(Corrects to clarify Food and Drug Administration’s description of tamper-resistant technologies in third and fourth paragraphs of story published Oct. 25.)
Zogenix Inc. (ZGNX) won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.
The Food and Drug Administration cleared the San Diego-based company’s Zohydro for the management of pain severe enough to require continuous, long-term treatment, the agency said today in a statement. Zohydro is intended as an alternative to drugs including Vicodin that mix hydrocodone with less-potent medicines such as aceteminophen.
Zogenix is counting on the painkiller to boost its $44 million in 2012 revenue from sales of a migraine treatment Sumavel. FDA advisers recommended in December that Zohydro not gain market clearance until the agency examined greater measures to curb opioid abuse. The medicine doesn’t contain the same technology some other drugmakers use to deter people from abusing their medicines, the FDA said in a response to a petition urging such drugs not be approved. Zohydro’s benefits outweighed the risks, the FDA said.
Purdue Pharma LP’s OxyContin was reformulated in 2010 to prevent people from getting immediate access to a full dose of the opioid oxycodone by chewing, cutting or dissolving the tablet, according to a statement on the FDA’s website.
Zogenix gained 36 percent to $3.04 at the close in New York, the biggest single-day increase since Feb. 27.
The FDA asked Zohydro to study the drug’s abuse potential while it’s on the market, the agency said in the statement.
The FDA will recommend by early December reclassifying hydrcodone-combinations as Schedule II substances, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said yesterday. Pure hydrocodone, such as Zohydro, already carries the stricter Schedule II rules.
Combinations are currently Schedule III on a five-stage scale that takes into account the potential for addiction, with Schedule I having the highest likelihood of abuse. The Drug Enforcement Administration, which sets the schedule, asked the FDA to recommend the stricter rules for the combination painkillers.
Schedule II drugs are limited to a 90-day supply and patients must visit their doctor for more instead of the five refills within six months for Schedule III.
Zohydro uses Alkermes Plc (ALKS)’s drug delivery technology to provide extended release technology for Zogenix. The FDA said the drug should be reserved for patients whose pain hasn’t been controlled by other medicines or who can’t tolerate other potential alternatives.
To contact the reporter on this story: Anna Edney in Washington at email@example.com
To contact the editors responsible for this story: Reg Gale at firstname.lastname@example.org Andrew Pollack, Angela Zimm