(Corrects to clarify Food and Drug Administration’s description of tamper-resistant technologies in second and third paragraphs of story published April 7.)
April 7 (Bloomberg) -- Zogenix Inc., whose shares slumped after Massachusetts Governor Deval Patrick said he would ban its painkiller Zohydro over abuse concerns, sued to stop him, saying the move contradicted the Food and Drug Administration’s approval of the medicine.
Zohydro, approved in October, 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.
“When FDA approved Zohydro, it considered but rejected the idea of requiring the drug to utilize abuse-deterrent technology,” Zogenix said in the complaint, filed today in Boston federal court.
Zogenyx’s drug, made of pure hydrocodone, is intended as an alternative to Vicodin and others that mix hydrocodone with less-potent medicines such as aceteminophen. Patrick, in a March 27 statement, said Massachusetts faced “an epidemic of opiate abuse” and it would be treated as a public health crisis.
Zogenix shares fell 16 percent to $2.46 since Patrick’s announcement, when he said he would seek to stop physicians from prescribing the drug.
The governor’s “unilateral action was taken without any communication or advanced notice” after the company wrote him and requested a meeting to discuss the product, Zogenix said. The request wasn’t answered, the San Diego-based company said.
Patrick’s office declined to immediately comment today.
The case is Zogenix v. Deval Patrick; 14-11689; U.S. District Court; District of Massachusetts (Boston).
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