Purdue wins a pain pill approval with Zohydro in its crosshairs

The FDA approved Purdue Pharma's latest pain drug, a hydrocodone formulation designed to prevent abuse, potentially spelling trouble for Zogenix ($ZGNX) and its controversial Zohydro.

Purdue's drug, to be marketed as Hysingla, is an extended-release tablet of pure hydrocodone designed to relieve severe chronic pain. Such opioid treatments are common agents for drug abuse, as users often crush them to crack their timed-release coatings and create a snortable or injectable substance. Hysingla, however, is difficult to crush, break or dissolve, the FDA said, and it reduces to a thick hydrogel when melted, making it nearly impossible to inject.

Those properties should reduce, though not altogether prevent, abuse of Purdue's drug, the agency said, and regulators have approved tablets containing up to 120 mg of pure hydrocodone. Along with its approval, the FDA is asking Purdue to carry out postapproval studies to determine the real-world effectiveness of the drug's abuse-deterrent features.

Janet Woodcock

Purdue's success comes about a year after the agency made the surprise move of OKing Zogenix's treatment, a pure hydrocodone formulation whose potential for abuse led a panel of FDA advisers to strongly recommend against approval. Physicians and drug abuse specialists promptly questioned the agency's decision, with some castigating Zohydro as an irresponsibly powerful product and petitioning the FDA to yank it off the shelves.

While that created serious problems for Zogenix and its marketing plans for the drug, it spawned a sort of white-knight opportunity for Purdue and its then-Phase III competitor. "We firmly believe that the market must move to all abuse-deterrent formulations," Purdue R&D chief Gary Stiles told Bloomberg in March. "There's not a technical reason why we and others can't do that."

The FDA approved Hysingla based on a 905-patient pivotal trial in which the drug proved effective for sufferers of chronic low back pain, and Purdue's pill also scored well in studies designed to test its abuse-deterrence, the agency said.

"Preventing prescription opioid abuse is a top public health priority for the FDA," CDER director Janet Woodcock said in a statement, "and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain."

- read the announcement

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