group

For this strategy to work though, the firm "would have to build sales to represent a significant portion of the PSE business for no seizures in meth labs to be important," notes Joseph McGovern, a consultant with The Atlantis Group.

Building sufficient market share could be a sizeable hurdle because consumers "will need a reason to purchase this new 'abuse deterrent' PSE since if the consumer, like most consumers, intends to use the product as directed there is no reason to change from their existing PSE product."

Sales also might suffer because of "the very publicity that this product cannot be abused for meth uses," he said.

Meth-Resistant Is The New Green

Acura plans to overcome competitors with strong heritage in the crowded decongestant category by pitching its Impede PSE product as a unique way to support communities.

"Meth is a localized issue that is extremely costly in terms of cleanup and devastating on individuals. We hope that retail chains and mom-and-pops would embrace [Nexafed] as a safer way to sell pseudoephedrine and support their community," Jones explained.

Acura will pitch the product similarly to consumers, emphasizing the possibility of "putting meth producers out of business," and protecting OTC access to the decongestant, he added.

While this strategy may seem dubious, consumer willingness to seek out and pay more for "green" products demonstrates the significant potential of marketing a product as a responsible alternative to the status quo (Also see "Going Green Can Boost Sales And Profits, But Targets Elusive Consumers" - Pink Sheet, 25 May, 2009.).

The firm also plans to push retailers to drop PSE products that do not contain technology like Impede, Jones said. Otherwise, meth producers will remain in business by buying non-Impede PSE products, he said.

There are many challenges to convincing retailers to stop selling non-abuse-deterrent PSE products, McGovern said.

"There is a very wide range of PSE products, brands and low-price generics, various dose forms, long-acting and short-acting products, combinations with antihistamines and analgesics," he said. "Stopping their sale would be untenable to the manufacturers of those products and their consumers," he said.

Incorporating abuse-deterrent technology into these products would be complex and costly, but manufacturers might be interested if they believe it could increase consumer access to PSE and bring their products out from behind the counter.

Impeding A Full Line-Up

While Acura's technology could become a hot commodity for licensing to different firms, the firm plans to use Impede itself and roll out a wide range of finished PSE products, which would address some of the hurdles McGovern outlined.

"To the extent we are successful," with this first product, "meth converters will move on to the next easiest product – likely extended-release or combination products. So, our ultimate goal to really thwart these guys is to develop a full line of PSE-containing products," Jones said.

The firm likely will begin with extended-release PSE, but has no timeline. "Our focus really has been on getting the technology out in the marketplace," Jones noted.

Reversing The Reverse Switch

Even if Nexafed remains behind the counter, the firm hopes Impede can slow or stop the growing trend of local legislators seeking to require prescriptions for the decongestant.

Oregon, Mississippi and local jurisdictions in Missouri already require prescriptions for PSE, and more states are considering similar legislation (Also see "State Pseudoephedrine Legislation" - Pink Sheet, 25 April, 2011.).

Legislators adopted the extreme measure because meth cooks adapted their purchasing techniques to work around Combat Meth Act restrictions.

For example, meth producers now can make meth with only 100 tablets of PSE, Jones said. Before, the recipes called for thousands of tablets.

As a result, small-scale meth production labs began to increase. Meth incidents, which dropped nearly two-thirds from 18,581 in 2004 to 6,233 in 2007 after PSE products first were moved behind the counter, also are climbing – increasing 62% to 10,064 in 2009 from the low in 2007, according to DEA.

Jones maintains widespread use of technology like Impede can stop even small production meth labs and make prescription laws unnecessary.

By Elizabeth Crawford

Acura's Meth-Impeding Nexafed Pseudoephedrine Could Transform Category

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