Drugmakers Hurry to Develop Safer Long-Acting Opioids
The race to create an abuse-deterrent version of a once-daily analgesic is heating up, with Purdue Pharma taking the lead in its competition with Zogenix’s controversial painkiller Zohydro ER.
Purdue Pharma said that it received FDA priority review for its once-a-day, single-entity hydrocodone bitrate tablet, meaning it could be available this fall. The news comes after Zogenix announced plans to market its own abuse-deterrent versions of Zohydro ER (hydrocodone bitrate), with the first of two coming to market by early 2015.
Purdue filed its NDA for the hydrocodone bitrate tablet back in April, and the FDA granted an October PDUFA date, the company said. The tablet will feature abuse-deterrent properties that make it difficult to chew, snort or inject.
The Stamford, Conn., drugmaker previously conducted a 588-patient Phase III clinical trial to support regulatory approval. Purdue declined to estimate sales for the tablet, which is similar to abuse-deterrent OxyContin (oxycodone HCl), spokesman Bob Josephson said.
Meanwhile, Zogenix has laid out plans for its two new formulations of Zohydro. By October 2014, the San Diego-based drugmaker plans to file an sNDA for a version that will be difficult to snort or inject; the hope is to make it available by early 2015. The company is also developing a tablet formulation that will incorporate those features, as well as make it harder to crush or chew. Zogenix hopes to file an NDA for that version during the first half of 2016.
The company previously had estimated that no abuse-deterrent Zohydro would be available before 2016. But the drug ignited a huge controversy when it launched in March, becoming the first hydrocodone product not used in combination with another active ingredient.
State and federal lawmakers worried that Zohydro’s lack of abuse-deterrent properties would result in it being heavily abused and Massachusetts went so far as to ban sales of the drug, a move later overturned by a federal judge. The FDA has hinted that it might support longer market exclusivity for such abuse-deterrent products and last year issued guidance on how to develop such opioids.
The company said its plans regarding abuse-deterrent formulations of Zohydro were not affected by Purdue’s pursuit of a single-entity hydrocodone tablet.
As of June 13, 8,935 prescriptions had been written for the painkiller, the company said. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.