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 north-of-the-border solution comes amid climbing heroin abuse in the US.
The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.
Drug makers favor big spending on speakers' events and doctor outreach.
The reveal comes days before hydrocodone products jump to a more restrictive access tier.
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 drugmaker is collaborating with Charleston Laboratories in the development and commercialization of hydrocodone products. The deal means Daiichi Sankyo now has two pipeline opiates.
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.
Researchers at Montreal's McGill University survey the explosion in prescription painkiller use and abuse.
Express Scripts said that family and internal medicine doctors were the top opioid prescribers between 2011 and 2012.
The Windy City seeks $9.5 million in damages in a lawsuit that accuses manufacturers of misleading consumers.
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.
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.
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