The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.
On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.
Marketing can be a bit like dating. If you're not getting results with one target, then it's best to focus on someone else. That's exactly what Zogenix is doing, by tweaking its Zohydro launch strategy.
Already dealing with a growing backlash from politicians and law enforcement accusing it of recklessly marketing opioids, the pharmaceutical industry now has to face down a report that a hospital pharmacy director for years was walking out with thousands of oxycodone pills. It is a revelation that is sure to add to the growing debate.
When Insys Therapeutics won approval for its new narcotic painkiller, Subsys, in 2012, few predicted the product would find much of a market, because the FDA limited its use to cancer patients who were already on powerful painkillers. But in 2013, the product raked in $96 million in sales, and the company's stock price quintupled to $25 a share.
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.
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.