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Morphine is a prescription medicine used to treat acute pain.

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Several pharmaceutical products are liable to 'abuse' or use outside their prescription, which frequently involves their injection. Examples are slow-release forms of morphine and oxycodone, and sublingual buprenorphine.

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LAS VEGAS — As drug misuse, abuse, and diversion reach epidemic proportions across the United States, pharmaceutical companies are at various stages of perfecting technologies that tackle this problem.

One such company is Egalet Corp, which released study for its abuse-deterrent products during the recent PAINWeek meeting here. Using new technology, the company has developed a morphine product that's difficult to inject and an oxycodone product that deters snorting. The US Food and Drug Administration FDA has developed guidelines for pharmaceutical companies to conduct abuse-deterrent research that were finalized earlier this year, Dr Dayno pointed out.

Such research falls into four : 1 laboratory-based studies of the physical and chemical aspects of the technology, 2 clinical pharmacokinetic studies.

New tamper-proof pain products in the pipeline

One of Egalet's products — EG — is an abuse-deterrent extended-release morphine that uses its proprietary Guardian Technology, creating a formulation that is almost impossible to get into as syringe. Morphine is typically abused through injection, Dr Dayno How to shoot up morphine pills. Two category 3 studies — one comparing oral EG with MS Contin and the other intranasal administration of EG with MS Contin — showed a ificant decrease in "maximum drug liking" by nondependent drug users.

As Dr Dayno explained, participants in such studies are given placebo and the study drugs in a blinded fashion and asked to rate their "high" and how much they liked the experience on a visual analogue scale. As well, an analysis of the "abuse quotient" that indicates pharmacokinetically how high participants are likely to get, showed that this quotient was reduced ificantly for both oral and intranasal EG compared with MS Contin. EG is in late-stage development for the management of pain severe enough to require daily around-the-clock opioid treatment and for which alternative treatments are inadequate.

Another of Egalet's products — EG — uses the same proprietary technology, but in this case, the inner matrix containing the active pharmacologic ingredient is encased in an almost plastic-like shell. The tablets are actually molded under high pressure and temperature.

Injection of pharmaceuticals deed for oral use: harms experienced and effective harm reduction through filtration

The preferred way to abuse oxycodone products is to snort them. However, once ingested, "there is normal release and normal absorption" of the drug, said Dr Dayno. A category 1 study compared EG with the abuse-deterrent formulation of oxycodone hydrochloride OxyContinPurdue Pharma.

EG had fewer peaks and troughs compared with the reformulated OxyContin, providing a smoother release profile, he said. The study also concluded that the same level of manipulation effort produced larger particle sizes of EG, which are more difficult to snort, compared with OxyContin.

The effort yielded one sixth the particle size output that might be suitable for snorting, said Dr Dayno. The same technology could be used to deter abuse of other classes of drugs, including stimulants and amphetamines, he said.

While these new products may deter injection and snorting, they don't address the issue of multidosing: abusers taking multiple pills to get high. However, he noted that multidosing is not a preferred method of abuse. Taking multiple tablets at once doesn't produce as much of a high as snorting or injecting — or as quickly.

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Abuse-deterrent technologies will add to the cost of pain relief medications, but if they crack the drug abuse problem, they will reduce costs to the healthcare system in the end, said Dr Dayno. Dr Dayno believes this new technology will go a long way to addressing the growing problem of drug diversion.

Commenting on this new abuse-deterrent technology for Medscape Medical NewsJoseph Pergolizzi Jr, MD, chief operating officer, Nema Research, Bonita Springs, Florida, said it promises to deter abuse while maintaining analgesic effect. That's really what we want to try to do.

But still, added Dr Pergolizzi, abuse-deterrent formulations are, in his view, "at the very infantile stage of development. The studies were funded by Egalet. Dayno is employed at Egalet. Dr Pergolizzi has disclosed no relevant financial relationships.

Send comments and news tips to news medscape. Freelance writer, Medscape Disclosure: Pauline Anderson has disclosed no relevant financial relationships. You've successfully added to your alerts. You will receive when new content is published.

Effect of filtration on morphine and particle content of injections prepared from slow-release oral morphine tablets

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