Purdue’s Abuse-Resistant Pill Gets FDA Priority Review
Purdue Pharma Inc.’s tamper-resistant competitor to Zogenix Inc. (ZGNX)’s powerful pain pill has received priority review from U.S. regulators, the company said. Zogenix shares fell the most in almost four months.
The Food and Drug Administration will expedite the application process for Purdue’s hydrocodone tablet, the closely held Stamford, Connecticut-based drugmaker said in a statement today. The review is expected to take six months instead of the standard 10 months, Purdue said.
The chronic pain medication is hard for abusers to crush and snort or inject, making it a threat to Zongenix’s Zohydro ER, which doesn’t have abuse-deterrent features. Zohydro, approved by the FDA in October, is the only pure hydrocodone painkiller on the market. Other comparable drugs, such as Vicodin, contain acetaminophen, which can cause liver damage.
Politicians have petitioned the FDA to pull Zohydro from the market, concerned that the pill, which comes in dosages of as much as 50 milligrams, will exacerbate opioid addictions and related deaths. Massachusett’s Governor Deval Patrick imposed restrictions on Zohydro prescriptions after a federal judge struck down an emergency ban.
The FDA has said that Zohydro could be pulled from the market if San Diego-based Zogenix or another manufacturer gets an abuse-deterrent formula approved. Zogenix said in November that it was developing an tamper-resistant formula with Altus Formulation Inc., a Montreal-based drugmaker. Zogenix expects to file an application to the FDA by October, the company said on July 2.
Zogenix declined 13 percent to $1.86 at the close in New York, the biggest single-day drop since March 12.
Further competition may come from Teva Pharmaceuticals Industries Ltd., which is planning to submit a version of the drug to the FDA by the end of the year. It is in the last of three stages of clinical trials usually required by regulators. Pfizer Inc.’s drug, also in Phase 3 trials, has been found to have lower abuse potential in recreational opioid users.
U.S. deaths from drug abuse have tripled since 1990, according to a 2013 report from the Centers for Disease Control and Prevention in Atlanta. There were 36,000 deaths in 2008, mostly from prescription drugs, and 3 of 4 prescription overdose deaths were attributed to painkillers.
Purdue makes OxyContin, a painkiller first approved by the FDA in 1995. In 2010, Purdue reformulated the drug to be abuse-resistant.
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