An end to opioid overdoses, addiction?

http://www.dailyrecord.com/story/news/2017/01/29/end-opioid-overdoses-addiction/97003094/

How naive .. that there are no addicts out there with a degree in chemistry that could figure out how to circumvent the abuse deterrent process… post it on the web or “dark web” and their process as an abuse deterrent – IS TOAST !

A Morristown-based pharmaceutical company hopes a medical breakthrough it patented last month may break the lethal cycle of rising opioid addiction and overdoses, once and for all.

Alitair Pharmaceuticals, Inc., a clinical stage-pharmaceutical company typically focused on respiratory health, announced on Dec. 15 that it had obtained a U.S. patent covering its prescription-drug overdose-reduction technology, trademarked as ODR.

The ODR chemical compound is designed to modulate drug release and reduce the risk of prescription-drug overdose, regardless of how many tablets or capsules are ingested, bonding to the opioid on a molecular level and providing appropriate release of a drug at labeled doses, but limiting release at excessive doses.

“Can you imagine a world where people can take pain-killers without the risk of addiction or overdose?” Howard said. “This is the biggest idea I’ve had in my entire life.”

“This could have a major impact on our opioid-abuse problem, not only here in New Jersey but across the nation,” said Assemblyman Anthony M. Bucco, who recently met with Howard at his legislative office to discuss his discovery.

“Basically, we form a formulation with what are called ion exchange resins,” Howard said. “The way it works is when you swallow the tablet, only hydrochloric acid will make the (ODR) come off this formulation. We found a way, in layman’s explanation, to deplete the hydrochloric acid in your stomach, then no more drug will be released. We have demonstrated in laboratory studies that we can control the release. If you take one tablet, for example, of hydrocodone for pain, you get 100 percent of release. If you take two, you get about 70 percent release from those two tablets. If you take three, you get 50 percent release. Above that level, you will get no additional release from the tablets.”

Following the depletion of hydrochloric acid in the system, the body would need at least an hour or two to replace it, “by which time the drugs will have passed through your stomach,” Howard said.

ODR also would prevent opioid abuse in other forms, such as addicts who grind a pill into powder to snort or liquidity it to inject it for a stronger “rush.”

“You can’t smoke them, you can’t inject them, you can’t snort them up your nose,” he said. “You can’t grind a molecule. The only thing that causes release of the drug is hydrochloric acid. A chemist might be able to figure out a way to eliminate the active drug (in the opioid pill), but it would require a very high level of skill and knowledge. The average abuser probably wouldn’t be able to do that. They’d have to go to college for a coupe of years to take chemistry courses.”

The ODR-opioid combination also would help the elderly or other users who may confuse their dosages and take too much by mistake.

“You don’t have to do anything, you don’t have to know anything, it’s built into the system,” he said. “I always draw a parallel to the passive-safety systems in cars, like air bags, antilock brakes and stability-control systems.”

Howard says a typical drug costs about $300 million to develop, test and bring it to market, but that he sees a simpler, less-expensive path for ODR and hopes to have it approved within two to three years.

“Human testing will cost about $500,000 to $1 million, so it’s not big money compared to the average drug, because those are completely new compounds that have to go through all kinds of testing,” Howard said.

Ion exchange resins are already used in several approved products, and Alitair would combine it with approved drugs such as codeine, hydrocodone and oxycodone, so “it’s a much simpler path to market,” Howard said. “We’re just going to reformulate them.”

Alitair’s patent is specifically for an ionic exchange resin that binds to opioids.

He also hopes to get ODR into an existing FDA fast-track program for important drugs that might also help accelerate its path to the market.

Howard said from a business standpoint, he would like Alitair to ultimately develop a brand-name pain-killer that includes the ODR compound, but that he would make the formulation available to any manufacturer in the interest of public health.

“The goal is to develop a life-saving drug,” he said. “I want people to live.”

Howard’s background includes serving as the senior vice president of new products and business development for Chester-based Adams Respiratory Therapeutics, a subsidiary of Reckitt Benckiser, where he oversaw development of successful over-the-counter products such as Mucinex.

“This is not his first time in this arena,” Bucco said. “I plan on having a conversation with the governor about this. I served many years and was a founding member of Daytop New Jersey, and I’ve seen this epidemic first-hand. Anybody that has been involved in the substance-abuse treatment field would definitely be interested in  this.”

Christie has spent considerable time and effort in recent weeks centering the final year of his administration on battling addiction. Christie spokesman Brian Murray said he would forward information about Howard’s patent to the governor.

Staff Writer William Westhoven: 973-917-9242; wwesthoven@GannettNJ.com.

Filed under: General Problems