Our European client has developed a series of novel, patented salt forms of the most popular NSAIDS on the market (ibuprofen, naproxen, etc.).
Clinical data demonstrates three important properties of these new compounds:
Enhanced Safety – In multiple clinical studies, our client has shown that these novel salt forms have lower rates of severe mucosal GI damage compared to standard NSAIDS.
This effect is especially beneficial in patients who are most sensitive to the GI damage caused by NSAIDS.
Our client’s ibuprofen has demonstrated significantly lower incidence of mucosal gastroduodenal damage versus standard ibuprofen tablets, without the need for complex formulation technologies or the addition of side effect-masking drugs. Similar results were demonstrated with naproxen.
Rapid Onset – Our client’s candidates have demonstrated comparable Cmax and AUC versus standard NSAIDs, but with a much faster Tmax.
Studies have shown that rapid onset has benefits not only in acute pain, but also in chronic pain, where faster pain relief results in less remedication.
This has tremendous potential to reduce the use of opioids in the chronic pain market.
And, importantly, our client’s PK profile will be bioequivalent to existing products in many countries, resulting in a straightforward development process.
Taste Masking – Chewable tablets using our client’s technologies demonstrated complete taste masking, even in the absence of flavors or sweeteners.
This property could be used to develop taste-masked products for the pediatric, geriatric, and even the animal health markets.
The commercial potential of these products is significant:
Competitive Advantages – Our client’s approach is superior to any other NSAID-based product. For instance, our client’s products do not require H2 Antagonists or Proton Pump Inhibitors to mask the side effects of NSAIDs, thereby eliminating the need for poly pharmacy and reducing cost.
Further, our client’s lead product (ibuprofen salt) is inherently safer, thereby enabling share capture in a very large market dominated by inherently unsafe products, such as diclofenac and celecoxib.
Viable Switch Option – Physicians treating chronic pain invariable have patients who cannot tolerate NSAIDs. Current physician options are limited to adding protein pump inhibitors (complicating therapy and increasing cost), reducing dose (there reducing pain control), or switching to another NSAID (even when the initial choice was effective).
All of these problems are now resolved, as our client’s approach is safer, does not require poly pharmacy, and enables the physician to keep the patient on therapy longer.
Acute and Chronic Markets – Rapid-active NSAIDs have an obvious role to play in the acute pain markets.
But rapid acting NSAIDS are associated with significant GI side effects…side effects which are not present in our client’s product. However, the larger opportunity is in the chronic pain space.
Numerous studies demonstrate that rapid acting NSAIDs result in better overall pain relief, longer duration of pain relief, and a lower need for remedication.
Importantly, better pain relief also has the benefit of reduced opioid use.
Our client’s rapid acting, but safe ibuprofen drug candidate is perfectly positioned to succeed in this market with this positioning.
Our client is seeking development and commercialization partners for several of its clinical candidates. For more information, contact us via the form below: