Pierre Geoffroy, VP, Early Phase Unit, INC Research, told In-PharmaTechnologist.com “the [US] FDA is proactive in coming up with formulations and regulations for highly abused drugs.
“But I think in Europe the EMA [European Medicines Agency] has been lagging far behind and I think part of the logic there has been an underlying belief addiction is not as big a problem in Europe as elsewhere.
“It’s bizarre to me that on this side of the Pond so much effort is made to sabotage the efforts of drug abusers, but there’s nothing in Europe - no attempt to try to counter the desires [of drug abusers]. Regulatory agencies there seem somewhat reluctant.”
No data on European misuse
When In-PharmaTechnologist.com put these comments to the EMA its spokeswoman responded it was updating guidance on medicines for neuropathic and nociceptive (nerve fibre) pain.
“The draft guideline explicitly requires that the potential of abuse, dependence and misuse should be assessed, however there is no reference to abuse-deterrent formulations of opioids in it at the moment,” said Sophie Labbé, EMA spokeswoman.
However Labbé said the Agency did not monitor “the abuse of prescription drugs in the EU per se” and could not provide data on it.
Under 2012 pharmacovigilance guidelines, harmful effects caused by the abuse of medicines are now counted under the definition “adverse reaction”, and submitted to Eudravigilance, the EU database of drug reactions, Labbé told us. However “this information is not collated across medicines or classes of medicines,” she added.
The EMA did not answer our reporter’s question as to whether the EMA co-ordinates with any European abuse liability trials similar to INC’s in North America.
On Tuesday, our sister publication Outsourcing-Pharma.com spoke to VPs at INC Research conducting abuse liability trials to test drugs’ potential for misuse by recreational users.
They also ran “proof-of-concept” studies, allowing drug developers to test physical and chemical barriers to misuse, Geoffroy said.
Much illicit use of prescription drugs occurs when users administer oral medicines by alternate routes such as snorting or injection. To inject an oral therapy, users often crush the pill, dissolve it in water, filter and inject it.
“Formulators add excipients so when the drug comes into contact with water or a solvent, it turns into a viscous gummy substance,” said Geoffroy. “It cannot be drawn into a syringe or pass through the nasal lining.”
“This technology has been focused on opioids, but they’re looking now at other types of drugs. I was at a conference just last week about potential anti-abuse technologies for ADHD drugs, which are an increasing problem for adolescents who take them as a stimulant.”
Aside from physical barriers, some drug developers are using a pharmacological approach, said Geoffroy.
Embeda, created by King Pharmaceuticals, were morphine capsules which contained a central pallet of naltrexone, an opioid antagonist. “If someone tried to manipulate the pallet, the naltrexone would be released,” said Geoffroy. “If it was taken as directed, the naltrexone would pass straight through the patient and remain sequestered.”
Similarly, Suboxone capsules contain both the opioid buprenorphine and the antagonist naloxone to deter injection. If the medicine is tampered with and naloxone is released, it react with recepors and “the user will actually feel sicker rather than good,” said Geoffroy.