All MSB holders are (or should be IMO) interested in the process of registration and approval of rexlemestrocel-l by the FDA for any indication, including especially CLBP which has seen a meteoric rise in importance to MSB since publication of the Phase III results.
This thread title and primary material has a focus on the Center for Disease Control's special interest in chronic pain and opioid usage. However I think the thread is sufficiently broad in intended scope to deal with a new and exciting FDA Guide development overnight for non-opioid
acute pain analgesics.
Although not directly relevant to rex-l registration IMO it shows the likley future direction FDA will take with CLBP licensure applications, including MSBs pending application & so is of immediate interest to holders (and use by MSB).
Here's the
link.
A link to the guidance table of contents can be found
here.
Note that the FDA starts its guidance by making the point that:
"
This guidance does not address the management of chronic pain, which will be the focus of a future guidance "
I dont think that reservation should discourage a close read of the Draft Guide, because so many of the issues and concerns of FDA in relation to acute pain and non-opioid drug prescription, marketing and use are common to chronic pain. In any case, the critical point is that the FDA considers non-opioid drug marketing in acute & chronic pain treatment to warrant special guidance for "opioid sparing" claims.
Now look at the express admissions the FDA makes in this Draft Guide, all of which IMO will help MSB prep its BLA and validate the clinical trial development & strongly indicate support from the FDA in those processes. For example, note - in no particular order - the following extracts:
"
This guidance is written in response to the statutory requirements of section 3001(b) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which directs the Food and Drug Administration (FDA) to issue or update existing guidance to help address challenges to developing nonaddictive medical products to manage pain. In keeping with the mandate of section 3001(b), and considering the severity of the ongoing opioid crisis, this guidance is also intended to assist sponsors in the development of alternatives to opioids for the management of acute pain. "
"
Endpoints Associated with Reducing or Eliminating Opioid Use
As discussed further below, total elimination of opioid or a numerical reduction in the number of doses, dose per day, or duration of opioid use may support the efficacy of the investigational drug in alleviating pain. In order to support a clinical benefit of a reduction in opioid use that would be described in labeling, sponsors should demonstrate a direct patient benefit, such as clinically meaningful reduction in the incidence and/or severity of opioid-induced adverse reactions. "
Wow, this is validation direct from the FDA of many of the items in CEO Itescu's report on MSB's discussions with the FDA on clinical trial design and focus. It should be music to Grunentahl's ears. We MSB holders know how safe rexlemestrocel-l is relative to other drugs. The FDA may well see that demonstrating an adverse reaction benefit is relatively straight-forward for rex-l.
Lets wait for the chronic pain analgesics guidance paper. But, golly gosh, MSB is definitely in the right place at the right time.
(20min delay)