The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
The reason: opioids.
The $300,000 grant will go towards an abuse-deterrent technology.
FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
The painkiller's marketer will look to partner with another manufacturer to better target primary care physicians, and will also reexamine its sales territories.
Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.
Purdue Pharma expects the FDA to vote yea or nay on the drug by October.
Zogenix is working on a less easily abused formulation of its controversial prescription painkiller.
The Centers of Disease Control reports that prescribers wrote enough painkiller prescriptions to give one bottle to every adult in the US in 2012.
Researchers at Montreal's McGill University survey the explosion in prescription painkiller use and abuse.
A USA today analysis shows Medicare painkiller prescriptions rose 30% between 2007 and 2012.
Express Scripts said that family and internal medicine doctors were the top opioid prescribers between 2011 and 2012.
Orange and Santa Clara counties are suing painkiller makers like Purdue and Endo, a suit akin to deceptive ad cases launched against the tobacco industry.
The regulator defends its approval decision in a web post.
Two drugmakers, Purdue Pharma and Teva, have abuse-deterrent hydrocodone medications either under FDA review or in late-stage testing.
The candidate would be the first to put oxycodone and morphine in one capsule.
A District Court says Massachusetts cannot ban opioid painkiller Zohydro.
The Bay State is saying no to the controversial prescription painkiller.
West Virginia's Joe Manchin has sponsored a bill to push pain medication Zohydro off the FDA's approval list.
A rival's late-stage trial results suggest the pain med may have a short market life. The key: an FDA division head's documented willingness to overturn the approval should another pain option surface.
A study says that more opioid abusers get their medications via prescription than they do second-hand.
New York's health commissioner says its painkiller prescription database has cut painkiller doctor shopping by 75%.
Purdue Pharma says it will appeal.
The drugstore chain says it has cut off over-prescribers of tightly controlled medications.
HHS is looking into how J&J marketed opioid painkiller Nucynta, adding to the firm's list of investigations and those of the industry as a whole.
The drug maker can now add five new doses to its generic Opana ER offerings.
Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.
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