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RSD/CPRS Treatment: FDA Breakthrough Therapy

Progress Being Made in RSD/CPRS Treatment

In many cases, CPRS has been difficult to treat. Hearing that the FDA has deemed a drug a “breakthrough therapy” for CPRS treatment is encouraging.

RSD (Reflex Sympathetic Dystrophy) is an older name for the condition that today is called CRPS, which stands for Complex Regional Pain Syndrome. CPRS impairs the sympathetic nervous system and results in continuous, severe pain that goes beyond what is normal for the initial injury. This syndrome causes inflammation and produces symptoms in the skin, nerves, blood vessels and bones. It can also lead to short-term memory loss, spasms and various other symptoms.

While doctors do not know what causes CRPS, they do know it can manifest after an injury or surgery.

What Treatment Is Available for CPRS?

In 2016, the FDA categorized a CPRS treatment drug that was in clinical trial stages as a “breakthrough therapy.” The name of the drug is neridronic acid. Amiogen Pharma, which is an Italian drug manufacturer, discovered it. It is developing the drug jointly with Grünenthal, a German pharmaceutical company.

According to the Pain News Network, the FDA gave the drug a "Breakthrough Therapy" designation as a result of its Phase II clinical trial results. Treating CPRS patients with neridronic acid significantly reduced the pain and symptoms of CRPS.

Currently, there are no FDA approved treatments for CPRS. However, the FDA gave this drug both fast track and orphan drug designations. An orphan drug is a pharmaceutical drug being developed to treat a rare medical condition. Orphan disease is the term for a rare medical condition. The drug is currently in the Phase III trial stage. Once approved for the market, the Phase IV research trial begins where researchers evaluate long-term effects.

Individuals who meet the neridronic clinical trial requirements can participate in the clinical trial and receive treatments.

Are You or a Loved One a Victim of CPRS?

If medical malpractice was related to your CPRS condition, you may have recourse to recover compensation for injury. Compensation can help you offset the costly medical expenses involved with treating your condition.

At Sackstein Sackstein & Lee, LLP, we offer a free initial consultation to discuss CPRS and legal action to protect your rights.


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