The FDA plans to issue 4 separate guidances on pain products, commencing in the next 6 to 12 months.
- Assisting sponsors with the development of non-opioid medications.
- Addressing drugs that can spare the use of opioids in the treatment of acute pain. Risks associated with illicit use of treatments for acute pain will be explicitly considered.
- Outlining a path for extended-release local anaesthetics.
- Outlining the information the FDA will require manufacturers to provide regarding risks and benefits when new opioid pain drugs are put into development.
The first guidance won’t help POH.
The second guidance also is unlikely to benefit POH. There is an apparent preference for either avoiding opioids completely or limiting the prescribed opioid to 1-2 days supply (instead of the now-common 30 day prescriptions). Perhaps the one-day TPM patch might have a role to play here?
The third guidance makes me wonder about the potential of TPM/lidocaine and TPM/ropivicaine.
The fourth should surely benefit POH. It has a strong case to put forward that the TPM/opioid patch has increased benefits and reduced risk compared with current oral ER opioids.
https://www.empr.com/news/opioid-cr...analgesics-guidance-documents/article/792186/
https://www.practicalpainmanagement...tional-opioid-prescribing-starting-acute-pain
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