Thar Pharmaceuticals received Orphan Drug Designation from the FDA for its zoledronate D,L-lysine monohydrate (ZLM) for the treatment of complex regional pain syndrome (CRPS).  CRPS is a rare form of chronic pain condition characterized by prolonged or excessive pain.  The causes of CRPS are not known and it is usually triggered by trauma or injury.  Currently, there is no FDA-approved medicine specifically for CRPS; and some patients do not respond to available treatment options and are left with unremitting pain and crippling changes.  Thar Pharmaceutical is a specialty pharmaceutical company based in Pittsburgh, PA that reinvents known drugs by improving clinical performance.  It filed US patents for ZLM preparation.  According to its website, ZLM is a fast-acting non-narcotic therapy for pain and Thar is reinventing this drug for other pain conditions.  Currently, there is one Phase II study sponsored by Novartis evaluating the efficacy of Zoledronate in CRPS patients.

 

Related Links:

http://www.google.com/patents/US20110028435
https://www.google.com/patents/US20130035315
http://www.tharpharma.com/product-pipeline/
https://clinicaltrials.gov/ct2/results?term=complex+regional+pain+syndrome&recr=&rslt=&type=&cond=&intr=zoledronate&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=
http://www.ninds.nih.gov/disorders/reflex_sympathetic_dystrophy/detail_reflex_sympathetic_dystrophy.htm