…."an opiod paranoid FDA" is precisely what they are now, which to my mind makes me think they would be looking even more closely these days for a patch that delivers the same result with 75% less opioid and facing up to reality, opioids have their place in doing what they do, alleviating unbearable pain.
I don’t know that I’d go as far as to call the FDA “opioid paranoid”, but scrutiny and public pressure has certainly intensified around new opioid approvals.
In November last year, amid much debate, the FDA approved a new opioid product. The newly-approved drug, Dsuvia, is a sublingual tablet dosage form of the powerful opioid sufentanil, which is 1,000 times stronger than morphine. The drug is intended for fast pain relief during extreme trauma and was only approved for use in a medically supervised setting. Because of its potential usefulness on the battlefield, Dsuvia received funding and backing from the U.S. Department of Defense.
In a statement made on the approval of Dsuvia, FDA Commissioner, Scott Gottlieb, both provided justification for the decision to approve Dsuvia and outlined how he believed the FDA should consider the approval of future opioid pain medications. In his view, each candidate opioid should be evaluated “not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers.”
The FDA is currently evaluating a new framework for opioid approvals with the intention of providing new guidance for opioid drug sponsors. As part of this process, Gottlieb says the Agency will be considering questions such as:
How does the availability of an additional opioid drug benefit the public health through its ability to, for example, provide therapeutic differentiation, promote more appropriate access, or advance safer use of these medicines?
Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse, or other concerns?
If the approval of an additional opioid will create such added risks, will the new drug provide sufficient clinical differentiation that can benefit certain groups of patients, or offer other important clinical benefit, such that the benefits to patients of introducing the additional opioid outweigh the risks?
And can the implementation of REMS help mitigate some of these risks?
Gottlieb stated that such a framework would need to address the potential hurdles to product innovation and provide sufficient detail and transparency that innovators would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness.
It seems that if the TPM oxymorphone patch is to ever have a chance of being approved by the FDA, it will clearly need to be demonstrated that it is therapeutically different from or advances the safer use of opioids. It will also need to be shown that it can help address/minimise risks such as diversion, accidental overdose, abuse and misuse and/or that it can offer an important clinical benefit that outweighs the risks.
This appears to be what the FDA is seeking of future opioids, so this likely what any potential partners will also be seeking.
(20min delay)
