The latest opioid approved by FDA will be “expected” to reduce abuse by only one route — injection — in its official labeling.
In a carefully-worded press release, drugmaker Egalet said its extended-release morphine drug Arymo ER “increased resistance to cutting, crushing, grinding or breaking using a variety of tools. Due to its physical and chemical properties, Arymo ER is expected to make abuse by injection difficult.”
In an FDA advisory committee meeting last year, participants voted that the drug could deter abuse via the oral, nasal, and intravenous routes of abuse. But there were several reasons only the intravenous route won labeling.
An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has “marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties.” MORE HERE
Interesting article, placebo’s as effective as meds.
Drug companies have a problem: they are finding it ever harder to get painkillers through clinical trials. But this isn’t necessarily because the drugs are getting worse. An extensive analysis of trial data1 has found that responses to sham treatments have become stronger over time, making it harder to prove a drug’s advantage over placebo.
The change in response to placebo treatments for pain, discovered by researchers in Canada, holds true only for US clinical trials. “We were absolutely floored when we found out,” says Jeffrey Mogil, who directs the pain-genetics lab at McGill University in Montreal and led the analysis. Simply being in a US trial and receiving sham treatment now seems to relieve pain almost as effectively as many promising new drugs. Mogil thinks that as US trials get longer, larger and more expensive, they may be enhancing participants’ expectations of their effectiveness.
See the entire article here: http://www.nature.com/news/strong-placebo-response-thwarts-painkiller-trials-1.18511?%3Fftcamp=crm%2Femail%2F%2Fnbe%2FFirstFTEurope%2Fproduct
Opioid prescriptions have increased three-fold over the past two decades, and we have seen how this skyrocketing availability of medications has helped create a new drug abusing population, some of whom suffer severe health consequences. More deaths now occur as a result of overdosing on prescription opioids than from all other drug overdoses combined, including heroin and cocaine. The opioid epidemic is tied closely to another epidemic in our country, that of chronic pain—although the ties are very complex. Read More HERE