In an earlier article, Libby Parfitt discussed the remarkable breakthrough by researchers in Italy, who have successfully used intravenous Neridronate (also known as Neridronic Acid) to treat CRPS. 100% of those on the trial with early stage CRPS Type 1, achieved and maintained remission for at least a year.
Now, German pharmaceutical company, Grünenthal, has received a Breakthrough Therapy Designation from The American Food and Drug Administration for Neridronate for the treatment of CRPS.
A Breakthrough Therapy Designation can be granted to a drug if “it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition”. Essentially, this designation recognises the potential importance of the drug and puts it on the fast track towards approval.
However, in a move which further demonstrates that the pharmaceutical industry has woken up to the potentially huge market for a CRPS drug, Grünenthal has bought Thar Pharmaceuticals, who have their own CRPS drug known as T121.
T121 is an oral formulation of Zoledronic Acid which like Neridronate is a member of a class of drugs known as Bisphosphonates. Bisphosphonates are more commonly used to treat loss of bone mass and are commonly prescribed in the prevention and/or treatment of conditions such as osteoporosis and Paget’s disease. Initial trials using Zoledronic Acid to treat otherwise therapy resistant CRPS have proved very encouraging.
The takeover means that Grünenthal now have two of the most promising CRPS drugs, with the potential to corner the market by introducing intravenous and oral products in quick succession.
Grünenthal’s CSO, Klaus-Dieter Langner, said in a statement “our teams are highly motivated and will use all of their knowledge, experience and resources to bring these promising treatments to market for patients as soon as possible.”
The need for speed
As might be expected from a large commercial organisation, their need to act swiftly is not entirely altruistic. Rival company, Axsome Therapeutics is working on its own oral formulation of Zoledronic Acid that could pip T121 to market. Indeed, Thar had acknowledged that Axsome’s drug “may be available in the market and used as an off-label therapy for the treatment of pain associated with CRPS before we can commercialize T121.”
Benefit for CRPS sufferers
On the one hand it may seem somewhat distasteful that drug companies are looking to profit from CRPS. However, it must be recognised that the vast majority of drugs on the market today have only reached the stage where consumers can benefit from them as a result of the investment of drug companies.
The fact that drug companies have now recognised CRPS as a potentially huge market can, in the long term, only be of benefit to sufferers. Purely academic research can only get new products so far; it usually takes the vast research and development budgets of the pharmaceutical companies to get the drugs to the ultimate consumer.