Chad Abshire
Staff Writer
WASHINGTON, D.C. — Two U.S. Representatives, one from West Virginia and the other from Kentucky, recently introduced a bill to increase abuse-deterrent safeguards for prescription drugs.
The Stop Tampering of Prescription Pills (STOPP) Act, was introduced by Rep. Nick Rahall (D-W.Va.) and Rep. Hal Rogers (R-Ky.), along with William Keating (D-Mass.), and would require opioid-based prescription drugs to include abuse-deterrent technologies that prevent substance abusers from crushing or dissolving prescription opioids so that they cannot be inhaled or injected to achieve an immediate high.
“Drug manufacturers have the means – and, certainly, the moral responsibility – to reduce the risk of abuse, whenever possible, for the prescription pain medications they are selling,” Rahall said. “We have a growing national epidemic on our hands and it is no longer sufficient to merely encourage drug manufacturers to do the right thing. Voluntary incentives are not enough.”
Some drug manufacturers, according to a release from Rahall’s office, now produce prescription opioids with tamper-resistant features that prevent such abuse, but the patents expire this year for brand name painkillers such as Oxycontin that include those safeguards. The STOPP Act would ensure similar generic medications include abuse-deterrent technologies.
“When Oxycontin was first approved by the FDA over a decade ago, it seemed at first glance that its extended-release technology was a godsend for patients suffering from chronic pain,” Rogers said. “What no one could foresee was that when you crush these pills, they actually create pain in the form of addiction, abuse and senseless, tragic overdose deaths.”
Executive Director of Center for Lawful Access and Abuse Deterrence, Michael Barnes, said that pharmaceuitical companies “must take responsibility for the safety of their products.”
“That’s what the STOPP Act is about. It really is that simple,” Barnes said.
“In the end, this will save lives, save medical resources, hospital beds, prison cells, broken homes, and orphaned little ones,” Rahall said. “It will save commerce and all levels of government scarce resources. Yes, that means savings to the consumer and taxpayer alike… Making these pills harder to abuse is a needed step in curbing the abuse and overdose levels we see in West Virginia, and all across our great nation.”
Elite Pharma uses multiple beads in a tablet or capsule. The beads are identical but the Naltrexone is formulated to not be released. This works for all opioids and is not that complicated to formulate for any opioid. If you think about it, its actually pretty simple. The company almost went out of business during the downturn in the market and because of poor management but they managed to avoid bankruptcy and pursue what had the company on the AMEX almost 20 years ago. The company has had many financial setbacks, but the technology works as they have previously passed Ph1 and PH2 under an NDA/IND for Oxycontin. Fortunately, they have been able to gain FDA approval for about 8 generic drugs over the past 18 months, with many partnerships with companies as large as Actavis/Watson and Hi-tech Pharmacal. They expect to be cash flow positive here shortly and announced studies about to commence for a generic abuse resistant product.
Other companies have tried to make it simply difficult to crush or melt the pills but drug addicts have proven to be able to beat these mechanisms via an oven, microwave oven and a little creativity. Unfortunately, some have already died when they injected these reformulated drugs due to all the ingredients and formulation it takes to make a pill difficult to crush or tamper with. Also easy to google how to beat these mechanisms.
There is a lot of misinformation as this is a 20 billion dollar market so your best bet is to investigate these companies for yourselves and contact their Investor relation departments. Many Pharma companies stand to lose a ton of revenue if they can not come up with abuse resistant technologies of their own or license from someone like Elite. Elite is expecting to receive a patent here shortly for methods of making a drug abuse resistant. It has been approved if you check the USPTO site.