With all of the publicity (mostly negative) about the approval of the first (non-abuse-deterrent) hydrocodone bitartrate single entity extended-release (ER) product, Zohydro, by Zogenix, the race was on for the development of an abuse-deterrent formulation. On November 20, 2014, Purdue Pharma won that race with the approval of Hysingla (hydrocodone bitartrate) ER-Tablets with abuse-deterrent properties. Purdue obtained approval for 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100mg, and 120 mg tablets.
The FDA announcement states: “Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.”
The Purdue product labeling contains a significant amount of information on the testing results relative to the liking studies performed on the product and has a fair amount of information relative to the abuse-deterrent properties of the product. This is the fourth in what will likely be a string of abuse-deterrent products approved by the FDA. While the jury is still out on how effective these products are in reducing abuse, the FDA appears to be moving full steam ahead in this direction.
Questions of what will happen to the non-abuse-deterrent Zohydro product while the firm’s abuse-deterrent product remains under FDA review (as reported in the media) remains to be seen. If I had to guess, I would say the FDA is unlikely to take enforcement action and try to remove the product since the new product will likely replace the non-abuse-deterrent product in the marketplace. The only unanswered question really is, what will the FDA do if it does not make a determination that the new Zohydro abuse-deterrent product formulation meets the FDA guidance requirements?
The link to the FDA announcement for the approval of Purdue’s Hysingla product and other FDA information on the product may be found here.