Score One for Chronic Pain Patients!
Since the FDA approved Zohydro ER last October, there has been a storm of controversy. Zohydro ER is an extended-release version of the opioid pain reliever hydrocodone.
On the Plus Side
Zohydro ER provides three potential benefits previously unavailable to pain patients in the U.S.
It is the first single-entity form of hydrocodone available. All other forms of hydrocodone on the U.S. market are combined with another weaker pain reliever like acetaminophen, ibuprofen or aspirin, which can be hard on the liver and/or stomach.
It is the first extended-release version of hydrocodone available, which could be a real plus for patients who have chronic, round-the-clock pain.
It is available in higher doses than other hydrocodone products on the market, which means chronic pain patients may not have to progress to other more potent opioids like oxycodone or morphine.
On the Minus Side
A number of people, including several elected government officials, are very upset about the approval of Zohydro ER. They see it as yet another opioid drug that has great potential to be abused. One of their biggest concerns is that Zohydro ER is not yet being manufactured in an abuse-resistant formulation. They say that addicts can potentially crush the capsules, thwarting the slow-release properties, which could possibly lead to a fatal overdose.
Battle Lines Are Drawn
The backlash began shortly after Zohydro ER's approval as state and federal officials around the country began to rebel. A recent AP article reports:
Twenty-eight state attorneys general signed a letter asking the FDA to reverse their decision or at least require the manufacturer to make the drug abuse-resistant.
Sen. Joe Manchin (W. Va.) and Rep. Stephen Lynch (Mass.) introduced legislation that would force the FDA to withdraw the drug.
Vermont Gov. Peter Shumlin issued an emergency order that would make it harder for doctors to prescribe Zohydro ER.
Massachusetts Gov. Deval Patrick ordered a ban on prescribing and dispensing the drug until it is marketed in an abuse-resistant formulation.
The Cavalry Arrives
In recent years it feels like our government has turned a deaf ear to the needs of chronic pain patients. In their efforts to reduce prescription drug abuse, they have made it much more difficult for real pain patients to get the medications we need. The efforts of some officials to take Zohydro ER off the market felt like once again our needs were being ignored. But thankfully, this time two key federal officials and one judge spoke up and acted on our behalf!
First, on April 3, Kathleen Sebelius, then Health and Human Services Secretary, and FDA Commissioner Dr. Margaret Hamburg called for a balanced approach in the fight against prescription drug abuse and preserving the protection of the needs and rights of patients suffering from severe chronic pain. It was an impressive showcase of a unified front.
Zogenix, the manufacturer of Zohydro ER, issued a press release the next day saying, “We agree with Commissioner Hamburg's call for preserving access to pain medicines for the patients who need them the most. We believe that allowing politicians who have incomplete and false information to force a reversal of the FDA's considered decision to approve Zohydro™ ER – or any other medication – after that agency's painstaking review, would set a very dangerous precedent.”
Then yesterday, Zogenix announced that a federal judge in the U.S. District Court in Massachusetts entered an order, preventing the implementation of the Commonwealth's ban of Zohydro™ ER on Constitutional grounds. This order will become effective on April 22, 2014.
They went on to say that the court decision supports the importance of upholding the Constitutional principle at the heart of this case. The FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This approval was based on a thorough review of the safety and effectiveness data in support of Zohydro ER. Allowing states to overturn the decisions of medical and scientific professionals at the FDA, which is the federal agency Congress has authorized to regulate matters involving patient safety and the effectiveness of medications, would set an alarming precedent with respect to the federal regulation of access to new prescription medications. After careful consideration, the District Court agreed.
Many thanks to Secretary Sebelius, Commissioner Hamburg and the judge in Massachusetts who stood up for chronic pain patients! Let's hope this starts a trend.