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GEN News Highlights : Apr 5, 2012
Lawmaker Criticizes Continued Development of Pure-Hydrocodone Drugs
A Congressional co-sponsor of a bill that would force drugmakers to include anti-abuse features in new medicines has taken aim at the development of a new class of pain medicine that packs up to 10 times the addictive painkiller hydrocodone as existing medications such as Vicodin.
“Why is it necessary to go further in a pure form?” U.S. Rep. William Keating (D-MA) told The Enterprise of Brockton, MA, adding that allowing a stronger form of hydrocodone did not make sense. A former district attorney for Massachusetts’ Norfolk County, Keating is urging FDA to reject the new drugs: “To me, it wouldn’t be a close call if I were in that position.”
To that end, Rep. Keating has co-sponsored The Prescription Drug Abuse Prevention and Treatment Act (HR 1925). Introduced May 13, 2011, by Rep. Nick J. Rahall II (D-WV), HR 1925 would give FDA authority to require drug manufacturers to make pills harder to abuse. That bill has a companion Senate measure, S.507, introduced by Sen. John D. Rockefeller IV (D-WV).
Keating’s measure is one of two bills introduced in Congress aimed at stopping pain drug abuse. Rep. Mary Bono Mack (R-CA) has introduced HR 1316, the Stop Oxy Abuse Act of 2011, which would direct FDA Commissioner Margaret Hamburg M.D. within 90 days to take such actions needed to modify existing approvals and limit any subsequent approvals for any drug containing controlled-release oxycodone hychloride for severe-only pain instead of moderate-to-severe pain. The rule would be applied to drugs introduced into interstate commerce 180 days after the bill is enacted. The bills have all been stuck in committee for close to a year.
Supporting Rep. Keating’s stance is the founder of a nonprofit support group for parents and family members dealing with a loved one addicted to heroin, OxyContin, and other drugs. “How could this even be happening? How could this even be considered?” Joanne Peterson, executive director of Learn to Cope, told The Enterprise. “Do they not know from what we’re already experiencing now?”
One statistic cited by opponents of the new pain drugs: From 2002 to 2007, Massachusetts reported 3,236 overdose deaths, mostly attributed to OxyContin and a cheaper alternative, heroin.
At issue are new pure hydrocodone drugs in development by several companies, unlike Vicodin, which combines hydrocodone with acetaminophen. Developers of the new drugs have contended that their pure hydrocodone products will benefit some patients who are at risk of liver problems posed by high doses of acetaminophen and because the more potent new pills will require doctors’ prescriptions with every refill, versus up to five refills without a doctor’s say-so now possible with Vicodin and other hydrocodone-acetaminophen drugs.
One of the new antipain medications under development is a 12-hour extended-release form of hydrocodone being developed by Zogenix. According to its 10-K 2011 annual report filing with SEC, Zogenix will submit an NDA “early in the second quarter to begin marketing its product, Zohydro, following success in earlier clinical trials. Zogenix, which is Zohydro’s lead product candidate, plans to begin marketing Zohydro next year.
Zogenix stated in its annual report, “We believe our lead product candidate, Zohydro, has the potential to be an important therapeutic alternative to existing hydrocodone products including the branded products Vicodin, Norco, Lorcet, Lortab, and their generic equivalents, which contain the analgesic combination ingredient acetaminophen and, if taken in high quantities over time, can lead to serious side effects such as liver toxicity.
“If we receive FDA approval, we intend to consider co-promotion and other partnering opportunities for Zohydro and an expansion of our sales and marketing infrastructure including expanding our field sales force to between 170 and 220 representatives to both launch Zohydro and continue to support Sumavel DosePro,” a needle-free subcutaneous delivery system for sumatriptan for acute treatment of migraine and cluster headache. The sales force now stands at 116 professionals.
OxyContin maker Purdue Pharma has joined with Cephalon, a unit of Teva Pharmaceuticals, to conduct late-stage trials of their own tamper-deterrent or “TD” hydrocodone. "We believe that's another product that will get approved and can be a three-, four-, $500 million product in a couple of years," William Marth, president and CEO of Teva Pharmaceuticals Americas, said during a preview of TD Hydrocodone at the 30th Annual JP Morgan Healthcare Conference, held in January, according to news reports.
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