Zogenix Submits Supplemental NDA for Abuse-Deterrent Formulation of Zohydro

Drugmaker Zogenix said it has submitted a sNDA for an abuse-resistant version of its controversial opioid agonist Zohydro ER.

The formulation would contain new inactive ingredients that are intended to make Zohydro ER (hydrocodone bitartrate) more difficult to snort or inject. If approved, the company said it expects to launch the drug by the second quarter of 2015.

Zogenix President Stephen Farr said the new formulation is only one safeguard for the product. Not only has Zogenix implemented a Risk Management and Evaluation Strategy, but it has provided patients with free locking bottle caps and discounts for home safe-storage units, he noted.

Zohydro ER drew fire soon after it was approved last October, with lawmakers calling on FDA to reverse its decision and multiple states seeking to either ban or severely limit prescribing the drug.

Andrew Kolodny, a physician and head of Physicians for Responsible Opioid Prescribing, contends that any new abuse-deterrent Zohydro won’t do much to curb the abuse that critics were worried about. “Most people with addiction stick to swallowing pills whole,” he said.

The FDA continues to maintain that new opioids are needed for the millions of Americans living with chronic pain.

Kolodny disputes this position, pointing out that Zohydro is not often prescribed in the U.S. There was never a need for this product, he said, as there are many effective opioids already on the market.

Zohydro ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.