FDA Delays Zohydro Decision

FDA Delays Zohydro Decision

The Food and Drug Administration has notified Zogenix Inc. that it is unlikely to reach a decision on the company’s powerful new painkiller, Zohydro, by its March 1 target date. The move is being interpreted by some analysts as a sign that the agency might ignore the recommendation of an advisory committee and approve the use of Zohydro to treat moderate to severe pain.

“The FDA has not provided the Company with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. The Company has not been informed of any deficiencies in the application during the review process to date,” Zogenix (NASDAQ: ZGNX) said in a statement.

thumbIf approved, Zohydro would be the first pure hydrocodone painkiller sold in the U.S. Combination versions of hydrocodone, such as Vicodin, typically require dosing every 4 to 6 hours, but extended release Zohydro could be taken just twice a day.  About 47 million patients received prescriptions for hydrocodone products last year, according to the FDA.

In December, a panel of pain experts advised the FDA to reject Zohydro because of its potential for abuse.

“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff wrote in a report to the Anesthetic and Analgesic Drug Products Advisory Committee. The committee voted 11 to 2 against Zohydro, but the FDA is not required to follow the recommendations of its advisory committees.

“We believe this (the delay) could be a positive signal for eventual approval of Zohydro ER,” Wells Fargo analyst Michael Tong wrote in a research note to clients. Tong says the chances of eventual approval were “high” and rates Zogenix stock as “outperform.”

“Although FDA did not indicate the reason for the delay, it indicated that the delay will likely be brief (weeks instead of months). In communicating this delay to ZGNX, FDA did not notify ZGNX of any deficiencies in the NDA (new drug application), and did not request any additional information from the company,” Tong said.

“The fact that the Agency did neither suggests to us that FDA is quite close to making a decision, and that decision could run contrary to the AdComm (advisory committee) recommendation.”

If approved, Zohydro ER would be classified as a Schedule II drug, making it subject to stricter prescribing and dispensing rules. Currently hydrocodone combination products are classified as Schedule III drugs, although the FDA is considering reclassification of them as Schedule II controlled substances.

“We are confident in the Zohydro ER program and our NDA submission and are committed to working with the FDA while it completes its review,” said Stephen Farr, president and chief operating officer of Zogenix. “We believe there is an important medical need for an extended- release hydrocodone medicine without acetaminophen and that Zohydro ER can fill this need based on its safety and efficacy profile.”

One possible hurdle for Zogenix in getting FDA approval is that Zohydro was not developed with a tamper-resistant formulation to prevent abusers from snorting or injecting the drug. Company officials have said they were working on a tamper resistant version, but it was a “few years” away.

Authored by: Pat Anson, Editor