The FDA issues restrictions yesterday to curtail opioid abuse and turn around today and approve a more powerful opioid. But then this should give NKTR a lock on getting their drug approved.
The Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely-abused prescription painkiller.
The agency said Friday it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.
Hydrocodone is currently sold in combination pills like Vicodin to treat pain from injuries, surgery, arthritis and migraines. The new drug from Zogenix is the first pure hydrocodone drug approved in the U.S.
The approval came as a surprise since the agency's own panel of outside advisers gave the drug an overwhelmingly negative review last year. The panel of pain specialists voted 11-2, with one abstention, against approving the drug, questioning the need for a new form of one of most widely-abused prescription drugs in U.S.
Zohydro's approval was quickly criticized by patient safety advocates who had urged the FDA to reject the drug at the public panel last December.
"We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake,'" said Avi Israel of Buffalo, N.Y. Israel's son Michael committed suicide in 2011 while struggling with painkiller addiction. Israel is the founder of a group called, Save the Michaels of the World, which aims to combat painkiller abuse in young people.
Removal of Acetaminophen is their differentiator. FDA is VERY aware of, and concerned about, the issues related to Acetaminophen. The 11-2 panel vote was an example of logic losing to politics. Powers that be understand there is true BENEFIT (less harm) for many patients. Hydrocodone is on the market, and presently needs to be, until we get 181. This version/option just makes it less damaging for many.
"Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen. The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury."
"Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products."
“A significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients.”
Here what they did vs. Nektar ,,,,
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of HC-CR vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call
The Zohydro Phase III and NKTR-181 Phase II were essentially the same study design. The difference is that the Zohydro arm pain scores effectively separated from placebo (p=0.008). More than twice as many patients in the Zohydro arm achieved both 30% and 50% pain improvement compared to placebo (p