Purdue Pharma and generic drugmaker Actavis have settled their patent suit over a special formulation of the painkiller OxyContin just 10 days the FDA banned generic versions that do not carry abuse resistant technology.
For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic version of the highly addictive OxyContin on the market vs. consumers with pain issues having access to cheaper meds.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
At the very moment on Wednesday that the FDA released its draft guidance for makers of tamper-resistant prescription painkillers, Harald Stock, CEO of Grünenthal Group, was explaining why the agency should require such protection from all opioids. The German company specializes in tamper-resistant pain products.
On one side stand Endo Health Solutions ($ENDP) and Purdue Pharma. On the other, generic drugmakers that want to introduce copies of big-selling, high-powered painkillers. In the middle, the FDA, which has to decide whether to allow those cheap copies onto the market.
Could biomarkers tailor the use of pain drugs? Scientists at the University of Pennsylvania hope to determine whether common painkillers such as Celebrex and Aleve can be used more effectively by identifying patients most likely to benefit--and least likely to suffer serious side effects.
On the heels of new addiction-fighting measures from FDA, Congressional reps are introducing a bill that would put the onus on drugmakers to curb abuse. The measure would require pain drugs to be formulated to deter abuse.
Making strong painkillers now comes with extra responsibility. The FDA has unveiled new measures aimed at nipping opioid abuse in the bud.
The Senate Finance Committee launched an investigation yesterday into the ties among companies that sell pain drugs, pain experts, patient advocacy groups and professional organizations, The New York Times reports.
Pfizer ( $PFE) is making a pitch for reviving the anti-nerve growth factor drug it shelved two years ago on safety concerns. The arthritis pain treatment is one of several anti-NGF drugs, so if FDA...