A controversial new painkiller is no more powerful or addictive than other opioid medications already on the market and pain patients should have access to it, according to the head of the Food and Drug Administration.
“Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine,” said FDA Commissioner Margaret Hamburg in a blog on the FDA website.
A wave of controversy has surrounded Zohydro – the first single ingredient hydrocodone painkiller sold in the U.S. — since its introduction in March. Some addiction treatment experts have claimed the new painkiller – which does not come in an abuse deterrent formula — will fuel a new wave of narcotic addiction and overdoses.
Last month Massachusetts Gov. Deval Patrick tried to ban the prescribing and dispensing of Zohydro in his state, a move that was blocked by a federal judge who ruled the governor was interfering with the authority of the FDA to regulate prescription drugs.
The agency approved Zohydro last year over the objections of its own staff and advisory committee, which warned the painkiller could be abused even more than currently available hydrocodone products.
“The approval of Zohydro is not likely to significantly change overall opioid prescribing and use by patients suffering from pain,” said Hamburg. “Rather, the most likely patients for this medication are those who are currently taking an immediate release hydrocodone product chronically, or people taking another extended-release/long-acting opioid. And this drug is unlikely to increase the number of people abusing opioids.”
“We have heard from many people who must cope with often severe pain on a daily basis. These are people who need a variety of therapies to have any hope for a quality life.”
After the judge ruled his emergency order was unconstitutional, Gov. Patrick announced new restrictions on Zohydro that require doctors to evaluate a patient’s substance abuse history, provide a letter of medical necessity to pharmacies, and sign a pain management treatment agreement with patients who are prescribed the drug. In addition, physicians must also use the state’s online prescription drug monitoring program, which tracks the prescriptions of controlled substances such as Zohydro.
Zogenix (NASDAQ:ZGNX), Zohydro’s San Diego-based drug maker, filed a federal lawsuit against Massachusetts this week saying the new regulations are unconstitutional and impose “draconian” restrictions that “amount to an effective ban of the drug”.
While saying the restrictions “are precisely what responsible physicians should be doing,” Hamburg said it was unfair to single out Zohydro.
“We can’t just focus on one drug, Zohydro, alone. These requirements would not apply to the prescribing of any of the other opioids on the market that account for some 250 million prescriptions and 18 billion tablets each year. Unfortunately, to date considerable misinformation appears to be diverting attention from more comprehensive policy solutions that apply to all opioids,” Hamburg said.
The FDA Commissioner said regulations should address “the real root causes of the problem,” which are excessive prescribing of opioid pain medications, improper disposal of unused drugs, and inadequate physician and patient education.
“Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective,” said Hamburg. “At the end of the day, the complex public health challenge of opioid abuse requires a comprehensive and science-based approach involving federal and state governments, public health experts, opioid prescribers, addiction experts, patient groups and industry. Then, and only then, will we truly solve this problem and protect the public health.”