In previous blogs (here, here, here, and here), we discussed abuse-deterrent formulations and the potential “creep” in applying this approach towards substances other than opioids. So far, we have not seen a big move in that direction, most likely because of the lack of any great success of currently approved abuse-deterrent formulations from actually preventing or reducing abuse.
The FDA has held a public workshop previously on stimulant products and is now set to hold another workshop titled “Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives,” which will be held on July 12th and 13th and put on by Duke’s Margolis Center for Health Policy in conjunction with the FDA. Registration is through the Duke-Margolis site here.
In its workshop announcement, the FDA notes that there is substantial abuse of benzodiazepine products alone and in combination with alcohol or other drugs. The Agency discusses its previous moves (primarily labeling changes) to improve the safe use of these products. Further, it acknowledges that the labeling changes have been instituted “to provide a more comprehensive description of risks related to nonmedical use, addiction, physical dependence, and withdrawal reactions.” The workshop is designed to share information on this problem from various stakeholders. The question is, where is this likely to lead? Perhaps changes in packaging, abuse-deterrent formulations, maybe even limits on quantities permitted to be prescribed? While there will likely not be any concrete decisions coming out of this information and idea-sharing session, it may shape the nature of future discussions and the next steps taken by the FDA to tamp down the abuse of benzodiazepines. The workshop notice on the FDA’s website can be found here.