Pain Drug Reaches Phase 3 Clinical Trials

A Pittsburg-based drug development company has received U.S. Food and Drug Administration (FDA) approval for phase 3 clinical trials of a product to treat severe, persistent pain. The medication, T-121, is being developed by Thar Pharmaceuticals and is expected to enter the market by 2019.

T-121 is an oral version of Novartis’ intravenous-only zoledronic acid, which is sold under the brand name Zometra. T-121 will be intended for patients suffering from complex regional pain syndrome/reflex sympathetic dystrophy (CRPS/RSD), a chronic pain condition often brought on by some sort of trauma. About 70,000 people across the U.S. experience pain from CRPS/RSD, which can become chronic over time and become a disabling condition.

Treatments for CRPS/RSD

There are many different types of treatments for CRPS and new ones come about relatively frequently, although what works for one does not usually work for another, making treating the condition all the more difficult.

Generally, the earlier CRPS is caught and treated correctly, the greater the chance that the condition will respond to medical treatment.

Although most doctors agree that a combination of diet, exercise, physical therapy, and medication is the best treatment of CRPS for most patients, exactly what that combination may be and which medications work best is a highly debated issue among pain management doctors.

There are no FDA-approved treatments for the pain of CRPS/RSD. Thar Pharmaceuticals developed the drug through the FDA’s orphan disease program, which allows for expedited review, tax credits and other competitive advantages for medications that help fewer than 200,000 people. CRPS/RSD affects fewer than 200,000 patients in the U.S. each year, according to the National Organization for Rare Disorders.