NSAIDs are an $11-12+ billion market, yet the problems with these drugs continue to make headlines.
The most recent study examined data from nearly 450,000 patients, and concluded (our emphasis):
All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was comparable to that of traditional NSAIDS and was lower than for rofecoxib. Risk was greatest during the first month of NSAID use and with higher doses.
What we found truly astounding is this statement:
NSAIDs exhibited a rapid onset of risk for myocardial infarction in the first week of use.
The first week!
This comes on the heels of a variety of reports from folks who want drugs such as diclofenac banned:
“Diclofenac has no advantage in terms of gastrointestinal safety and it has a clear cardiovascular disadvantage…Because it’s been around for so long people have become familiar with it and almost don’t believe it could have a side effect like this.”
In other words, the mere habit of prescribing NSAIDs is causing prescribers to ignore/forget these side effects, which seems rather odd.
But What Are The Alternatives?
That is the question.
Multimodal Pain Management is gaining some traction. The idea here is to use a combination of safe, low-dose approaches to deal with pain. There are usually different combinations of drugs, and a blend of systemic versus local pain relievers to achieve pain control, especially in the post-op setting.
Devices are making a comeback in some circles. TENS, dTMS, and others are being revisited for patients with chronic pain, again in combination with lower-dose systemic drugs.
Cannabis legalization continues across the US, and around the world. As of this writing, we may soon have legalization across all of the New England states, in addition to Colorado and several others.
While some older users are simply continuing a practice started during their youth, it is also clear that many older users are doing so for medical reasons, including pain management and hospice support.
Is The Answer in the Pipeline?
MedTrack lists over 700 active programs for Pain, from Preclinical through Phase III.
However, a cursory review suggests that many of these candidates are reformulations of existing drugs, such as tramadol, diclofenac, and even menthol and acetaminophen.
Now to be clear, we are big supporters of companies who reformulate or improve existing pain products. Prescribers understand these drugs quite well.
So anything that improves their safety and/or efficacy would be welcome (if the payers would agree).
However, innovation in our understanding of pain, which leads to new chemical entities, would be quite welcome.
Moving forward, pain management will remain complex. Cheap NSAIDs will be favored by payers, but their inherent side effects will limit their use. The alternatives are increasingly complex and increasingly costly.
New Chemical Entities are desperately needed, but demonstrating superiority sufficiently to convince favorable reimbursement could be a challenge.