The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.
The FDA, under pressure to help curb abuse of opioid painkillers, has taken yet another step to dampen their use. The agency said today that it is "invoking its authority" to require that long-acting and extended release drugs should only be used for severe pain and only when other measures don't work.
Mallinckrodt's treatment will offer a level of resistance to tampering with the highly addictive product, a quality that could set it apart in the competitive pain drug arena.
GW Pharmaceuticals is taking another chance at the FDA. The company is working on a new application for approval of Sativex, the cannabinoid drug now sold in Canada and Europe to treat spasticity in multiple sclerosis patients.
Issued by the Department of Health and Human Services' inspector general, the subpoena is looking for documents and information about sales, marketing and promotional activities on two formulations of Nucynta, an opioid pain reliever.
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At the very moment on Wednesday that the FDA released its draft guidance for makers of tamper-resistant prescription painkillers, Harald Stock, CEO of Grünenthal Group, was explaining why the agency should require such protection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.