The FDA has approved a new pain drug from Purdue Pharma that's intended to throw up a line of defense against the abuse of an extended-release reformulation of OxyContin. But all the approval seems to have accomplished is triggering some added eye-rolling from some of the experts fighting abuse.
Purdue Pharma will build a new $59 million plant in Durham, NC, and has awarded a contract to KBR Building Group to erect the 188,000-square-foot facility.
In the wake of a lawsuit brought by two California counties against five manufacturers of prescription painkillers, the city of Chicago has filed a suit of its own. Chicago is suing the same five pharma companies--alleging, much like California does, that they overstated the benefits of opioid painkillers while deceiving the public about the risks.
California has decided to lay the responsibility for opioid overdoses, and even a resurgence in heroin use, at the feet of the drugmakers, accusing them in a lawsuit of reaping huge profits while turning a large swath of people into drug addicts.
Teva announced that its abuse-resistant version of extended-release hydrocodone--the opioid CEP-33237--aced a pivotal Phase III. Unsurprisingly, the pain drug beat out a placebo in the chronic back pain study, which sets the stage for a new drug application for later in the year. Purdue Pharma, meanwhile, has already raced to the FDA with its own tamper-resistant version of hydrocodone.
As pharmacies began dispensing Zogenix's powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.
As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.
Purdue Pharma will invest nearly $60 million in a new plant in the Raleigh/Durham, NC, area with a little help from its friends there.
Which doctors to flag for reckless OxyContin prescribing may soon be a decision that's out of maker Purdue Pharma's hands, at least in California. Thursday, a spokesman from Purdue Pharma confirmed that the company had turned over a list of 49 California doctors it suspected of risky script-writing to the Medical Board of California.
California is pushing some new legislation that drugmakers and physicians were none too happy with in its original form. But after some amendments, a slate of reforms to increase authorities' powers to crack down on risky narcotics prescribers has made its way to the desk of Gov. Jerry Brown. The three bills now await his signature to make them law.